GUIDE FOR THE

MINIMED™ 670G SYSTEM

WITH SMARTGUARD™ TECHNOLOGY

Medical Education
 TABLE OF CONTENTS

While every reasonable precaution has been taken in the preparation of this guide, GUIDE FOR THE MINIMED™ 670G SYSTEM WITH
Medtronic Diabetes assumes no responsibility for errors or omissions, nor for the SMARTGUARD™ TECHNOLOGY
uses made of the materials contained herein and the decisions based on such use.
KEY CONCEPTS FOR SMARTGUARD™ TECHNOLOGY 2
This document does not contain all of the information necessary for the proper
care and treatment of patients with diabetes. As such, no individual may rely SmartGuard™ Technology 2
on the information presented herein in forming a comprehensive treatment
programme or in treating any patient with diabetes. No warranties are made, Patient Responsibilities 3
expressed or implied, with regard to the contents of this work or to its applicability
Physician Responsibilities 3
to specific patients or circumstances. Medtronic Diabetes shall not be liable
for direct, indirect, special, incidental or consequential damages arising out of
the use or inability to use the contents of this guide. For a listing of indications, CLINICAL EVIDENCE 5
contraindications, precautions, warnings, and potential adverse events, please
refer to the Instructions for Use.
INITIATING SMARTGUARD™ AUTO MODE 6

Clinical Considerations 6

Instructions for Calculating Starting Doses 7

When Patients Use SmartGuard™ Auto Mode 8

When Patients Use Manual Mode 9

Activating Auto Mode 10

Graphs and Display 11

SMARTGUARD™ AUTO MODE FOLLOW-UP VISIT ASSESSMENT GUIDE 13

CARELINK™ SOFTWARE AUTO MODE REPORTS 15

REFERENCE SHEETS:

Alerts and Alarms in SmartGuard™ Auto Mode 28

Modes of Operation Reference Table 29

MiniMed™ 670G System Initiation Settings Form 31

REFERENCES AND SUGGESTED READING 33

 KEY CONCEPTS KEY CONCEPTS
2 3

This guide is for healthcare professionals and
will cover the initiation and adjustment protocol
for SmartGuard™ Technology with the MiniMed™
670G system for patients with type 1 diabetes.
This booklet does not include information on
basic pump usage and continuous glucose
monitoring (CGM), both of which are required
for SmartGuard™ Technology. Please refer to
the suggested reading section of this booklet if
you are not already experienced at initiating and
managing patients on insulin pump technology
and continuous glucose monitoring.
The components of the MiniMed™ 670G system
are the insulin pump with a reservoir, infusion
set, with a cannula that is placed subcutaneously;
the Guardian™ Sensor 3 and Guardian™ Link 3
transmitter, and the CONTOUR® NEXT LINK 2.4
meter for sensor calibration and fingerstick glucose
testing. The MiniMed™ 670G system functions as
a hybrid closed loop system because of a unique
insulin dosing algorithm built into the pump.*
Guardian™ Sensor 3
Infusion site
Guardian™ Link 3
transmitter MiniMed™
670G insulin
pump
10:00
AMAM
SMARTGUARD™ TECHNOLOGY
SmartGuard™ technology uses an automated
dosing algorithm that determines how much
insulin to give as micro-doses that can be delivered
as often as every 5 minutes. These automated
micro-doses replace basal insulin delivery and
target sensor glucose values to 6.7 mmol/L (120
mg/dL) (preset in the system, with the ability to be
set at a temporary target of 8.3 mmol/L (150 mg/
dL) by the patient). These micro-doses delivered
in SmartGuard™ Auto Mode are referred to as
Auto Basal. In addition, the system requires the
patient to use the bolus feature to enter grams
of carbohydrate and fingerstick BG values before
meals.
When the system is in Auto Mode, the algorithm
is controlling the delivery of basal insulin. When
the algorithm determines that sensor glucose
levels are not responding as expected or when the
system’s safety delivery limits have been reached,
the user will be alerted that they are no longer in
Auto Mode. At this point, the pump will default
to Manual Mode, delivering the patient’s pre-
programmed basal rates.
Auto Mode is an insulin delivery feature designed to
help people on intensive insulin therapy to achieve
better control 24 hours a day. This is achieved by
automatically controlling basal insulin delivery to
regulate glucose levels to a target sensor glucose
(SG) amount.
2. Prescribe Manual Mode insulin pump and
PATIENT
RESPONSIBILITIES
Operate the MiniMed™ 670G system including
entering fingerstick blood glucose values into the
pump to calibrate the sensor and entering both
blood glucose and carbohydrate information into
the bolus feature before meals. In addition, the
patient must wear the devices, keep them charged,
filled with insulin, and taped appropriately.
PHYSICIAN
RESPONSIBILITIES
1. Establish patient competencies with pump
technology and CGM technology. The
physician should ensure the patient operates
the pump and/or CGM properly, including the
Bolus Wizard™ feature. The priority is making
sure the patient is comfortable:
changing the reservoir and infusion set
inserting and calibrating sensors
navigating the menu on the device
carbohydrate counting
following safety protocols for treating
hyperglycaemia and hypoglycaemia.
The patient does not have to be “fine-tuned”
on pump technology prior to initiating
SmartGuard™ Auto Mode. It is also important to
make sure the patient has access to a computer
to download data from the MiniMed™ 670G
CGM settings (see the Initiation Settings
sheet on page 34) and determine when
SmartGuard™ Auto Mode will be initiated.
In order for Auto Mode to be enabled, the
algorithm requires a minimum of 48 hours
(starting at midnight) of insulin delivery
information that must be collected while the
patient is using the device. It is important
for the insulin delivery data collected to be
actual therapeutic values used by the patient
for diabetes management (and not practice
values). If the patient has been practicing with
the pump during training, use the “Clear Active
Insulin settings” feature under the “Manage
Settings“ menu prior to initiating insulin pump
technology.
When Auto Mode is enabled, the only two
adjustable settings that affect glycaemic
control are the Carb Ratio and the Active
Insulin Time. Since the algorithm is now
determining basal rates and correction
doses, none of the other pre-programmed
basal and Bolus Wizard™ settings are used
when in Auto Mode. However, because the
system will return the patient to Manual Mode
whenever safety limits are reached, the pre-
programmed basal rates, insulin sensitivity and
glucose targets must be current and properly
programmed into the pump.
NOTE The safety of using

0
6.9 System into the CareLink™ Personal software.
SmartGuard™ Auto Mode in
12
mg/dL 0.5 U
mg/dL 0.5lin U
Act. Insu

people who have no pump

experience is not known
*Other levels of automation within this system are outlined on the Modes of and should not be used if insulin pump
Operation Reference Table of this guide.
settings have not been established or if
the patient is not capable of managing
the insulin pump.
 KEY CONCEPTS
4 5
3. Establish patient expectations.
Setting expectations with your patients is
important. They will need to understand the
following concepts:

 The Auto Mode feature automatically controls
basal insulin delivery based on sensor glucose
values it receives from the transmitter. When
Auto Mode is active, the sensor glucose values
it receives from the transmitter are used to
automatically calculate the basal insulin dose.

 Auto Mode depends on reliable, accurate
sensor measurements and accurate entry of
carbs to deliver insulin for meals. Post meal
lows can occur if the patient overestimates
carb intake or boluses and does not consume
entered amount of carbohydrate.
Setting these expectations with your patients
will help ensure they continue on MiniMed™ 670G
System and experience the clinical benefits that it
can provide.
The patient will need to interact with the
system when in Auto Mode. It is important that
patients understand the Auto Mode feature still
requires their input:
they still need to enter BG values for boluses
and calibrations
they still need to respond to alerts and alarms
they will have to take action to re-enter Auto
Mode when the system exits Auto Mode
Although Auto Mode is aiming for 6.7 mmol/L
(120 mg/dL), patients should expect to see
sensor glucose values that are higher or lower.
The therapeutic goal is to safely maximise the
amount of time patients are spending in the
target range of 3.9-10.0 mmol/L
(70-180 mg/dL).
CLINICAL EVIDENCE
Below is a summary of evidence from the pivotal trial of the MiniMed™ 670G system.1, 2
METHODS There were 28 device-related adverse events
The study was conducted at 10 sites in the US that were resolved at home. There were 4
and Israel. Patients had type 1 diabetes for ≥2 serious adverse events (appendicitis, bacterial
arthritis, worsening rheumatoid arthritis, c-difficile
years, A1C <10%, were age 14-21 years old
(adolescents) or 22-75 years old (adults), and diarrhea) and 117 adverse events not related
to the system, including 7 episodes of severe
had been using insulin pump technology for ≥6
months, with or without CGM. hyperglycaemia due to intercurrent illness or
other non-system causes.
The pump was used in Manual Mode with CGM
during a 2-week run-in phase, then in Auto Mode The daily dose of insulin changed from 47.5 to
50.9 units/day; and weight from 76.9 to 77.6 kg.
in a 3-month study phase that included a 6-day,
5-night hotel stay for supervised activity and
SUMMARY
frequent venous BG measurements (during
Three months of unsupervised at-home use of
one 24 hour period) with a reference instrument
the MiniMed™ 670G system in SmartGuard™
(i-STAT). This was done to compare the sensor
Technology was safe, with no severe
glucose values of the system to venous blood
values to assess how the system was working. hypoglycaemia or DKA.
 he Guardian™ sensors used in the system
T
RESULTS were accurate.
There were 124 participants who were in the study. Compared to the run-in phase, SmartGuard™
Their mean age was 37.8±16, 30 were <21 years Technology was associated with less glycaemic
of age, and 94 were > 21 years of age, 44.4% were variability, more time in the target range, less
male. They had a mean duration of diabetes of exposure to hypo- and hyperglycaemia, and
21.7±13.65 year. The SmartGuard™ Technology reductions in A1C.
feature was used for a median 87.2% during
the 12,389 patient- days of the study period LIMITATIONS
(interquartile range, 75.0% to 91.7%). Single-arm, nonrandomised, pre-post design
Glycated hemoglobin (A1C) levels changed from with no pre-specified efficacy endpoints or
7.4±0.9% at baseline to 6.9±0.6% at study end. control group
Comparing sensor glucose values from the 2-week Data quantity imbalance between run-in and
run-in phase to the 3-month study phase, the study phases.
percentage of sensor glucose values within the 
Exclusion of subjects with A1C > 10%, recent
target range (3.9 - 10 mmol/L (71 - 180 mg/dL)) episodes of severe hypoglycaemia or recent
changed from 66.7% to 72.2%. The percentage DKA
of sensor glucose values <2.8 mmol/L (50 mg/dL) The result of the clinical trial must be
changed from 1.0+1.1% to 0.6+0.8%, <3.9 mmol/L interpreted with caution and an individual’s
(70 mg/dL) changed from 5.9+4.1 to 3.3+2.0% and results when using the MiniMed™ 670G system
>10.0 mmol/L (180 mg/dL) changed from 27.4+13.7 may be significantly different from those who
to 24.5+9.2%. Within-day standard deviation of participated in the trial.
glucose, a measure of glycaemic variability, changed
from 2.78 +0.55 to 2.59 + 0.40 mmol/L (50.1+9.9
Since this study did not include a control group,
no claims regarding effectiveness can be made.
to 46.7+7.3 mg/dL). Sensor and reference glucose
However, the study does support that the
values collected during the hotel stays were in good
device is relatively safe for use.
agreement, with an overall mean absolute relative
difference of 10.3±9.0%.
The authors would like to thank the pivotal study investigators for their valuable comments and suggestions on technology guidelines for hybrid closed loop:
Richard M. Bergenstal, MD; Bruce A. Buckingham, MD; Satish Garg, MD; Stuart A. Weinzimer, MD; Ronald Brazg, MD; Jacob Ilany, MD; Bruce Bode, MD, FACE; Timothy Bailey, MD, FACE;
Stacey M. Anderson, MD; Robert Slover, MD.
 INITIATING SMARTGUARD™ TECHNOLOGY
6 7
CONSIDERATIONS
See the complete list of warnings and
precautions in the MiniMed™ 670G System
User Guide.

 The algorithm requires the patient to have a
minimum Total Daily Dose of 8 units per day
and a maximum of 250 units per day.
 The system requires a minimum of 48 hours
(starting at midnight the day after pump start)
of insulin delivery.
 The Auto Basal target sensor glucose value is
6.7 mmol/L (120 mg/dL). This can be
temporarily adjusted to 8.3 mmol/L (150 mg/
dL) by the user for exercise or other conditions
in which the patient may be more concerned
about hypoglycaemia. In data obtained on the
home use of the MiniMed™ 670G System with
SmartGuard™ Technology, this temporary
target was rarely used.

 The patient shall enter grams of carbohydrate
for all meals and snacks and give the
recommended bolus.
 Additional grams of carb can be entered
anytime the patient realises they
underestimated the grams of carbs in a meal.
Examples include when they notice a post-
prandial high due to a pre-meal
underestimation of carbs, or when the amount
consumed was more than planned.
 hen a BG of 8.3 mmol/L (150 mg/dL) or
 W
higher is entered into the system, the algorithm
will calculate and may recommend a correction
bolus. Patient can cancel it to reject the
correction bolus, but they cannot adjust the
bolus amount.
 When calculating a correction dose in Auto
Mode, the algorithm will correct down to a
target of 8.3 mmol/L (150 mg/dL).

 Dual Wave™ bolus and Square Wave™ bolus are
not available in Auto Mode since the algorithm
will adjust basal delivery based on rise or fall of
glucose levels.
 The following dosing parameters can impact
Auto Mode delivery and may need to be
adjusted to maximise glycaemic control:
Insulin to Carbohydrate Ratio
(also referred to as Carb Ratio)
Active Insulin Time
 Medications containing acetaminophen may
falsely raise sensor glucose readings and
should be avoided while in Auto Mode. If taken,
patients should be advised to always use BG
meter readings to verify glucose levels and
consider exiting Auto Mode.

 Pay close attention to patients who start Auto
Mode with an A1C of 9% or above. They may
need a rapid carb ratio and active insulin time
adjustment if their insulin sensitivity increases
due to improved control.
INITIATING SMARTGUARD™ TECHNOLOGY
INSTRUCTIONS FOR CALCULATING
STARTING DOSES FOR SMARTGUARD
TECHNOLOGY
Manual Mode settings
Pump settings: If the patient is new to pump
technology, use the recommended calculations
for insulin pump initiation (see booklet Pumping
Protocol: A Guide to Insulin Pump Technology
Initiation). If the patient is on pump technology
and doing well, transfer the existing settings
over to the MiniMed™ 670G system.
INSTRUCTIONS FOR INSULIN PUMP
SETTINGS ADJUSTMENTS
If patient is new to pump technology:
If nocturnal, fasting/pre-meal or bedtime
BG > target, increase basal 10-20%
If nocturnal, fasting/pre-meal or bedtime
BG < target, decrease basal 10-20%
If post-meal BG > 3.3 mmol/L (60 mg/dL) above
pre-meal BG, decrease carb ratio by 10-20%
If post-meal BG < 1.7 mmol/L (30 mg/dL) above
pre-meal BG, increase carb ratio by 10-20%
Elevated BG: Verify trends 2-3 days before
adjusting
Low BG: Consider immediate adjustment
Recommendations adjustment for
Manual Mode:
Basal Rates: Nocturnal, fasting/pre-meal,
bedtime glucose: < 4.4 mmol/L (80 mg/dL),
decrease 10-20%; if > 7.2 mmol/L (130mg/dL)
or 8.3 mmol/L (150 mg/dL) at bedtime, increase
10-20%.
CONSIDERATION Assess
the current Basal/Bolus
Ratio. If the percent of basal
is greater than 50% of total insulin, basal
insulin may be helping to cover meals.
Consider decreasing basal rates by 10%
to reduce the amount of basal insulin and
decreasing carb ratios by 10% so that
more insulin is given for meals.

CGM settings: Use the SmartGuard™ Suspend
feature with CGM technology. Any CGM alerts
that are turned on in Manual Mode will also
occur when in Auto Mode. To decrease the
unnecessary and burdensome alerts in Auto
Mode, consider leaving these off unless the
patient plans to use Manual Mode for an
extended amount of time.
CONSIDERATION If
SmartGuard™ Auto Mode
is exited, the Manual Mode
suspend feature will be turned off.
Instruct the patient to turn it back on
if they plan to use Manual Mode for an
extended period of time.
SmartGuard™ Auto Mode settings:
Carbohydrate ratios: Use current ratios if
glucose control has been optimised. If patient is
experiencing post prandial hyperglycaemia,
decrease the carb ratio by 10% so that more
bolus insulin is given for meals. If there is post-
prandial hypoglycaemia, increase the carb ratio
by 10% so that less bolus insulin is given at meals.
The carbohydrate ratio should be reevaluated
within 1 week, looking at the 2-3 hour post meal
values to determine if adjustment is required.
Reevaluation should continue until post-prandial
glucose levels are in the target range.
Active Insulin Time: Evaluation of the pivotal
trial data showed most patients used 3 hours.
Based on this, the Active Insulin Time should be
set between 3 and 4 hours. Consider starting at
4 hours and adjusting in 15-30 minute
increments if needed. If correction boluses are
causing hypoglycaemia, then increase the
active insulin time. If correction boluses do not
appear to bring the glucose to the target range,
consider decreasing it. Reevaluate within one
week of starting Auto Mode, particularly by
looking at 2 hour post correction glucose levels.
 INITIATING SMARTGUARD™ TECHNOLOGY
8 9
Auto Mode BG Alert: This is an optional setting
that will have the pump alert when a blood
glucose entry is required. For the patient to
receive the audible alerts and help maximise the
time spent in Auto Mode, it is recommended to
leave this alert default setting On.
Alert on Low: When initiating Auto Mode it is
recommended that the alert is turned ON and
set to 3.8 mmol/L (or 70 mg/dL) or higher to
provide patient greater time to respond should a
low occur. As the patient gets accustomed to the
new technology and behaviours and is
comfortable using Auto Mode it can be adjusted
as needed.
Recommendations pump settings adjustment
before starting SmartGuard™ Auto Mode:
Sensitivity Factor: 4-hour glucose post-
correction: > 7.2 mmol/L (130 mg/dL), decrease
10–20% for more insulin; if < 4.4 mmol/L (80 mg/
dL), increase 10-20% for less insulin.
Carb Ratio: Post-meal glucose: > 3.3 mmol/L
(60 mg/dL) above pre-meal glucose, decrease by
10% for more insulin; if hypoglycaemia occurring,
increase by 10% for less insulin.
Active Insulin Time: 2-3 hour post-correction
glucose > target, decrease by 15-30 minutes;
if < target or hypoglycaemia results, increase by
15-30 minutes.
Evaluate the settings within one week of initiating
Auto Mode, and follow-up as indicated per
individual response to technology, using
CareLink™ software. For information about
CareLink™ software report interpretation, refer
to the CareLink™ Software Auto Mode Reports
section of this guide.
WHEN PATIENTS USE SMARTGUARD™
AUTO MODE
Auto Mode: The MiniMed 670G system has
™ they wish to use Manual Mode. For Manual Mode
many safety parameters that limit the amount and
duration of Auto Basal insulin delivery. Auto Mode
should be considered more as a basal adjuster, and
users should be reminded as to the importance
of taking bolus insulin via the bolus feature prior
to eating and when suggested by the pump for
correction of high glucose levels. By design, the
algorithm does not administer large dose insulin
adjustments, such as those required to quickly
resolve hyperglycaemia resulting from technology
mismatches. For example, if a patient consumes
more carbohydrate than what was entered into
the bolus feature, or if the user gives a bolus for
food and then eats more without giving an additional
bolus, the algorithm used in Auto Mode may not be
able to rapidly compensate.
Safe Basal: While in Auto Mode, there will be times
when Safe Basal is activated. Safe Basal occurs
when there is a situation preventing Auto Mode
to adjust insulin based on SG values. Safe Basal
is designed to allow patient the time to perform
additional actions required to ensure Auto Mode
remains active. The following is a list of some
conditions that will activate Safe Basal:
An SG reading is not available because the
transmitter and pump are not communicating,
or the sensor calibration has expired.
The sensor might be reading lower than the
actual glucose values.
The BG value is different from the SG value by
35% or more.
After a sensor change, during the sensor
warm up.
Auto Mode has been at the personal Auto Mode
minimum delivery rate for 2 1/2 hours.
Auto Mode has been at the personal Auto Mode
maximum delivery rate for 4 hours.
INITIATING SMARTGUARD™ TECHNOLOGY
During Safe Basal, a fixed basal rate is delivered
which has been calculated by the algorithm based
on past Auto Basal delivery amounts. Insulin
will not be automatically adjusted based on SG
values during this time. Safe Basal can last up to
90 minutes allowing patient the time to perform
additional actions without exiting Auto Mode.
Auto Basal will resume as soon as the condition
is corrected or will enter Manual Mode after 90
minutes if the condition has not been resolved.
Auto Mode Exit: When a condition exists that causes
the pump to exit Auto Mode, it enters Manual Mode.
There are some instances where Safe Basal will be
bypassed and Auto Mode exited immediately (i.e.
prolonged hyperglycaemia). When this occurs, the
goal is to have the patient address the reason the
exit occurred and return to Auto Mode as quickly
as possible. During training, patients will be taught
to access the Auto Mode Readiness screen to help
determine what is needed for Auto Mode re-entry.
When first initiating hybrid closed loop, the patient
should view an automatic exit of Auto Mode as a
learning experience. As the patient uses the system
for a longer time period, it should be expected they
will learn to avoid the common triggers and potentially
exiting Auto Mode will happen less and less.
WHEN PATIENTS USE MANUAL MODE
Patients may manually exit Auto Mode any time
use that is not temporary, the Bolus Wizard™
calculator and Basal Pattern settings should
be reviewed and adjusted as necessary. It is
recommended to instruct patients to turn on
Suspend before low when using the pump in
Manual Mode.
SmartGuard™ Suspend features: Suspend
before Low
Suspend before low is a feature that is only
available in Manual Mode and must be turned
on by the user. When Suspend before low is
on, insulin delivery is suspended when glucose
levels are predicted to be approaching the low
limit in 30 minutes*. Additionally, basal insulin
delivery will auto resume in 2 hours, or sooner
if the sensor glucose is above the low limit and
trending upward.** Although Suspend on low is
an available feature that will stop insulin delivery
when the low limit is reached, Suspend before low
is the preferred feature for most patients for use
in Manual Mode since this feature is designed to
suspend insulin delivery before the glucose level
is low, helping glucose levels to recover and ideally
help avoid a hypoglycaemic event.
*Insulin delivery is suspended when sensor glucose is at or within 3.9 mmol/L (70
mg/dL) above the low limit and predicted to be at or within 1.1 mmol/L (20 mg/dL)
above the low limit in 30 minutes.
** Insulin delivery resumes when sensor glucose is at least 1.1 mmol/L (20 mg/dL)
above the low limit and predicted to be more than 2.2 mmol/L (40 mg/dL) above in
30 minutes.
 INITIATING SMARTGUARD™ TECHNOLOGY
10
When using the Suspend before low feature, insulin
delivery can be suspended, low SGs avoided and
insulin delivery resumed. Since the suspend and
resume alerts can be turned off and patients only
alerted if the low limit is reached, this can all occur
without the patient being interrupted. This can be
especially appealing during the nighttime hours so
that sleep is not disturbed. If the suspend occurs
during the day near a snack or meal time, the
patient can be directed to manually resume basal
insulin so a bolus can be given as needed.
30 min Low Limit
The effectiveness of Suspend before low to avoid
low SGs is dependent on the severity of the drop
in glucose levels. If the low limit is reached despite
insulin being suspended, the patient will always
receive an alert. If that low alert is not addressed
within 10 minutes, the pump will siren until cleared.
NOTE When Auto
Mode is active, the
SmartGuard™ Suspend
features are unavailable. If the
pump exits Auto Mode, the
Suspend features are not active
until the patient manually
enables them.
INITIATING SMARTGUARD™ TECHNOLOGY
11
ACTIVATING SMARTGUARD™ AUTO MODE AUTO BASAL

Auto Mode cannot be initiated until the pump has a After Auto Mode has been turned on and each of the Auto Mode Readiness steps has been completed, Auto
minimum amount of historical insulin delivery Mode becomes active. When Auto Mode is active, a large shield outlined in blue, with a sensor glucose value,
information to drive the algorithm. This information appears on the center of the Home screen. If this Home screen is displayed, the pump is in Auto Mode, and is
is collected in the warm-up period, which begins the delivering Auto Basal.
midnight after the pump starts delivering insulin
until 48 hours later. The system, however, will
continue to collect delivery information until Auto
Mode is actually initiated. Although not required, it is
recommended that your patient use a sensor
during this time period before Auto Mode initiation. SmartGuard™
‚‚ We recommend Manual Mode with CGM Auto Mode shield
use for ≥7 days before transitioning to
Auto Mode. SG value
‚‚ The Auto Mode feature should be left off Active insulin
during the system warm-up to avoid an
Auto Mode entry alert at midnight when
the warm-up is completed.
‚‚ The Auto Mode warm-up does not need to be
repeated when the sensor is changed, but it
maybe required after a long “turn-off” period.
To enter Auto Mode, the Sensor option must be SAFE BASAL
turned on and the user must be wearing an The pump automatically transitions to Safe Basal delivery from Auto Basal delivery when valid sensor glucose
active, calibrated sensor. values are not available or minimum or maximum Auto Basal delivery limits have been reached. Safe Basal is
The Bolus Wizard™ settings must be entered. automatically calculated by the system’s algorithm. It uses recent insulin delivery to calculate a safe fixed basal rate.
The Carb Ratio and Active Insulin Time will be
used and adjusted for Auto Mode. When in Safe Basal, the pump will display an outline of the Auto Mode shield in white, as shown below.
 At the time of enabling Auto Mode, the pump Depending on the situation, there may or may not be an SG reading displayed. If there is an action that can be
taken by the patient to address the condition, the pump will indicate the action to take as shown here
cannot be delivering a bolus or a temporary
basal and cannot have insulin delivery (BG required).
suspended. If any of these conditions exist, the
patient must wait until the process has
completed, or cancel the process, before Auto
Mode will work.
If a blood glucose value has not been entered
within the past 12 minutes, a BG will be required to
activate Auto Mode. The pump will indicate when it
will be time to enter a blood glucose value.
If Auto Mode does not activate, the Auto Mode
Readiness screen can be checked to see what
needs to occur for Auto Mode to re-start.
(see Auto Mode Readiness screen on page 9)
 INITIATING SMARTGUARD™ TECHNOLOGY SMARTGUARD™ AUTO MODE FOLLOW UP VISIT
12 ASSESSMENT GUIDE 13

VIEWING THE SENSOR GRAPH IN SMARTGUARD™ AUTO MODE Use the information below as a reference while assessing CareLink™ software reports during follow-up visits
with those patients using SmartGuard™ Auto Mode.
Here is an example of the CGM graph that is displayed when in Auto Mode.

GENERAL ASSESSMENT
Observations Questions to Ask Possible Actions
Time Span
Review need for consistent sensor wear
 Sensor Wear percentage Is sensor wear <90%?
Address solutions for increasing sensor use

Auto Basal Deliveries Review Auto Mode Exits to help reduce

the occurrence (see next page)
Correction Bolus  Percent time in Auto Mode Is the percent time in Auto Mode <80%?
Explore difficulties with timely re-entry
into Auto Mode
High Alert Most Current SG Is hypoglycaemia occurring when in Decrease basal rate during that time
mmol/L Scale  Glucose levels when in Manual Mode? period by 10-20%
BG Entry Manual Mode Increase basal rate during that time
Is hyperglycaemia occurring when in
“Desired Range” Manual Mode? period by 10-20%
Low Alert (green band) BOLUS ASSESSMENT
Observations Questions to Ask Possible Actions
Bolus, BG, SG value, and Time
Counsel patient on carbohydrate counting
 Post meal bolus Are carbohydrate counting skills
hypoglycaemia adequate?
Increase Carb Ratio setting so less
SG Readings over Carb Bolus bolus insulin is given
Time (blue line)
Are carbohydrate counting skills Counsel patient on carbohydrate
adequate? counting and timing meal bolus
 Post meal hyperglycaemia Are meal boluses being given prior to
Decrease Carb Ratio setting so more
TEMPORARILY ADJUSTING SMARTGUARD™ AUTO MODE TARGET (when post meal rise is ≥ 3.3 meal? bolus insulin is given
mmol/L (60 mg/dL) above For high-fat meals, consider giving 2
The standard Auto Mode target is 6.7 mmol/L (120 mg/dL). This target can be temporarily changed to 8.3
pre-meal level) Are additional carbs being entered meal boluses; one pre-meal for carbs
mmol/L (150 mg/dL) for up to 12 hours for times when it is necessary for the Auto Mode target to be raised. when the patient consumes more and another 1-2 hrs later for the delayed
While the temporary target is being used, the Home screen will display Temp Target and the time remaining than what was originally estimated? glycaemic rise from fat
until the normal target of 6.7 mmol/L (120 mg/dL) automatically resumes.  Post correction Are correction boluses causing
Increase Active Insulin Time
hypoglycaemia hypoglycaemia?
 Post correction Are correction boluses causing
Decrease Active Insulin Time
hyperglycaemia hyperglycaemia?
NIGHT-TIME ALERT ASSESSMENT
Observations Questions to Ask Possible Actions
Instruct patient to verify Auto Mode
status prior to bed
Encourage patient to test BG and
 Nocturnal alerts Have alerts occurred during sleep?
calibrate prior to bed
 nsure any recommended correction
E
bolus is being taken prior to bed
ACTIVITY ASSESSMENT
Observations Questions to Ask Possible Actions
Counsel patient to use Temp Target of
 Hypoglycaemic patterns Is exercise causing hypoglycaemia?
8.3 mmol/L (150 mg/dL) during exercise
 SMARTGUARD™ AUTO MODE FOLLOW UP VISIT MAKING ADJUSTMENTS BASED ON
14 ASSESSMENT GUIDE CARELINK™ SYSTEM INSIGHTS 15

CareLink™ system generates easy-to-read reports that allow healthcare professionals to quickly
assess vital insights in order to fine-tune therapy.

AUTO MODE EXIT ASSESSMENT METHODOLOGY FOR Assessment and Progress

Reason for Exit Questions to Ask Possible Actions INTERPRETATION (AIM)

A 7-2-2016 - 7-15-2016 (14 Days) B 5-11-2016 - 5-24-2016 (14 Days)

Percentile comparison 25-75% 0-90% Average A

22.2

 einforce the importance of calibration

16.7

R
Does patient know the steps to take to The following reports were designed
11.1
10.0

based on schedule; review methods

3.9

calibrate?
mmol/L 2.2

to facilitate the interpretation of SmartGuard™

24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Carb Ratio
A 20.0 10.0 15.0 17.0 20.0

Counsel patient that calibrating before

(g/U) *
B 20.0 12.0 18.0 17.0 20.0

Hypoglycemic patterns(2) Hyperglycemic patterns(2)

A

Auto Mode data. These reports allow you

7:21 - 8:31 17:04 - 17:34
1 2 3 8:00 - 9:45 4 18:40 - 20:15
(1 occurrences) (1 occurrences)

bedtime may decrease the frequency of A B Auto Mode Exits A B Statistics A B

Does patient understand their calibration

4%

to Assess, Identify and Make Changes to

7% No Calibration •• 2 0 Auto Mode (per week) 96% (6d 18hrs) 0% (0hrs)

unscheduled Calibrate now alerts during

17% High SG Auto Mode Manual Mode (per week) 4% (6hrs) 100% (7d 00hrs)
0 0
20% Exit
Auto Mode max Sensor Wear (per week) 95% (6d 16hrs) 95% (6d 16hrs)

schedule?
0 0
delivery Average SG ± SD 8.3 ± 2.8 mmol/L 8.3 ± 3.0 mmol/L
Auto Mode min

Time in range
0 0

the night
delivery Estimated A1C 6.8% 6.8%

technology.
BG required for Auto
Mode • 1 0 Average BG 9.7 ± 4.1 mmol/L 8.1 ± 3.4 mmol/L
Sensor Algorithm BG / Calibration (per day) 7.8 / 4.1 10.2 / 3.8
0 0

 Missed Calibrations
77% Underread
70%
Sensor Updating 0 0 Total daily dose (per day) 23 units 18 units
No SG values •• 2 0 Bolus amount (per day) 14U (61%) 9U (49%)

 einforce entry of calibration BG anytime

R
Sensor Expired 0 0 Auto Basal / Basal amount (per day) 9U (39%) 9U (51%)
Auto Mode disabled by 3.9 4.1

1. Using the Assessment & Progress report,

Set Change
user • 1 0

Are calibration alerts occurring during

2% 3% Reservoir Change 3.9 4.1
Alarms •• 2 0

prompted on pump screen

2.2 3.0 3.9 10.0 13.3 22.2 mmol/L Meal (per day) 7.0 5.5
Pump Suspend by user 0 0
Carbs entered (per day) 166 ± 42g 140 ± 28g
Auto Mode Warm Up 0 0

the night?
Active Insulin time 3:00 hrs 3:00 hrs

assess the overall mean sensor glucose on

* Most recent pump settings are displayed
Unidentified •• 2 2 ••

Counsel patient that calibrating 3-4 times
a day, spread throughout the day, may
Is patient aware of occasional need for
minimise the frequency of additional
additional calibrations?
unscheduled Calibrate now alerts
Assessment and Progress Report (p. 16)
the Percentile Comparison chart. Focus on
the degree of glucose variability, taking note
of the hypoglycaemic and hyperglycaemic
Weekly Review (1 of 2)
7-2-2016 - 7-8-2016 (7 Days)

Are meal boluses being given prior to

22.2

Counsel patient on carbohydrate patterns. Minimising the frequency of

16.7
14.8

meal?
11.4 11.4
11.1 10.8 10.5
9.8 10.2
10.0 9.1 9.5 8.4

hypoglycaemia episodes should always

8.9 9.1 8.4 8.6 8.4 8.5
8.2 8.0
7.1 7.4

counting and timing of meal bolus

4.8
3.9
3.9 2.8
2.2
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0

Are additional carbs being added when

overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner

be addressed.

Basal (U/hr)
consumed above what was originally Ensure the additional carbs are entered
and bolus given when more carbs are
Exit Reason Details

estimated? 2. Assess time in range and identify

1,5 - No Calibration

 High SG Auto Mode Exit

22.2
Sensor was not calibrated (e.g. Calibration not
accepted, BG not received, No Calibration

consumed than originally estimated

occurred, etc.).
16.7

13.4 13.2 13.3 2 - No SG values

12.2

Is BG being tested and entered to assess hypoglycaemic time in range greater than
10.8 11.0 10.8 SG values were not available (e.g. Lost sensor
11.1 10.1
10.0 8.4 9.2 signal, Change sensor, Check connection,
7.8 Transmitter depleted, Sensor signal not found,
7.2

Ensure BG readings are entered for

6.4 etc.).
5.6 6.0
4.9
3.9 3 - Alarms

need for correction bolus?

2.2
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 Auto Mode exit due to an alarm.

3%. Assess Auto Mode exit frequency,

overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner

Basal (U/hr)
correction boluses and the boluses are
4 - Unidentified

Pump did not enter Auto Mode or the origin of

the exit cannot be identified.

Are recommended correction boluses being delivered Statistics for time in Auto Mode, sensor wear Blood Glucose Manual Suspend Suspend Bolus Target Exercise
6 - BG required for Auto Mode

BG was required to continue in Auto Mode.

being given?
Auto-Basal Basal Injection Time change
Calibration Suspend on Low before Low + Active Insulin + temp target Other

Are meal boluses being skipped?
Are meal boluses being given before meal?
Counsel patient on carbohydrate
counting and timing of meal bolus
time, blood glucose (BG) levels, calibrations Weekly Review Report (p. 21)
and basal / bolus percentage. All should be
assessed for appropriateness.
Meal Bolus Wizard
7-2-2016 - 7-15-2016 (14 Days)

Ensure the additional carbs are entered

All Meal Boluses Meal Boluses Analyzed: Boluses with noteworthy pattern or outcome are used for analysis

Are additional carbs being added when

Breakfast - All Boluses Stats Breakfast - Analyzed Meals Observations
Avg. SG

3. Assess post-prandial control using the Meal

(mmol/L) 10.6 10.2
Time 6:00 - 10:00

and bolus given when more carbs are

22.2

consumed above what was originally

Bolus Count 30

Glucose (mmol/L)
16.7

Carb Ratio (g/U) 12.0

11.1
10.0

consumed than originally estimated

Avg. Carbs (g) 31 ± 24

 Auto Mode max delivery estimated? Bolus Wizard report.

3.9
2.2 Avg. Bolus (U) 3.0 ± 2.4

Lunch - All Boluses Stats Lunch - Analyzed Meals Observations

Avg. SG
(mmol/L) 7.8 7.3
Time 11:00 - 15:00
22.2

 nsure BG readings are entered for

E
Bolus Count 30

Is BG being tested and entered to assess

Glucose (mmol/L)
16.7

4. With the Weekly Review report, identify

Carb Ratio (g/U) 17.0
11.1
10.0
25 ± 17

correction boluswes
Avg. Carbs (g)
3.9

need for correction bolus?

2.2
Avg. Bolus (U) 1.7 ± 1.2

Auto Mode exit reasons, post-prandial and

Dinner - All Boluses Stats Dinner - Analyzed Meals Observations
Avg. SG
Time 16:00 - 22:00

Counsel patient to test BG and give

(mmol/L) 10.1 8.2
22.2
Bolus Count 29

Glucose (mmol/L)
Are the max delivery timeout alerts
16.7

Carb Ratio (g/U) 15.0

post-correction trends, based on findings

11.1
10.0
Avg. Carbs (g) 20 ± 13

recommended correction bolus at bedtime

3.9

occurring during the night?

2.2 Avg. Bolus (U) 1.2 ± 0.8

Night - All Boluses Stats Night - Analyzed Meals Observations

determine need to make adjustment to carb

Avg. SG
(mmol/L) 11.0 9.0
Time 22:00 - 6:00
22.2
Bolus Count 2

Glucose (mmol/L)
16.7

Carb Ratio (g/U) 20.0, 20.0

 Auto Mode min delivery Is this occurring after exercise? Consider using temp target for exercise
11.1
10.0

ratio and/or active insulin time.

Avg. Carbs (g) 7±2
3.9
2.2 Avg. Bolus (U) 0.3 ± 0.1

Meal Bolus Wizard Report (p. 24)

What are the reasons patient is choosing
to exit Auto Mode?
Encourage patient to stay in Auto Mode
as much as possible
Address any concerns that are causing
5. Make changes and document findings,
setting adjustments, Auto Mode coaching
and follow-up plan on the Device Settings
Device Settings
7-10-2016

 Auto Mode disabled by user SmartGuard Basal (Continued) Reminders

patient to exit Auto Mode report.

Auto Mode Basal 4 Basal 5 Workday Day Off Sick Day Low Reservoir Warning Insulin Units

Auto Mode On 24-Hour 24-Hour 24-Hour 24-Hour 24-Hour Amount 20 U

-- -- -- -- --
Total Total Total Total Total
Auto Mode BG Alert Off Bolus BG Check Off

Are there issues that can be addressed

Time U/Hr Time U/Hr Time U/Hr Time U/Hr Time U/Hr Set Change Off

Ensure Suspend before low is On when

High Alerts On (Snooze 1:00)
-- -- -- -- -- -- -- -- -- -- Missed Meal Bolus
Start Alert Alert
Rise Alert
Time On Before Name Start End
High (mmol/L) Limit(mmol/L)
High High

The following pages discuss CareLink™

Meal 1 Off Off
0:00 16.7 x

to help this from occurring?

8:00 15.3 x Meal 2 Off Off
15:30 15.3 x
Meal 3 Off Off

patient is not in Auto Mode

Meal 4 Off Off
Meal 5 Off Off
Meal 6 Off Off

reports and provide guidance on using the

Meal 7 Off Off
Low Alerts On (Snooze 0:20)
Alert Resume Meal 8 Off Off
Start Low Alert
Suspend Before Basal
Time (mmol/L) On Low
Low Alert
Personal Reminders
0:00 3.6 Off x Name Time
Reminder 1 Off

information provided.
Reminder 2 Off
Reminder 3 Off
Reminder 4 Off
Reminder 5 Off
Sensor Reminder 6 Off
Sensor On BG Check Off
Medication Off
Calibration Reminder On

Calibration Reminder Time 1:00 Utilities

Block Mode Off
Notes Time Format 24 Hr
Brightness Auto
Backlight Timeout 60s

Remote Bolus On
Audio Options Vibrate
Alarm Volume --
Auto Suspend Off

Device Settings Report (p. 26)

 CARELINK™ SYSTEM INSIGHTS FOR SMARTGUARD™ CARELINK™ SYSTEM INSIGHTS FOR SMARTGUARD™
16
AUTO MODE – ASSESSMENT & PROGRESS REPORT AUTO MODE – ASSESSMENT & PROGRESS REPORT 17

REVIEWING SMARTGUARD™ AUTO MODE REPORTS FOR MINIMED™ 670G SYSTEM – 1 REPORTING TIME PERIODS AVAILABLE
Assessment and Progress
Assessment
AAssessment and
andProgress B
1
7/2/2016 - 7/15/2016 (14 Days)
Progress 5/11/2016 - 5/24/2016 (14 Days)

AA 7/2/2016
7-2-2016- -7/15/2016
7-15-2016(14
(14Days)
Days) B
B 5/11/2016
5-11-2016--5/24/2016
5-24-2016(14
(14Days)
Days)
Percentile comparison 25-75% 0-90% Average A

ASSESSMENT AND PROGRESS

22.2
Percentile 25-75%
25-75% 0-90%
0-90% Average AA
Average
Percentilecomparison
comparison
22.2
22.2

16.7

16.7
16.7

Assessment and Progress

11.1
10.0
11.1
11.1
10.0
10.0

The Assessment and Progress report is generated when there is MiniMed™ 670G pump and sensor data.
3.9
mmol/L 2.2
3.9
3.9
24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

B
mmol/L
mmol/L2.2
2.2

A
2424 11 22 33 44 55 66 77 88 99 10
10 11
11 12 15 16 17 18 19 20 21 22 23 2424
A 20 10 15 13 14 15 16 17 18 1719 20 21 22 23
20

7/2/2016 - 7/15/2016 (14 Days) 5/11/2016 - 5/24/2016 (14 Days)

Carb Ratio
(g/U) *
Carb
Carb RatioB
Ratio
AA 20.0
20 12 10
10.0 18 15
15.0 17
1717.0 20
20.0
20
(g/U) **
(g/U)
BB 20
20.0 12
12.0 18
18.0 17
17.0 20
20.0

It will provide information when the patient is both in Auto Mode and Manual Mode. Note: If only pump data is
Hypoglycemic patterns(2) Hyperglycemic patterns(2)
A Hypoglycemic
Hypoglycemicpatterns(2)
patterns(2) Hyperglycemic patterns(2)
AA 1 7:21 - 8:31 2 17:04 - 17:34 3 8:00 - 9:45 4 18:40 - 20:15
(1 occurrences) (1 occurrences)
11 7:21
3
7:21- -8:31
8:31
22 17:04
17:04--17:34
17:34
3 8:00 - 9:45 44 18:40
18:40 -- 20:15
20:15
(1 occurrences)
(1 occurrences) (1 occurrences)
(1 occurrences)

A B Auto Mode Exits A B Statistics A B

available, only the Statistics information will appear.

4% AA BB 7% Auto Mode
Auto Mode Exits
Exits A
A B Statistics AA BB
4%
No Calibration •• 2 0 Auto Mode (per week) 96% (6d 18hrs) 0% (0hrs)
4% 7%
7% NoCalibration
High
No Calibration
SG Auto Mode •• 22 0 Auto Mode
Mode
Manual (per
(per
Mode week)
week)
(per week) 96%
96%(6d
4%18hrs)
(6d 18hrs)
(6hrs) 0%
0%(0hrs)
(0hrs)
100% (7d 00hrs)

25-75% 0-90%
17% 0 0

Range A
20% Exit
HighSGSGAuto
AutoMode
Mode
17%
17% High Manual Mode (per
Mode (per
Sensor Wear week)
(per week)
week) 4%
4%(6hrs)
95% (6d (6hrs)
16hrs) 100% (7d
100%(6d
95% 00hrs)
(7d16hrs)
00hrs)
00

Percentile comparison
20% Auto
Exit Mode max 0
20% Exit 0 0
delivery
AutoMode
Modemax
max Sensor
AverageWear
SG ±(per
Wear SD week)
(per week) 95%
95%
8.3 (6d 16hrs)
(6dmmol/L
± 2.8 16hrs) 95%
95%±(6d
8.3 3.016hrs)
(6d 16hrs)
mmol/L
Auto
Auto Mode min
delivery 00 0

range
delivery 0 0 Average SG
SG ±± SD
SD 8.3
8.3 ±±2.8
2.8mmol/L
mmol/L 8.3
8.3±±3.0
3.0mmol/L
mmol/L
delivery Estimated A1C 6.8% 6.8%
AutoMode
Auto Modemin
min

range
in range
BG required for Auto 00 0 Estimated A1C
A1C 6.8%
6.8% 6.8%
6.8%
delivery
delivery
Mode
BGrequired
requiredfor
forAuto
Auto
• 1 0 Average BG 9.7 ± 4.1 mmol/L 8.1 ± 3.4 mmol/L
BG
• 11 0

in
Sensor
Mode Algorithm Average BG
BG
BG / Calibration (per day) 9.7
9.7 ±±4.1
4.1mmol/L
mmol/L
7.8 / 4.1 8.1
8.1±±3.4
10.2 3.8mmol/L
/3.4 mmol/L

22.2
Mode 0 0
77% Underread

Time
SensorAlgorithm
Algorithm

in
70% Sensor BG
BG // Calibration
Calibration (per
(per day) 7.8
7.8//4.1 10.2
10.2/ /3.8
77%
77% Underread 00 00 day) 4.1 3.8
Underread
Sensor Updating 0 0 Total daily dose (per day) 23 units 18 units

Time
Time
70%
70%
Sensor Updating 00 00 Total
Total daily dose (per day) 23
23units 18
18units

Range A is a customisable time period that represents the current

Sensor
No Updating
SG values •• 2 Bolus daily dose
amount (per
(per day)
day) 14U units
(61%) 9U units
(49%)
NoSG
No SGvalues
Sensor values
Expired •• 22
0 00 Bolus amount
BolusBasal
Auto amount (per day)
(peramount
/ Basal day) (per day) 14U
9U(61%)
14U (61%)
(39%) 9U
9U(49%)
(49%)
(51%)
Sensor
Sensor
Auto Expired
Expired
Mode disabled by 00 00 Auto
Auto Basal
Basal // Basal
Set Change Basal amount
amount (per
(per day)
day) 9U
9U(39%)
(39%)3 9U
9U(51%)
3 (51%)
user
AutoMode
Modedisabled
disabled by
by
• 1 0
3.93 4.1
Set
Set Change
2% 3% Auto • Change
• ••
11 00 Reservoir Change 3
user
user
Alarms 2 0
2% 3%
3% Reservoir 3.93 4.1
2% Reservoir Change
Change 3
2.2 2.8 3.9 10.0 13.3 22.2 mmol/L
Alarms
Pump
AlarmsSuspend by •• •• 2
0
2 0
0
0 Meal (per day) 7.0 5.5
user Meal
Meal (per day) 7.0 5.5

date range of pump and sensor information. The reporting period,

2.2 3.0 3.9 10.0 13.3
13.3 22.2
22.2 mmol/L
mmol/L Pump Suspend (per day) (per day) 7.0 5.5 ± 28g
2.2 2.8 3.9 10.0 Suspendby
Pumptime/date
Large by user 00 00 Carbs entered 166 ± 42g 140
user 0 0 Carbs
change Carbs entered
entered (per
(per day)
day) 166
166±±42g
42g 140
140±±28g
28g
Large time/date Active Insulin time 3:00 hrs 3:00 hrs
4 5 6
Auto Mode Warm Up 00 00
* Most recent pump settings are displayed
Unidentified
change •• 2 2 •• Active
Active Insulin
Insulin time
time 3:00
3:00hrs
hrs 3:00
3:00hrs
hrs
•• •• •• ••
* Most recent pump settings are displayed
Unidentified 22 22
* Most recent pump settings are displayed
Unidentified

Assessment and Progress

Assessment
AAssessment and
andProgress B 16.7
shown in blue, defaults to 14 days from the date of download and
1
7/2/2016 - 7/15/2016 (14 Days)
Progress 5/11/2016 - 5/24/2016 (14 Days)

AA 7/2/2016
7-2-2016- -7/15/2016
7-15-2016(14
(14Days) B
B 5/11/2016
5-11-2016--5/24/2016
5-24-2016(14
(14Days)
can be expanded to 90 days of pump and sensor information.
Days) Days)
Percentile comparison 25-75% 0-90% Average A

2 25-75% 0-90% Average AA

22.2
Percentile
Percentilecomparison
comparison 25-75% 0-90% Average
22.2
22.2 11.1
16.7
10.0 Range B
16.7

Range B is an optional, customisable time period that can reflect dates of the last evaluation period or office
16.7

11.1

visit. This period is used as a reference point for evaluating therapeutic progress and is shown in orange.
10.0
11.1
11.1
10.0
10.0
3.9
3.9 mmol/L 2.2 The dates default to 30 days prior to Range A and can contain up to 30 days of pump and sensor data for
24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
comparison purposes. This is an optional reporting period and is recommended to review different reporting
mmol/L 2.2
3.9
3.9
24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
mmol/L
mmol/L2.2
2.2
2424 11 22 33 44 55 66 77 88 99 10
10 11
11 12 15 16 17 18 19 20 21 22 23 24
A 20 10 15 13 14 15 16 17 18 1719 20 21 22 23
20 24
A periods
20 between Manual Mode vs SmartGuard
10 ™
Auto Mode. 15 17
Carb Ratio

Carb
(g/U) *
Carb RatioB
Ratio
AA 20.0
20 12 10
10.0 18 15
15.0 17
1717.0 20
20.0
20 Carb Ratio
(g/U) **
(g/U) (g/U) *
BB
Hypoglycemic patterns(2)
20
20.0 12
12.0 18
18.0
Hyperglycemic patterns(2)
17
17.0 20
20.0
B 20 12 18 17

2 PERCENTILE
A Hypoglycemic
Hypoglycemicpatterns(2)
patterns(2) Hyperglycemic patterns(2)
AA 1 7:21 - 8:31
(1 occurrences)
2 17:04 - 17:34
(1 occurrences)
3 8:00 - 9:45 4 18:40 - 20:15
Hypoglycemic patterns(2) COMPARISON
Assessment and Progress CHART Hyperglycemic patterns(2)
11 7:21
3
7:21- -8:31
8:31
22 17:04
17:04--17:34
17:34
3 8:00 - 9:45 44 18:40
18:40 -- 20:15
20:15 7-2-2016 - 7-15-2016 (14 Days) B 5-11-2016 - 5-24-2016 (14 Days)
A
(1 occurrences)
(1 occurrences) (1 occurrences)
(1 occurrences)
A
A B Auto Mode Exits A B Statistics A B 25-75% 0-90% Average A
7:21 - 8:31 17:04
Percentile comparison - 17:34
AA BB Auto Mode
Auto Mode Exits
Exits A
A B Statistics AA BB 1 22.2 2 3 8:00 - 9:45 4 18:40 - 20:15
4% 7% No Calibration •• 2 0 Auto Mode (per week) 96% (6d 18hrs) 0% (0hrs) (1 occurrences) (1 occurrences)
4%
4% 7%
7%
17% NoCalibration
High
No Calibration
SG Auto Mode •• 2
2
0 0
0
Auto Mode
Mode
Manual (per
(per
Mode week)
week)
(per week) 96%
96%(6d
4%18hrs)
(6d 18hrs)
(6hrs) 0%
0%(0hrs)
(0hrs)
100% (7d 00hrs)
20% Exit
HighSG SGAuto
AutoMode
Mode 16.7
17%
17% High Manual Mode (per
Mode (per
Sensor Wear week)
(per week)
week) 4%
4%(6hrs)
95% (6d (6hrs)
16hrs) 100% (7d
100%(6d
95% 00hrs)
(7d16hrs)
00hrs)
20% Auto
Exit Mode max 00 0
20% Exit 0 0
delivery
AutoMode
Modemax
max Sensor
AverageWear
SG ±(per
Wear SD week)
(per week) 95%
95%
8.3 (6d
± 2.8 16hrs)
(6dmmol/L
16hrs) 95%
95%±(6d
8.3 3.016hrs)
(6d 16hrs)
mmol/L
Auto
Auto Mode min 00 0
delivery
A B A
range

Auto Mode Exits A B Statistics

delivery 0 0 Average SG
SG ±± SD
SD 8.3
8.3 ±±2.8
2.8mmol/L
mmol/L 8.3
8.3±±3.0
3.0mmol/L
mmol/L
delivery Estimated A1C 6.8% 6.8% 11.1
AutoMode
Auto Modemin
min
range

10.0
in range

BG required for Auto 00 0 Estimated A1C

A1C 6.8%
6.8% 6.8%
6.8%
delivery
delivery
Mode • 1 0 Average BG 9.7 ± 4.1 mmol/L 8.1 ± 3.4 mmol/L
BGrequired
BG requiredfor
forAuto
Auto
• 4% 7%
Assessment and Progress
••
11 0
in

77%
Sensor
Mode Algorithm
Mode
Underread
0 0 Average BG
BG
BG / Calibration (per day) 9.7
9.7 ±±4.1
4.1mmol/L
mmol/L
7.8 / 4.1 8.1
8.1±±3.4
10.2 3.8mmol/L
/3.4 mmol/L
No Calibration
A 7-2-2016 - 7-15-2016 (14 Days) B 2
5-11-2016 - 5-24-2016 (14 Days) 0 Auto Mode (per week) 96% (6d 18hr
Time

SensorAlgorithm
Algorithm
in

70% Sensor BG
BG // Calibration
Calibration (per
(per day) 7.8
7.8//4.1 10.2
10.2/ /3.8 3.9
77%
77% Underread 00 00 day) 4.1 3.8
Underread
Sensor Updating 0 0 Total daily dose (per day) 23 units 18 units
Time

3 High4 SG Auto Mode Manual Mode (per week) 4% (6hr

mmol/L 2.2
Time

70%
70%
Sensor Updating 20 00 Total daily dose (per day) 23 units 18 units 17% 24 1 2
Percentile comparison
5 6 7 8 9 10
0
11 12
0 13 25-75% 14 15 16 0-90%
17 18 19 20 21 22 Average
23 A24
Sensor
No Updating
SG values •• 0 Total daily dose (per
Bolus amount (per day) day) 23 units
14U (61%) 18 units
9U (49%)
22.2 20% Exit
NoSG
SGvalues
values •• 22 00 Bolus amount (per day) 14U
9U(61%) 9U
9U(49%) A 20.0 10.0 15.0 17.0 20.0
No
Sensor Expired 0 BolusBasal
Auto amount (peramount
/ Basal day) (per day) 14U (61%)
(39%) (49%)
(51%) Carb Ratio
(g/U) *
B Auto Mode max
20.0 12.0 18.0
Sensor
17.0
Wear (per week) 20.0
95% (6d 16hr
Sensor Expired 00 00 Auto Basal
Basal // Basal
Basal amount
amount (per
(per day) 9U
9U(39%) 9U
9U(51%)
Sensor
Auto Expired
Mode disabled by
• 1 0
Auto
Set Change day) (39%)
3 3 (51%)
0 0
user delivery Average SG ± SD 8.3 ± 2.8 mmol
There are different Auto distributions
Mode min highlighted to indicate 50th percentile range (solid blue & orange bands) and
AutoMode
Modedisabled
disabled by
by Set 3.93 4.1
2% 3% Auto • Set Change
Change 16.7
• ••
11 00 Reservoir Change 3 Hypoglycemic patterns(2) Hyperglycemic patterns(2)
user
user
Alarms 2 0
2% 3%
3% Reservoir 3.93 4.1
2% Reservoir Change

Time in range
Change 3 A
Alarms
•• •• 2 0 0 0
90th10.0percentile range (single blue & dotted orange lines). Assess 3 8:00 - 9:45 for the degree ofEstimated
variabilityA1C between both
Meal (per day) 7.0 5.5
2.2 2.8 3.9 10.0 13.3 22.2 mmol/L Pump
Alarms
user
Suspend by 2
0 0
0
Meal 7.0 5.5 1 7:21 - 8:31
delivery
2 17:04 - 17:34
4 18:40 - 20:15 6.8
2.2 3.0 3.9 10.0 13.3
13.3 22.2
22.2 mmol/L
mmol/L Pump Suspend
Suspendby Meal (per
Carbs(per day)
day) (per day)
entered 7.0
166 ± 42g 5.5 ± 28g
140
11.1
(1 occurrences) (1 occurrences)
2.2 2.8 3.9 10.0 Pumptime/date
Large by user 00 00
user
BG required for Auto
periods for progress and improvement; a decreased • 1level0of variability is desired. Average BG
0 0 166
change Carbs
Carbs entered
entered (per
(per day)
day) 166±±42g
42g 140
140±±28g
28g
Large time/date Active Insulin time 3:00 hrs 3:00 hrs
9.7 ± 4.1 mmol
4 5 6
Auto Mode Warm Up 0 0
* Most recent pump settings are displayed
Unidentified
change •• 0
2 0
2 •• Active
Active Insulin
Insulin time
time 3:00
3:00hrs
hrs 3:00
3:00hrs
hrs
Mode
•• •• •• ••
* Most recent pump settings are displayed
A B Auto Mode Exits A B Statistics A B
Unidentified 22 22
* Most recent pump settings are displayed
Unidentified 3.9
Sensor Algorithm BG96% / Calibration (per day) 7.8 / 4
77% mmol/L 4% 2.2
24 1 2
7%
3Underread
4 5 No Calibration
6 7 8 9 • • 2 10 0 011
0
12 13 Auto
14 Mode
15 (per week)
16 17 18 (6d
19 18hrs)
20 210% (0hrs)
22 23 24
17%
A
70% 20.0
High SG Auto Mode
10.0 0 0 15.0
Manual Mode (per week)
17.0
4% (6hrs) 100% (7d 00hrs)
20.0
20% Exit
Carb Ratio
(g/U) *
B
Sensor
20.0
Updating Auto Mode max 12.0
0 018.0 Sensor Wear (per week) Total
95%daily
17.0
dose 95%
(6d 16hrs) (per(6dday)
16hrs)
20.0
23 uni
0 0
delivery

••
Average SG ± SD 8.3 ± 2.8 mmol/L 8.3 ± 3.0 mmol/L
No SG
Hypoglycemic patterns(2) values Auto Mode min 2 0
Hyperglycemic patterns(2) Bolus amount (per day) 14U (61%

Time in range
0 0 Estimated A1C 6.8% 6.8%
delivery
A BG required for Auto
Sensor
2 Expired
• 1 0
0 03 Auto
9.7 ±Basal / Basal
8.1amount (per day) 9U (39%
APPLICATION OF METHODOLOGY
7:21 - 8:31 17:04Mode
- 17:34 Average BG 4.1 mmol/L ± 3.4 mmol/L
Carb77%Ratio settings are also Underread
highlighted below the graph in the same colors (peras
day)the reporting periods.
1 8:00 - 9:45 4 18:40 - 20:15
(1 occurrences) (1 occurrences)
Sensor Algorithm
0 0 BG / Calibration 7.8 / 4.1 10.2 / 3.8
Auto Mode disabled by Set Change
Correlate Acarb ratios with Sensor Updating excursions 0to•determine
glycaemic if the
Totalcarb ratio is appropriate for carbohydrates
70%
0 1 0
Using the Assessment & Progress report, assess the overall mean sensor glucose Buser
daily dose (per day) 23 units 18 units
2% 3% Auto Mode Exits A
•• 2 0
B Statistics
Reservoir
A
Change
B
consumed. Miscalculated
7% Carb Ratios
Expired can result
• •in2 exits
•00 2 from0 Auto Mode if/ Basal
theweek)
high (perglucose values
18hrs) persist(0hrs)for a
No SG values Bolus amount (per day) 14U (61%) 9U (49%)
0•
on the Percentile Comparison chart. Focus on the degree of glucose variability, and Alarms
4%
No Calibration
Sensor AutoBasal
Auto Mode (per amount day) 96% (6d
9U (39%) 0%(51%)
9U

taking note of the hypoglycaemic and hyperglycaemic patterns while correcting frequency of 2.2 2.8 3.9 10.0 prolonged
17%
13.3 22.2
2%
period.
mmol/L Pump20%
3%
HighMode
Auto
Suspend
Exit
user
SG Auto
by
Modeby
disabled
• 10 00
0 0
Manual
Set ChangeMode (per week)
Sensor Wear (per week)
Meal
4% (6hrs)
(per
3.9
day)
95% (6d 16hrs)
3.9
100% (7d 00hrs)
4.1
95% (6d 16hrs)
4.1
7
Reservoir Change
user Auto Mode max
Alarms •• 20 00

hypoglycaemia initially. Carbs entered (per

5.5 day) 166 ± 42
delivery Average SG ± SD 8.3 ± 2.8 mmol/L 8.3 ± 3.0 mmol/L
2.2 3.0 3.9 10.0 13.3
Large time/date
22.2 mmol/L Auto Mode minby user 00 00
Meal (per day) 7.0
Time in range
Pump Suspend
delivery 0 0 Estimated A1C 6.8% 6.8%
change Carbs entered (per day) 166 ± 42g 140 ± 28g

Assess time in range and identify hypoglycaemic time in range greater than 3%. Make
BG required for Auto
Auto Mode Warm
Mode
Up • 01 00
Average BG Active Insulin
9.7 ± 4.1 mmol/L time8.1 ± 3.4 mmol/L 3:00 h
* Most recent pump settings are displayed * Most recent pump settings are displayed
UnidentifiedUnidentified
Sensor Algorithm • • 20•• 20 • 2• 2 •• Active Insulin time
BG / Calibration (per day)
3:00 hrs 3:00 hrs
7.8 / 4.1 10.2 / 3.8
adjustments in insulin to carb ratio or active insulin time if needed. Assess Auto Mode exit
77% Underread
70%
Sensor Updating 0 0 Total daily dose (per day) 23 units 18 units

frequency, Statistics for time in Auto Mode, sensor wear time, blood glucose (BG) levels, No SG values •• 2 0 Bolus amount (per day) 14U (61%) 9U (49%)

calibrations and basal / bolus percentage. All should be assessed for appropriateness.
Sensor Expired 0 0 Auto Basal / Basal amount (per day) 9U (39%) 9U (51%)
Auto Mode disabled by Set Change 3.9 4.1
user • 1 0
2% 3% Reservoir Change 3.9 4.1
Alarms •• 2 0
2.2 3.0 3.9 10.0 13.3 22.2 mmol/L Meal (per day) 7.0 5.5
Pump Suspend by user 0 0
Carbs entered (per day) 166 ± 42g 140 ± 28g
Auto Mode Warm Up 0 0
Active Insulin time 3:00 hrs 3:00 hrs
* Most recent pump settings are displayed
Unidentified •• 2 2 ••
 11.1
10.0

CARELINK™ SYSTEM INSIGHTS FOR SMARTGUARD™ CARELINK™ SYSTEM INSIGHTS FOR SMARTGUARD™
AUTO MODE – ASSESSMENT & PROGRESS REPORT AUTO MODE – ASSESSMENT & PROGRESS REPORT
3.9
Assessment and Progress
Assessment and Progress mmol/L 2.2
18 A A Days)
7/2/2016 - 7/15/2016 (14 B 5/11/2016
7-2-2016 - 7-15-2016 - 5/24/2016B(14 5-11-2016
(14 Days) Days) - 5-24-2016 (14 Days) 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
1924
25-75% 0-90%
25-75% 0-90% Average A Average A
Percentile comparison
22.2
Percentile comparison
22.2
Carb Ratio
A 20.0 10.0 15.0 17.0 20.0
(g/U) *
B 20.0 12.0 18.0 17.0 20.0
16.7 16.7

11.1
10.0
11.1
10.0
Hypoglycemic patterns(2) Hyperglycemic patterns(2)

5 AUTO MODE EXIT REASONS

A
3 HYPOGLYCAEMIC/HYPERGLYCAEMIC EPISODES
Assessment and Progress Assessment and Progress
Assessment
AAssessment and
andProgress B Assessment
AAssessment and
andProgress B
1 1
7/2/2016 - 7/15/2016 (14 Days)
Progress 5/11/2016 - 5/24/2016 (14 Days) 7/2/2016 - 7/15/2016 (14 Days)
Progress 5/11/2016 - 5/24/2016 (14 Days)


AA B AA B

Assessment and Progress

7-2-2016
7-2-2016- -7-15-2016
7-15-2016(14
(14Days)
Days) B 5-11-2016
5-11-2016 -- 5-24-2016
5-24-2016 (14
(14 Days)
Days) 7-2-2016
7-2-2016- -7-15-2016
7-15-2016(14
(14Days)
Days) B 5-11-2016
5-11-2016 -- 5-24-2016
5-24-2016 (14
(14 Days)
Days)
Average A Average A

7:21 - 8:31 17:04 - 17:34

Percentile comparison 25-75% 0-90% Percentile comparison 25-75% 0-90%

2 Average AA
2 Average AA

1 2 3 4
22.2
Percentile 25-75%
25-75% 0-90%
0-90% Average 22.2 25-75%
25-75% 0-90%
0-90% Average
Percentilecomparison
comparison Percentile
Percentilecomparison
comparison

AND DURATION A
8:00 - 9:45 18:40 - 20:15
22.2 22.2
3.9 3.9
22.2 22.2

(1 occurrences) (1 occurrences)
16.7 16.7

mmol/L 2.2 mmol/L 2.2

B14 17 5-11-201616 19- 5-24-2016
18 21 (14 Days)
16.7 16.7

7-2-2016
8 11 - 7-15-2016 (14
11 14 Days)
16.7 16.7

24 1 2 24 3 1 4 2 5 3 6 4 7 5 8 6 9 7 10 9 12 10 13 12 15 13 16 15 18 17 20 19 22 20 23 21 24 22 11.1
10.0 23 24 11.1
10.0
11.1
11.1 11.1
11.1
10.0
10.0 10.0
10.0

Carb Ratio
A Carb Ratio
A 20 20.0 10 10.0 15 15.0 17 17.0 20 mmol/L 2.2
3.9
3.9
3.9
20.0 mmol/L 2.2
3.9
3.9
3.9

24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

(g/U) * (g/U) *
mmol/L
mmol/L2.2
2.2 mmol/L
mmol/L2.2
2.2

B B 20 20.0 12 12.0 18 18.0 17 17.0 20 20.0

2424 11 22 33 44 55 66 77 88 99 10
10 11
11 12 15 16 17 18 19 20 21 22 23 2424 2424 11 22 33 44 55 66 77 88 99 10 11 12 15 16 17 18 19 20 21 22 23 2424
15 13 14 15 16 17 18 1719 20 21 22 23

A
10 11 15 13 14 15 16 17 18 1719 20 21 22 23

Average
Carb Ratio
A 20 10 20 A 20 10 20

25-75% 0-90%
Carb Ratio
(g/U) * (g/U) *
RatioB
AA 20.0
20.0
20 12 10.0
10.0 18 15.0 17.0
1717.0 20.0
20.0
20 RatioB
AA 20.0
20.0
20 12 10.0
10.0 18 15.0 17.0
1717.0 20.0
20.0
20

Percentile comparison
Carb
CarbRatio Carb
CarbRatio
(g/U) **
(g/U) (g/U) **
(g/U)
BB 20.0
20.0 12.0
12.0 18.0 17.0
17.0 20.0
20.0 BB 20.0
20.0 12.0
12.0 18.0 17.0
17.0 20.0
20.0
Hypoglycemic patterns(2) Hyperglycemic patterns(2) Hypoglycemic patterns(2) Hyperglycemic patterns(2)
A Hypoglycemic
Hypoglycemicpatterns(2) Hyperglycemic patterns(2) A Hypoglycemic
Hypoglycemicpatterns(2) Hyperglycemic patterns(2)
Hypoglycemic patterns(2) Hyperglycemic patterns(2)
patterns(2) patterns(2)
Hypoglycemic patterns(2) Hyperglycemic patterns(2)
A B
1 7:21 - 8:31 2 17:04 - 17:34 1 7:21 - 8:31 2 17:04 - 17:34

A
AA 3 4 18:40 - 20:15 AA 3 4 18:40 - 20:15

Auto Mode Exits Statistics

8:00 - 9:45 8:00 - 9:45

22.2
A B B3
(1 occurrences) (1 occurrences) (1 occurrences) (1 occurrences)
11 7:21
3
7:21- -8:31
8:31
(1 occurrences)
22 17:04
17:04--17:34
17:34
(1 occurrences)
3 8:00 - 9:45 44 18:40
18:40 -- 20:15
20:15 11 7:21
7:21- -8:31
8:31
(1 occurrences)
22 17:04
17:04--17:34
17:34
(1 occurrences)
3 8:00 - 9:45 44 18:40
18:40 -- 20:15
20:15
(1 occurrences) (1 occurrences) (1 occurrences) (1 occurrences)

A A A B Auto Mode Exits A B Statistics A B A B Auto Mode Exits A B Statistics A B

7:21 - 8:31
2 17:04 - 17:34
7:21 - 8:31 17:04 - 17:34 4% AA BB Auto Mode
Auto Mode Exits
Exits A
A B Statistics AA BB 4% AA BB Auto Mode
Auto Mode Exits
Exits A
A B Statistics AA BB

1 1 2 3 3 8:00 -49:45 4
7% No Calibration •• 2 0 Auto Mode (per week) 96% (6d 18hrs) 0% (0hrs) 7% No Calibration •• 2 0 Auto Mode (per week) 96% (6d 18hrs) 0% (0hrs)
8:00 - 9:45 18:40 - 20:15 18:40 - 20:15 4%
4% 7%
7%
•• 22 Auto Mode (per week) 96%
96%(6d
4%18hrs)
(6d 18hrs) 0%
0%(0hrs)
(0hrs)
4%
4% 7%
7%
•• 22 Auto Mode (per week) 96%
96%(6d
4%18hrs) 0% (0hrs)
(1 occurrences) (1 occurrences)
Mode (per week) Mode (per week) (6d 18hrs) 0% (0hrs)
(1 occurrences) (1 occurrences)
17% NoCalibration
High
No Calibration
SG Auto Mode 0 Manual Mode (per week) (6hrs) 100% (7d 00hrs) 17% NoCalibration
High
No Calibration
SG Auto Mode 0 Manual Mode (per week) (6hrs) 100% (7d 00hrs)
0 0 0 0

4%
20% Exit
HighSG SGAuto
AutoMode
Mode 20% Exit
HighSGSGAuto
AutoMode
Mode
17%
17% High Manual Mode
Sensor Wear (per
Mode (per week)
(per week)
week) 4%
4%(6hrs)
95% (6d (6hrs)
16hrs) 100% (7d
100%(6d
95% 00hrs)
(7d16hrs)
00hrs) 17%
17% High Manual Mode (per
Mode (per
Sensor Wear week)
(per week)
week) 4%
4%(6hrs)
95% (6d (6hrs)
16hrs) 100% (7d
100%(6d
95% 00hrs)
(7d16hrs)
00hrs)
00 0 00 0

7%
••
20%
20% Auto
Exit Mode max
Exit 20%
20% Auto
Exit Mode max
Exit
0 0 0 0
delivery Sensor
AverageWear
SG ±(per
SD week) 95% (6d 16hrs) 95%
95%±(6d
3.016hrs) delivery Sensor
AverageWear
SG ±(per
SD week) 95% (6d 16hrs) 95%
95%±(6d
3.016hrs)

96% (6d 18hrs) 0% (0hrs)

Wear (per week) 95% (6dmmol/L
16hrs) (6d 16hrs)

Auto Mode (per week)

AutoMode
Modemax
max 8.3 ± 2.8 8.3 mmol/L Wear (per week) 95%
8.3 (6dmmol/L
± 2.8 16hrs) 8.3 (6d 16hrs)
mmol/L

2 0
Auto AutoMode
Auto Modemax
max

No Calibration
Auto Mode min
delivery 00 0 Auto Mode min
delivery 00 0

range

range
delivery 0 0 Average SG
SG ±± SD
SD 8.3
8.3 ±±2.8
2.8mmol/L
mmol/L 8.3
8.3±±3.0
3.0mmol/L
mmol/L delivery 0 0 Average SG
SG ±± SD
SD 8.3
8.3 ±±2.8
2.8mmol/L
mmol/L 8.3
8.3±±3.0
3.0mmol/L
mmol/L
delivery Estimated A1C 6.8% 6.8% delivery Estimated A1C 6.8% 6.8%
AutoMode
Auto Modemin
min AutoMode
Auto Modemin
min

range

range
in range

in range
BG required for Auto 00 0 Estimated A1C 6.8% 6.8% BG required for Auto 00 0 Estimated A1C 6.8% 6.8%
delivery
delivery
Mode
BGrequired
requiredfor
forAuto
Auto
• 1 0 Average BG
A1C 6.8%
9.7 ± 4.1 mmol/L
6.8%
8.1 ± 3.4 mmol/L
delivery
delivery
Mode
BGrequired
requiredfor
forAuto
Auto
• 1 0 Average BG
A1C 6.8%
9.7 ± 4.1 mmol/L
6.8%
8.1 ± 3.4 mmol/L
BG BG
• 11 00 • 11 00

in

in
Sensor
Mode Algorithm
Mode Average
Average BG
BG
BG / Calibration (per day) 9.7
9.7 ±±4.1
4.1mmol/L
mmol/L
7.8 / 4.1 8.1
8.1±±3.4
10.2 3.8mmol/L
/3.4 mmol/L Sensor
Mode Algorithm
Mode Average
Average BG
BG
BG / Calibration (per day) 9.7
9.7 ±±4.1
4.1mmol/L
mmol/L
7.8 / 4.1 8.1
8.1±±3.4
10.2 3.8mmol/L
/3.4 mmol/L
77% 0 0 77% 0 0

B16.7A
Underread Underread

Time
SensorAlgorithm
Algorithm

Time
SensorAlgorithm
Algorithm

in

in
A B Mode Exits Auto Mode Exits
Sensor Sensor

A A
70% BG
BG // Calibration
Calibration (per
(per day) 7.8
7.8//4.1 10.2
10.2/ /3.8 70% BG
BG // Calibration
Calibration (per
(per day) 7.8
7.8//4.1 10.2
10.2/ /3.8

Auto A B A B Statistics Statistics B B

77%
77% Underread 00 00 day) 4.1 3.8 77%
77% Underread 00 00 day) 4.1 3.8
Underread
Sensor Updating 0 0 Total daily dose (per day) 23 units 18 units Underread
Sensor Updating 0 0 Total daily dose (per day) 23 units 18 units

Time

Time
High SG Auto Mode

Time

Time
70% 70%

Manual Mode (per week) 4% (6hrs) 100% (7d 00hrs)

70% 70%

17%
Sensor
Sensor
No Updating
Updating
SG values •• 00
2 00 Total
Total daily
Bolus daily dose
dose
amount (per
(per
(per day)
day)
day) 23
23units
14U units
(61%) 18
18units
9U units
(49%) Sensor
Sensor
No Updating
Updating
SG values •• 00
2 00 Total
Total daily
Bolus daily dose
dose
amount (per
(per
(per day)
day)
day) 23
23units
14U units
(61%) 18
18units
9U units
(49%)

0 0
NoSG
No SGvalues
Sensor values
Expired •• 22
0 00 Bolus
Auto amount
BolusBasal
amount (per day)
(peramount
/ Basal day) (per day) 14U
9U(61%)
14U (61%)
(39%) 9U
9U(49%)
(49%)
(51%) NoSG
No SGvalues
Sensor values
Expired •• 22
0 00 Bolus amount
BolusBasal
Auto amount (per day)
(peramount
/ Basal day) (per day) 14U
9U(61%)
14U (61%)
(39%) 9U
9U(49%)
(49%)
(51%)

4% 4% 7% 7% •• 2 ••
Sensor
Auto
Sensor Expired
Mode disabled by
Expired 00 00 Auto
Auto Basal
Basal // Basal
Basal amount
amount (per
(per day)
day) 9U
9U(39%)
(39%)3 9U
9U(51%)
3 (51%) Sensor
Auto
Sensor Expired
Mode disabled by
Expired 00 00 Auto
Auto Basal
Basal // Basal
Basal amount
amount (per
(per day)
day) 9U
9U(39%)
(39%)3 9U
9U(51%)
3 (51%)

20%
Set Change Set Change
• •
0 2 0 Auto Mode (per week) Auto Mode (per96% (6d 18hrs)
week) 0% (0hrs)
96% (6d 18hrs) 0% (0hrs)
Exit
1 0 1 0
No Calibration No Calibration 2%
2%
3%
3%
user
AutoMode
Auto
user
user
Alarms
Modedisabled
disabled by
by
• ••
• 11
2
00
0
Set
Set Change
Change
Reservoir Change
3.9
3.9
3 4.1
4.1
3 2%
2%
3%
3%
user
AutoMode
Auto
user
user
Alarms
Modedisabled
disabled by
by
• ••
• 11
2
00
0
Set
Set Change
Change
Reservoir Change
3.9
3.9
3 4.1
4.1
3

These11.1patterns are determined by the duration of an episode lasting at

2% 3% Reservoir
Reservoir Change
Change 3.9
3.9 4.1
4.1 2% 3% Reservoir
Reservoir Change
Change 3.9
3.9 4.1
4.1
Alarms
•• •• 2 0 Alarms
•• •• 2 0

Sensor Wear (per week) 95% (6d 16hrs) 95%6 (6d 16hrs)
2.2 2.8 3.9 10.0 13.3 22.2 mmol/L Pump
AlarmsSuspend by 2 0 Meal (per day) 7.0 5.5 2.2 2.8 3.9 10.0 13.3 22.2 mmol/L Pump
AlarmsSuspend by 2 0 Meal (per day) 7.0 5.5
High SG Auto Mode High SG Auto Mode
0 0 0 0
17% 17% 0 0 0 0 Manual Mode (per week) 4% (6hrs)
Manual Mode (per week) 100% (7d 00hrs)
4% (6hrs) 100% (7d 00hrs) 2.2
2.2 3.0
3.0 3.9
3.9 10.0 13.3
10.0 13.3 22.2
22.2 mmol/L
mmol/L user
Pumptime/date
Pump
Large Suspendby
Suspend by user
user 00 00
Meal
Meal (per
Carbs(per day)
day) (per day)
entered 7.0
7.0
166 ± 42g 5.5
5.5 ± 28g
140 2.2
2.2 3.0
3.0 3.9
3.9 10.0 13.3
10.0 13.3 22.2
22.2 mmol/L
mmol/L user
Pumptime/date
Pump
Large Suspendby
Suspend by user
user 00 00
Meal
Meal (per
Carbs(per day)
day) (per day)
entered 7.0
7.0
166 ± 42g 5.5
5.5 ± 28g
140

Auto Mode max

0 0 Carbs 0 0
Carbs entered
entered (per
(per day) 166
166±±42g 140
140±±28g Carbs
Carbs entered
entered (per
(per day) 166
166±±42g 140
140±±28g
20% Exit 20% Exit
change day) 42g 28g change day) 42g 28g
Active Insulin time 3:00 hrs 3:00 hrs Active Insulin time 3:00 hrs 3:00 hrs
4 5 6 4 5
AutoMode
Auto ModeWarm
Warm Up
Up 00 00 AutoMode
Auto ModeWarm
Warm Up
Up 00 00
* Most recent pump settings are displayed
•• 2 2 •• * Most recent pump settings are displayed
•• ••

0 0
Unidentified Active Unidentified 2 2
Active Insulin
Insulin time 3:00
3:00hrs 3:00
3:00hrs Active
Active Insulin
Insulin time 3:00
3:00hrs 3:00
3:00hrs
Sensor Wear (per week) 95%
Sensor Wear (per (6d 16hrs)
week) 95%
95%(6d
(6d16hrs)
16hrs) 95% (6d 16hrs)
time hrs hrs time hrs hrs
•• •• •• •• •• •• •• ••
* Most recent pump settings are displayed * Most recent pump settings are displayed
Unidentified 22 22 Unidentified 22 22
* Most recent pump settings are displayed * Most recent pump settings are displayed
Unidentified Unidentified
Auto Mode max Auto Mode max
0 0 0 0
delivery
least 10.0 30 minutes. The pattern is highlighted in this section below the Average SG ± SD 8.3 ± 2.8 mmol/L 8.3 ± 3.0 mmol/L
delivery delivery Average SG ± SD Average SG ±8.3
SD± 2.8 mmol/L 8.3±±2.8
8.3 3.0mmol/L
mmol/L 8.3 ± 3.0 mmol/L
Auto Mode min Auto Mode min
Time in range

Time in range

0 0 0 0
delivery delivery Estimated A1C Estimated A1C 6.8% 6.8% 6.8% 6.8% Auto Mode min

Time in range
0 0
comparison chart. These patterns will only apply to Period A. Each pattern recognised is labeled on the graph Estimated A1C 6.8% 6.8%
BG required for Auto BG required for Auto
• Mode Mode • 1 0 1 0 Average BG Average BG 9.7 ± 4.1 mmol/L 8.1±±4.1
9.7 3.4mmol/L
mmol/L 8.1 ± 3.4 mmol/L delivery
Sensor Algorithm Sensor Algorithm BG / Calibration (per day) 7.8 / 4.1
BG / Calibration (per day) 10.2 / 3.87.8 / 4.1 10.2 / 3.8
0 0 0 0
BG required for Auto
•
77% 77% Underread Underread

tommol/L
the2.2corresponding numbered Hypoglycaemic or Hyperglycaemic Pattern. A hypoglycaemic pattern is 1 0
3.9 70% 70%
Sensor Updating Sensor Updating0 0 0 0 Total daily dose (per day) 23 units
Total daily dose (per day) 18 units23 units 18 units Mode Average BG 9.7 ± 4.1 mmol/L 8.1 ± 3.4 mmol/L
•• •• No SG values No SG values 2 0 2 0 14U (61%)
Bolus amount (per day)Bolus amount (per day) 9U (49%)
14U (61%) 9U (49%)
Sensor Algorithm
identified 24
when
1
the2 SG falls
3
below
4
the
5
low6 limit for
7
Sensor Expired
at 8least 30
9
minutes.
10 11
A hyperglycaemic
Sensor Expired 0
12
Auto Mode disabled by Auto Mode disabled by
13
0
14
pattern
15
is16 based
0
17
0
on 18 Auto Basal / Basal amount (per
Auto 9U (39%)
day)/ Basal amount
Basal (per day) 9U (51%)
9U (39%) 9U (51%)
77%
19 20 21 22 23 24
Underread
0 0 BG / Calibration (per day) 7.8 / 4.1 10.2 / 3.8
20.070%
Set Change Set Change 3 3 3.9 4.1
• •
the magnitude of AUC (Area • • Under•the Curve) above target.
1 0 1 0
2% Carb Ratio
A 2%
20.03%
user
3% 10.0 user 15.0
Reservoir Change Reservoir Change 3 3 3.9 4.1
17.0
(g/U) * • Alarms Alarms 2 0 2 0 Sensor Updating 0 0 Total daily dose (per day) 23 units 18 units
2.2 2.8 3.9 10.0 13.3
2.2 22.2
3.0 B3.9
mmol/L10.0 Pump22.2
13.3 Suspend by
mmol/L 20.0 Meal (per day) 12.0Meal (per day) 7.0 5.5 7.0 18.0
5.5 17.0 20.0
••
user Pump Suspend 0 0
by user 0 0
Large time/date
0 Up 0
Auto Mode Warm 0 0
Carbs entered (per day) 166 ± 42g
Carbs entered (per day) 140 ± 28g
166 ± 42g 140 ± 28g No SG values 2 0 Bolus amount (per day) 14U (61%) 9U (49%)
Hypoglycemic patterns(2)
change
Active Insulin time Active Insulin time 3:00 hrs 3:00 hrs3:00 hrs Hyperglycemic
3:00 hrs patterns(2)
•• •• •• •• Sensor Expired 0 0 Auto Basal / Basal amount (per day) 9U (39%) 9U (51%)
* Most recent pump settings are displayed
* Most recent pump settings are displayed
Unidentified Unidentified 2 2 2 2
A

4
Auto Mode disabled by 3.9 4.1
TIME IN RANGE
7:21 - 8:31 17:04 - 17:34 Set Change
1
(1 occurrences)
2
(1 occurrences)
3 8:00 - 9:45 4 18:40 - 20:15
user • 1 0
2% 3% Reservoir Change 3.9 4.1
Alarms •• 2 0
A B
Time in Range comparesAbothBperiods side by side
Auto Mode Exits
to show progress in
Statistics 2.2 3.0 A 3.9 10.0 B 13.3 22.2 mmol/L Meal (per day) 7.0 5.5
Pump Suspend by user 0 0
4% 7%
glucose management and the amount of time the patient has spent Carbs entered (per day) 166 ± 42g 140 ± 28g
No Calibration •• 2 0 Auto Mode (per week) 96% (6d 18hrs) 0% (0hrs)
Auto Mode Warm Up 0 0
17% within
High a Mode
SG Auto certain glucose range. Percentage is based on average
Manual sensor
Mode (per week) 4% (6hrs) 100% (7d 00hrs) Active Insulin time 3:00 hrs 3:00 hrs
0 0
20%
values
Exit
for that range and time period. Each section of
Sensorthe bar
Wear graph
(per week) is
* Most recent pump settings are displayed
95% (6d 16hrs) 95% (6d 16hrs)
Unidentified •• 2 2 ••
Auto Mode max
0 0
divided into ranges:
delivery
Auto Mode min
Average SG ± SD 8.3 ± 2.8 mmol/L 8.3 ± 3.0 mmol/L
Time in range

0 0 Estimated A1C 6.8% 6.8%

delivery
Gold: 13.9 - 22.2 mmol/L
BG required for Auto
• 1 (251-400 mg/dL)
Mode
0 Average BG 9.7 ± 4.1 mmol/L 8.1 ± 3.4 mmol/L Use this table to assess reasons a patient can exit Auto Mode. Some of the exit reasons may be due to behaviour
77% Underread Gold bars: 10.0 - 13.9 mmol/L
Sensor Algorithm
0 0 (181-250 mg/dL)
BG / Calibration (per day) 7.8 / 4.1 10.2 / 3.8
patterns; addressing these exits may help patients avoid unintended Auto Mode exits.
Green: 3.9-10.0 mmol/L
70%
Sensor Updating
(70-180 mg/dL) 0 0 Total daily dose (per day) 23 units 18 units
For example, if a patient has exited Auto Mode due to Missed Calibration, coach the patient regarding calibration
No SG values •• 2 0 Bolus amount (per day) 14U (61%) 9U (49%)
Sensor ExpiredRed bars: 3.0 - 3.9 mmol/L
0 0(54-69 mg/dL) Auto Basal / Basal amount (per day) 9U (39%) 9U (51%) behaviours and best practices. Encourage the patient to enter calibrations when prompted by the system and

Red: < 3.0 mmol/L (54• mg/dL) before bedtime to avoid missing a calibration during sleep.
Auto Mode disabled by Set Change 3.9 4.1
1 0
user
2% 3% Reservoir Change 3.9 4.1
Alarms •• 2 0
2.2 3.0 When assessing time in 0range
3.9 10.0 13.3
0
address hypoglycaemia
22.2 mmol/L first. If there
Meal (per day) 7.0 5.5
Pump Suspend by user
is any time <3.0 mmol/L (54 mg/dL) or time <3.9 mmol/L
Carbs (70day)
entered (per mg/dL) 166 ± 42g 140 ± 28g
Auto Mode Warm Up 0 0
is 3% or greater consider changing carb ratios and/or active insulin
Active Insulin time 3:00 hrs 3:00 hrs
* Most recent pump settings are displayed
Unidentified •• 2 2 ••
time as mentioned in the methodology. Follow this over time to be sure hypoglycaemia isn’t increasing as the
patient gets into better glucose control.
 CARELINK™ SYSTEM INSIGHTS FOR SMARTGUARD™ CARELINK™ SYSTEM INSIGHTS FOR SMARTGUARD™
10 20 11 12
AUTO MODE – ASSESSMENT & PROGRESS REPORT
13 14 15 16 17 18 19 20 21 22 23 24
AUTO MODE – WEEKLY REVIEW REPORT 21
15.0 17.0 20.0
18.0 17.0 20.0

Hyperglycemic patterns(2)

6 STATISTICS4 REVIEWING SMARTGUARD™ AUTO MODE REPORTS FOR MINIMED™ 670G SYSTEM –
Assessment and Progress
Assessment
AAssessment and
andProgress B
1
7/2/2016 - 7/15/2016 (14 Days)
Progress 5/11/2016 - 5/24/2016 (14 Days)

AA 7-2-2016
7-2-2016- -7-15-2016
7-15-2016(14
(14Days)
Days) B
B 5-11-2016
5-11-2016 -- 5-24-2016
5-24-2016 (14
(14 Days)
Days)
25-75% 0-90% Average A

3
Percentile comparison

WEEKLY REPORT
2
8:00 - 9:45 18:40 - 20:15
22.2
Percentile 25-75%
25-75% 0-90%
0-90% Average AA
Average
Percentilecomparison
comparison
22.2
22.2

16.7

16.7
16.7

11.1
10.0
11.1
11.1
10.0
10.0

Use the Weekly Review report to evaluate glucose events and Auto Mode exits that occurred during the
3.9
mmol/L 2.2
3.9
3.9
24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
mmol/L
mmol/L2.2
2.2
2424 11 22 33 44 55 66 77 88 99 10
10 11
11 12 15 16 17 18 19 20 21 22 23 2424
Carb Ratio
A 20 10 15 13 14 15 16 17 18 1719 20 21 22 23
20
(g/U) *
Carb
Carb RatioB
Ratio
AA 20.0
20.0
20 12 10.0
10.0 18 15.0 17.0
1717.0 20.0
20.0
20

A
(g/U) **
(g/U)

A B Statistics B
BB 20.0
20.0 12.0
12.0 18.0 17.0
17.0 20.0
20.0

current reporting period (Period A) in 7 day intervals.

Hypoglycemic patterns(2) Hyperglycemic patterns(2)
A Hypoglycemic
Hypoglycemicpatterns(2)
patterns(2) Hyperglycemic patterns(2)
AA 1 7:21 - 8:31 2 17:04 - 17:34 3 8:00 - 9:45 4 18:40 - 20:15
(1 occurrences) (1 occurrences)
11 7:21
3
7:21- -8:31
8:31
(1 occurrences)
22 17:04
17:04--17:34
17:34
(1 occurrences)
3 8:00 - 9:45 44 18:40
18:40 -- 20:15
20:15
(1 occurrences) (1 occurrences)

A B Auto Mode Exits A B Statistics A B

4% AA BB Auto Mode
Auto Mode Exits
Exits A
A B Statistics AA BB

Auto Mode (per week) 96% (6d 18hrs) 0% (0hrs)

7%
••

2 0
No Calibration 2 0 Auto Mode (per week) 96% (6d 18hrs) 0% (0hrs)
4%
4% 7%
7%
17% NoCalibration
High
No Calibration
SG Auto Mode •• 22
0 0
0
Auto Mode
Mode
Manual (per
(per
Mode week)
week)
(per week) 96%
96%(6d
4%18hrs)
(6d 18hrs)
(6hrs) 0%
0%(0hrs)
(0hrs)
100% (7d 00hrs)
20% Exit
HighSG SGAuto
AutoMode
Mode
17%
17% High Manual Mode (per
Mode (per
Sensor Wear week)
(per week)
week) 4%
4%(6hrs)
95% (6d (6hrs)
16hrs) 100% (7d
100%(6d
95% 00hrs)
(7d16hrs)
00hrs)
20% Auto
Exit Mode max 00 0
20% Exit 0 0
delivery
AutoMode
Modemax
max Sensor
AverageWear
SG ±(per
Wear SD week)
(per week) 95%
95%
8.3 (6d 16hrs)
(6dmmol/L
± 2.8 16hrs) 95%
95%±(6d
8.3 3.016hrs)
(6d 16hrs)
mmol/L
Auto
Auto Mode min
delivery 00 0

range
delivery 0 0 Average SG
SG ±± SD
SD 8.3
8.3 ±±2.8
2.8mmol/L
mmol/L 8.3
8.3±±3.0
3.0mmol/L
mmol/L
delivery Estimated A1C 6.8% 6.8%

Manual Mode (per week) 4% (6hrs) 100% (7d 00hrs)

AutoMode
Auto Modemin
min

range
in range
BG required for Auto 00 0 Estimated A1C 6.8% 6.8%
delivery
delivery • 1 0 A1C 6.8% 6.8%

0 0
Mode Average BG 9.7 ± 4.1 mmol/L 8.1 ± 3.4 mmol/L
BGrequired
BG requiredfor
forAuto
Auto
• 11 00

in
Sensor
Mode Algorithm
Mode Average
Average BG
BG
BG / Calibration (per day) 9.7
9.7 ±±4.1
4.1mmol/L
mmol/L
7.8 / 4.1 8.1
8.1±±3.4
10.2 3.8mmol/L
/3.4 mmol/L
77% 0 0
Underread

Time
SensorAlgorithm
Algorithm

in
70% Sensor BG
BG // Calibration
Calibration (per
(per day) 7.8
7.8//4.1 10.2
10.2/ /3.8
77%
77% Underread 00 00 day) 4.1 3.8
Underread
Sensor Updating 0 0 Total daily dose (per day) 23 units 18 units

Time
Time
Weekly Review (1 of 2)
70%
70%
Sensor
Sensor Updating
Updating •• 00
2 00 Total
Total daily
Bolus daily dose
dose
amount (per
(per
(per day)
day)
day) 23
23units
14U units
(61%) 18
18units
9U units
(49%)

Sensor Wear (per week) 95% (6d 16hrs) 95% (6d 16hrs)
No SG values
NoSG
No SGvalues
Sensor values
Expired •• 22
0 00 Bolus amount
BolusBasal
Auto amount (per day)
(peramount
/ Basal day) (per day) 14U
9U(61%)
14U (61%)
(39%) 9U
9U(49%)
(49%)
(51%)
Sensor
Auto
Sensor Expired
Mode disabled by
Expired 00 00 Auto
Auto Basal
Basal // Basal
Set Change Basal amount
amount (per
(per day)
day) 9U
9U(39%)
(39%)3 9U
9U(51%)
3 (51%)
• 1 0

0 0 7-2-2016 - 7-8-2016
Review (7
(1 Days)
user
AutoMode
Modedisabled
disabled by
by 3.9 4.1
Set
Set Change
2% 3% Auto • Change 3.9 4.1
• ••
11 00 Reservoir Change 3 3
user

Weekly of 2)
2% 3% user
Alarms 2 0
2% 3% Reservoir
Reservoir Change
Change 3.9
3.9 4.1
4.1
2.2 2.8 3.9 10.0 13.3 22.2 mmol/L
Alarms
Pump
AlarmsSuspend by •• •• 22 00 Meal (per day) 7.0 5.5

Average SG ± SD 8.3 ± 2.8 mmol/L 8.3 ± 3.0 mmol/L

0 0
user Meal
2.2 3.0 3.9 10.0 13.3
13.3 22.2
22.2 mmol/L
mmol/L Meal (per
Carbs(per day)
day) (per day)
entered 7.0
7.0
166 ± 42g 5.5
5.5 ± 28g
140
00 00

1
2.2 3.0 3.9 10.0 Pumptime/date
Pump
Large Suspendby
Suspend by user
user
0 0 Carbs
change Carbs entered
entered (per
(per day)
day) 166
166±±42g
42g 140
140±±28g
28g

7-2-2016 - 7-8-2016 (7 Days)

Active Insulin time 3:00 hrs 3:00 hrs
4 5 6
AutoMode
Auto ModeWarm
Warm Up
Up 00 00
* Most recent pump settings are displayed
Unidentified •• 2 2 •• Active
Active Insulin
Insulin time
time 3:00
3:00hrs
hrs 3:00
3:00hrs
hrs
•• •• •• ••
* Most recent pump settings are displayed
Unidentified 22 22
* Most recent pump settings are displayed
Unidentified

0 0 Estimated A1C 6.8% 6.8%

22.2
1 0 Average BG 9.7 ± 4.1 mmol/L 8.1 ± 3.4 mmol/L
22.2

0 0 BG / Calibration (per day) 7.8 / 4.1 10.2 / 3.8 16.7

14.8
16.7
0 0 Total daily dose (per day) 23 units 18 units 14.8
11.4 11.4
11.1 10.8 10.5
9.8 10.2
9.5 8.4
2 0 Bolus amount (per day) 14U (61%) 9U (49%) 10.0
11.1 8.2
8.9 9.1 8.4 8.6 11.4
8.4
11.4
10.8 8.5
9.1
8.0 10.2 10.5
9.8 7.1 7.4 9.5 8.4
10.0 8.9 9.1 8.4 9.1
8.6 8.4 8.5
0 0 Auto Basal / Basal amount (per day) 9U (39%) 9U (51%) 7.1
8.2 8.0
4.8 7.4
3.9
3.9 2.8
1 0 Set Change 3.9 4.1 2.2
4.8
3.9
3.9
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 2.8 15 18 21 0 3 6 9 12 15 18 21 0
Reservoir Change 3.9 4.1 2.2
0
overnight 3breakfast
6 9lunch 12 15
dinner 18 21 overnight
0 3 6
breakfast 9 12
lunch 15 dinner
18 21 overnight
0 3 6
breakfast 9 12
lunch 15 dinner
18 21 0overnight3 6 9
breakfast 12
lunch 15 18
dinner 21 0
2 0 breakfast lunch dinner

Basal (U/hr)
overnight breakfast lunch dinner overnight overnight breakfast lunch dinner overnight breakfast lunch dinner

Meal (per day) 7.0 5.5

Basal (U/hr)
0 0
Carbs entered (per day) 166 ± 42g 140 ± 28g
0 0
Active Insulin time 3:00 hrs 3:00 hrs
2 2 •• Exit Reason Details
2 22.2
Exit Reason Details
1,5 - No Calibration
1,5 - No Calibration

The statistics table provides a comparison of the patient’s pump and sensor use, in addition to the amount of
22.2 Sensor was not calibrated (e.g. Calibration not
Sensor was
accepted, BGnotnotcalibrated
received,(e.g. Calibration not
No Calibration
accepted,etc.).
occurred, BG not received, No Calibration
occurred, etc.).

time spent in Auto Mode for both reporting periods.

16.7
16.7
13.4 13.2 13.3 2 - No SG values
13.4 13.2 13.3 12.2 2 - No SG values
12.2

Average BGs and calibrations per day are shown to display the consistency in the patient’s blood glucose checks
10.8 11.0 10.8 SG values were not available (e.g. Lost sensor
11.1 10.1 10.8 11.0 10.8 SG values weresensor,
not available
10.0 11.1 8.4 10.1 9.2 signal, Change Check(e.g. Lost sensor
connection,
10.0 8.4 9.2 signal, Change sensor, Checksignal
connection,
7.8 Transmitter depleted, Sensor not found,
7.2 Transmitter depleted, Sensor signal not found,

per day. It is recommended to test BG 3-4 times per day, or as requested by the system.
7.8 etc.).
6.4 7.2
5.6 6.4 6.0 etc.).
4.9 5.6 6.0
4.9
3.9 3 - Alarms
3.9 3 - Alarms

Review Total Daily Dose (TDD) and assess if it is appropriate for the patient’s weight and amount of insulin
2.2
0 2.23 6 9 12 15 18 21
0 3 6 9 12 15 18 210 03 36 69 9 12 1215 1518 18 21 21 0 0 3 3 6 6 9 9 1212 1515 1818 2121 00 Auto
AutoMode
Modeexit
exitdue
due to
to an
an alarm.
alarm.
overnightovernight
breakfast
breakfastlunch lunch dinner dinner overnight
overnightbreakfast
breakfast lunchlunch dinner
dinner overnight
overnight breakfast
breakfast lunch
lunch dinner
dinner

needed. There should be a greater distribution of insulin for Bolus to allow for correction and mealtime insulin

Basal (U/hr)

Basal (U/hr)
44- -Unidentified
Unidentified

versus Auto basal/Basal amount. The set and reservoir change should be performed every 2-3 days to maintain Pump
Pumpdid
the
didnot
notenter
enter Auto
Auto Mode
Mode or the origin
origin of
of
theexit
exitcannot
cannotbebeidentified.
identified.

a healthy infusion site and limit the probability of encountering site issues that can affect insulin absorption.
66- -BG
BGrequired
requiredfor
for Auto
Auto Mode
Mode

Meals and Carbs entered per day are shown to display any changes in a patient’s eating pattern.
4 3
BGwas
BG wasrequired
requiredto
to continue
continue in Auto Mode.
Mode.
Blood Glucose
Blood Glucose Manual Manual Suspend
Suspend Suspend
Suspend BolusBolus Target Exercise
Exercise
Auto-Basal
Auto-Basal Basal Basal Injection Target
SuspendSuspend on Lowon Low beforebefore
Low Low + Active
+ Active Insulin Injection
Insulin + temp target Time
Time change
change
CalibrationCalibration + temp target Other
Other

Assess for the appropriateness of the Active Insulin setting. It may need to be lessened to allow more frequent
correction insulin.

APPLICATION OF METHODOLOGY
With the Weekly Review report, identify Auto Mode exit reasons, post-prandial and
post-correction trends, based on findings determine need for adjustment to carb
ratio and/or active insulin time.
 10.0 9.1 9.5 8.4
8.9 9.1 8.4 8.6 8.4 8.5
8.2 8.0
7.1 7.4

CARELINK™ SYSTEM INSIGHTS FOR SMARTGUARD™ CARELINK™ SYSTEM INSIGHTS FOR SMARTGUARD™
4.8
3.9
3.9 2.8

22
AUTO MODE
0 3 – WEEKLY
6 9 12 REVIEW
15 18 21 REPORT
0 3 6 9 12 15 18 21
2.2
0 3 6 9 12 15 18 21 0 AUTO
3 6 MODE
9 12 15 – 18
WEEKLY
21 0 REVIEW REPORT 23
Nacht Frühstück Mittagessen Abendessen Nacht Frühstück Mittagessen Abendessen Nacht Frühstück Mittagessen Abendessen Nacht Frühstück Mittagessen Abendessen

Weekly Review (1 of 2)
7-2-2016 - 7-8-2016 (7 Days)

1 GLUCOSE AND INSULIN SECTION 3 EXIT REASONS

Weekly Review (1 of 2) Weekly Review (1 of 2)
7-2-2016 - 7-8-2016
Weekly Review (7
(1 Days)
of 2) 7-2-2016 - 7-8-2016
Weekly Review (7
(1 Days)
of 2)

1 1
7-2-2016 - 7-8-2016 (7 Days) 7-2-2016 - 7-8-2016 (7 Days)

Weekly Review (1 of 2) 22.2 22.2 22.2

22.2 22.2

7-2-2016 - 7-8-2016 (7 Days)

16.7 16.7
14.8 14.8
16.7 16.7

Use this report to evaluate sensor This list can be used to

14.8 14.8
11.4 11.4 11.4 11.4
11.1 10.8 10.5 11.1 10.8 10.5
9.8 10.2 9.8 10.2
10.0 11.4 11.4 9.1 9.5 8.4 10.0 11.4 11.4 9.1 9.5 8.4
8.9 9.1 8.4 8.9 9.1 8.4

Exit Reason Details

8.6 8.4 10.8 8.5 8.0 10.5 8.6 8.4 10.8 8.5 8.0 10.5
11.1 8.2 10.2 11.1 8.2 10.2
9.8 7.1 7.4 9.5 8.4 9.8 7.1 7.4 9.5 8.4
10.0 8.9 9.1 8.4 9.1 10.0 8.9 9.1 8.4 9.1
8.6 8.4 8.5 8.0 8.6 8.4 8.5 8.0
8.2 7.4 8.2 7.4
7.1 4.8 7.1 4.8
3.9 3.9
3.9 2.8 4.8 3.9 2.8 4.8
2.2 3.9 2.2 3.9

16.7
3.9 3.9
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 2.8 15 18 21 0 3 6 9 12 15 18 21 0 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 2.8 15 18 21 0 3 6 9 12 15 18 21 0

variability and daily patterns. The green determine exit reasons

2.2 2.2
0
overnight 3breakfast
6 9lunch 12 15
dinner 18 21 overnight
0 3 6
breakfast 9 lunch
12 15 dinner
18 21 overnight
0 3 breakfast
6 9 12
lunch 15 dinner
18 21 0overnight
3 6 9
breakfast 12
lunch 15 18
dinner 21 0 0
overnight 3breakfast
6 9lunch 12 15
dinner 18 21 overnight
0 3 6
breakfast 9 lunch
12 15 dinner
18 21 overnight
0 3 breakfast
6 9 12
lunch 15 dinner
18 21 0overnight
3 6 9
breakfast 12
lunch 15 18
dinner 21 0

14.8
breakfast lunch dinner breakfast lunch dinner

Basal (U/hr)

Basal (U/hr)
overnight breakfast lunch dinner overnight overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner overnight overnight breakfast lunch dinner overnight breakfast lunch dinner

1,5 - No Calibration

Basal (U/hr)

Basal (U/hr)
22.2

shaded area represents the range of and the specific details. 11.4 10.8
22.2 2
Exit Reason Details
Exit Reason Details
1,5 - No Calibration

11.4 2
Exit Reason Details
Exit Reason Details
1,5 - No Calibration

Sensor was not calibrated (e.g. Calibration not

22.2 1,5 - No Calibration 22.2 1,5 - No Calibration
22.2 Sensor was not calibrated (e.g. Calibration not 22.2 Sensor was not calibrated (e.g. Calibration not

11.1
Sensor was
accepted, BGnotnotcalibrated
received,(e.g. Calibration not
No Calibration Sensor was
accepted, BGnotnotcalibrated
received,(e.g. Calibration not
No Calibration
accepted,etc.).
occurred, BG not received, No Calibration
occurred, etc.).

9.8
accepted,etc.).
occurred, BG not received, No Calibration
occurred, etc.).
10.2
9.5
16.7 16.7

3.9 - 10.0 mmol/L (70-180 mg/dL) with If the same reason is listed
accepted, BG not received, No Calibration
16.7 16.7

10.0 9.1
2 - No SG values 2 - No SG values

8.9 9.1 8.4

13.4 13.2 13.3 13.4 13.2 13.3
13.4 13.2 13.3 12.2 2 - No SG values 13.4 13.2 13.3 12.2 2 - No SG values

8.6 8.4 8.5

12.2 12.2

16.7
10.8 11.0 10.8 SG values were not available (e.g. Lost sensor 10.8 11.0 10.8 SG values were not available (e.g. Lost sensor
11.1 10.1 10.8 11.0 10.8 SG values weresensor,
not available 11.1 10.1 10.8 11.0 10.8
Check(e.g. Lost sensor SG values weresensor,
not available
Check(e.g. Lost sensor

8.0
10.0 11.1 8.4 10.1 9.2 signal, Change connection, 10.0 11.1 8.4 10.1 9.2 signal, Change connection,
8.4 9.2 signal, Change sensor, Checksignal
connection, 8.4 9.2 signal, Change sensor, Checksignal
connection,

8.2
10.0 Transmitter depleted, Sensor not found, 10.0 Transmitter depleted, Sensor not found,

14.8
7.8 7.8

occurred, etc.). 7.1

7.8 7.2 Transmitter depleted, Sensor signal not found, 7.8 7.2 Transmitter depleted, Sensor signal not found,

7.4
6.4 7.2 etc.). 6.4 7.2 etc.).
5.6 6.4 6.0 etc.). 5.6 6.4 6.0 etc.).
4.9 5.6 6.0 4.9 5.6 6.0
4.9 4.9
3.9 3 - Alarms 3.9 3 - Alarms
3.9 3 - Alarms 3.9 3 - Alarms

an Auto Mode target of 6.7 mmol/L more than once, it will

2.2 2.2
0 2.23
0 6
3 9
6 12
9 15
12 18
15 21
18 210 03 36 69 9 12 1215 1518 18 21 21 0 0 3 3 6 6 9 9 1212 1515 1818 2121 00 Auto
AutoMode
Modeexit
exitdue
due to
to an
an alarm.
alarm.
0 2.23
0 6
3 9
6 12
9 15
12 18
15 21
18 210 03 36 69 9 12 1215 1518 18 21 21 0 0 3 3 6 6 9 9 1212 1515 1818 2121 00 Auto
AutoMode
Modeexit
exitdue
due to
to an
an alarm.
alarm.
overnightovernight
breakfast
breakfastlunch lunch dinner dinner overnight
overnightbreakfast
breakfast lunchlunch dinner overnight
overnight breakfast lunch dinner overnightovernight
breakfast
breakfastlunch lunch dinner dinner overnight
overnightbreakfast
breakfast lunchlunch dinner overnight
overnight breakfast lunch dinner

16.7
dinner breakfast lunch dinner dinner breakfast lunch dinner

11.4 11.4

Basal (U/hr)

Basal (U/hr)
4.8

Basal (U/hr)

Basal (U/hr)
10.8
44- -Unidentified
Unidentified 44- -Unidentified
Unidentified

11.1 10.2 10.5

3.9
Pump
Pumpdid didnot
notenter
enter Auto
Auto Mode
Mode or the origin
origin of
of Pump
Pumpdid didnot
notenter
enter Auto
Auto Mode
Mode or the origin
origin of
of

9.8 9.5
the
theexit
exitcannot
cannotbe
8.4
beidentified.
identified. the
theexit
exitcannot
cannotbebeidentified.
identified.

10.0 9.1
2 - 3.9
8.9 9.1 8.4

(120 mg/dL) indicated by a solid green be grouped together in

8.6 8.4 8.5
No SG values 2.8
13.4 8.0
13.3
66- -BG
BGrequired
requiredfor
for Auto
Auto Mode
Mode 66- -BG
BGrequired
requiredfor
for Auto
Auto Mode
Mode

8.2
7.1 Weekly Review (1 of 2) 13.2 4 Blood Glucose
Blood Glucose
CalibrationCalibration
7.4 Auto-Basal
Auto-Basal Basal Basal Manual Manual
SuspendSuspend
Suspend
Suspend
on Lowon Low
Suspend
Suspend
beforebefore
Low Low
BolusBolus
+ Active
+ Active Insulin
Injection
Insulin Injection
Target
Target
+ temp
+ temp target
target
Exercise
Exercise
Other
Other
Time
Time change
change
BGwas
BG wasrequired
requiredto
to continue
continue in Auto Mode.
Mode.
3
2.2
4 Blood Glucose
Blood Glucose
CalibrationCalibration
Auto-Basal
Auto-Basal Basal Basal Manual Manual
SuspendSuspend
Suspend
Suspend
on Lowon Low
Suspend
Suspend
beforebefore
Low Low
BolusBolus
+ Active
+ Active Insulin
Injection
Insulin Injection
Target
Target
+ temp
+ temp target
target
Exercise
Exercise
Other
Time
Time change
change
BGwas
BG wasrequired
requiredto
to continue
continue in Auto Mode.
Mode.
3
12.2
Other

0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12
line. The low and 10.1high limit of this green this table.
7-2-2016 - 7-8-2016 (7 Days) 11.0
4.8
10.8 3.9 10.8 SG values were not availablelunch
(e.g. Lost sensor
3.9
11.1 2.8
overnight breakfast dinner overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunc
2.2
910.012
8.4 0 9.2 signal, Change sensor, Check connection,
shaded area can be adjusted in the CareLink™ system settings, however,
0 3 6 15 18 21 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0

Basal (U/hr)
breakfast 7.8
lunch dinner
Transmitter depleted, Sensor signal not found,
overnight breakfast lunch dinner overnight overnight breakfast lunch dinner overnight breakfast lunch dinner
7.2
etc.).
the target4.9 of 6.7 mmol/L (120 mg/dL) 5.6 is the setting in the pump and
6.4
Basal (U/hr)

22.2
6.0

16.7 3.9 cannot be changed unless a temporary target of 8.3 mmol/L (150 mg/dL)
14.8
3 - Alarms
2.2
0 3 6 9 is programmed
12 15 18 in the
21 pump 0 (see
3 page
6 12).
9 12 11.4
15 18 21 0 3 11.4
6 9 12 15 18 21 0 Auto Mode exit due to an alarm.
11.1 10.8 10.5
9.8 10.2
9.5
Exit Reaso
8.4
10.0
Nacht
8.2
8.9
Frühstück
9.1 8.4
Mittagessen
8.6 8.4 Abendessen 8.5
9.1
Nacht 8.0 Frühstück Mittagessen Exit Reason DetailsNacht
Abendessen Frühstück Mittagessen Abendessen
7.1 7.4
1,5 - No Calibration
1,5 - No Calibration
22.2 4.8
3.9 Sensor was not calibrated (e.g. Calibration not 22.2
3.9 2.8
2.2
accepted, BG not received, No Calibration 4 - Unidentified Sensor was not calibrate
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 occurred,
6 etc.).
9 12 15 18 21 0 accepted, BG not receive
16.7
overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner occurred, etc.).
13.4 13.2 13.3 2 - No SG values Pump
16.7
did not enter Auto Mode or the origin of
Basal (U/hr)

10.8 11.0 10.8

12.2
SG values were not available (e.g. Lost sensor
the exit cannot be identified.
11.1
8.4
10.1 13.4 13.2 13.3 2 - No SG values
10.0 9.2 signal, Change sensor, Check connection,
7.8 Transmitter depleted, Sensor signal not found, 12.2
7.2 11.0
6.4 etc.). 10.8 10.8 SG values were not avai
5.6 6.0 11.1 10.1
4.9 8.4 9.2 signal, Change sensor, C
3.9 3 - Alarms 6 -10.0
BG required for Auto Mode Transmitter depleted, Se
7.8
7.2
2.2
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 6.4 etc.).
Exit
Auto Mode exitReason Details
due to an alarm. 5.6 6.0
overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner
BG was required to continue in Auto 4.9
Mode.
1,5 - No Calibration

Auto Basal is displayed in pink on the bottom

Basal of the graph. Bolus amounts are presented in purple and carbs
Blood Glucose Manual Suspend Suspend Bolus Target Exercise 3 - Alarms
Auto-Basal
22.2 Injection 3.9
Time change
Basal (U/hr)

Calibration Suspend on Low before Low Sensor +wasActive Insulin (e.g. Calibration
not calibrated not + temp target Other
4 - Unidentified 2.2

entered are labeled in orange. You will notice an active insulin curve for every bolus delivered
Pump did shown byorthe
accepted, BG not received, No Calibration
occurred, etc.).
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 Auto Mode exit due to an
16.7 not enter Auto Mode the origin of
overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner
lighter shade of purple. When patients exit from Auto Mode, preset basal rates are shown as solid pink lines.
the exit cannot be identified.
2 - No SG values 13.4 13.2 13.3

Basal (U/hr)
12.2
10.8 11.0 10.8 SG values were not available (e.g. Lost sensor
11.1
8.4
10.1
9.2
6 - BG required for Auto Mode
signal, Change sensor, Check connection,
4 - Unidentified
10.0
7.8 Transmitter depleted, Sensor signal not found,
7.2 BG was required to continue in Auto Mode.
etc.).

2 AUTO MODE EXITS (AND SUSPENDS)

Blood Glucose Manual Suspend 5.6 Suspend
6.4 Bolus Target 6.0 Exercise Pump did not enter Auto
Auto-Basal Basal4.9 Injection
Calibration Suspend on Low before Low + Active Insulin + temp target Other
Time change
the exit cannot be identif
3.9 3 - Alarms
2.2
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0

4 LEGEND
Auto Mode exit due to an alarm.
overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner 6 - BG required for Auto
Weekly Review (1 of 2)
Basal (U/hr)

7-2-2016 - 7-8-2016 (7 Days) 4 - Unidentified BG was required to conti

Blood Glucose Manual Suspend Suspend Bolus Target Exercise
Auto-Basal Basal Injection Time change
Pump did not enter Auto Mode or the origin of Calibration Suspend on Low before Low + Active Insulin + temp target Other
the exit cannot be identified.

22.2
6 - BG required for Auto Mode

BG was required to continue in Auto Mode.

Blood Glucose Manual Suspend Suspend Bolus Target Exercise
16.7 Auto-Basal Basal Injection Time change
Calibration Suspend
14.8 on Low before Low + Active Insulin + temp target Other

11.4 11.4
11.1 10.8 10.5
9.8 10.2
10.0 9.1 9.5 8.4
8.9 9.1 8.4 8.6 8.4 8.5
8.2 8.0
7.1 7.4

4.8
3.9
3.9 2.8
2.2
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0
overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner
Basal (U/hr)

When a patient is in Manual Mode, it will be shown in a shaded window with an exit event number assigned.
Assess for the duration of each exit and the associated exit reason.
While in Manual Mode, the suspend function of the pump can be turned on. In the event of a Exit lowReasonsensor glucose
Details
suspend, the duration of these suspends are illustrated by the orange bars on the graph (example not pictured),
22.2
1,5 - No Calibration

similar to what is displayed on the patient’s CGM screen from the pump. A Suspend on low event will feature
Sensor was not calibrated (e.g. Calibration not
accepted, BG not received, No Calibration
occurred, etc.).

pink squares on the basal line, while a Suspend before low event will feature pink triangles on the basal line.
16.7

2 - No SG values 13.4 13.2 13.3

12.2
10.8 11.0 10.8 SG values were not available (e.g. Lost sensor
11.1 10.1
10.0 8.4 9.2 signal, Change sensor, Check connection,
7.8 Transmitter depleted, Sensor signal not found,
7.2
6.4 etc.).
5.6 6.0
4.9
3.9 3 - Alarms
2.2
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 Auto Mode exit due to an alarm.
overnight breakfast lunch dinner overnight breakfast lunch dinner overnight breakfast lunch dinner
Basal (U/hr)

4 - Unidentified

Pump did not enter Auto Mode or the origin of

the exit cannot be identified.

6 - BG required for Auto Mode

BG was required to continue in Auto Mode.

Blood Glucose Manual Suspend Suspend Bolus Target Exercise
Auto-Basal Basal Injection Time change
Calibration Suspend on Low before Low + Active Insulin + temp target Other
 CARELINK™ SYSTEM INSIGHTS FOR SMARTGUARD™ EXAMPLE OF ADHERENCE REPORT
24 AUTO MODE – MEAL BOLUS WIZARD REPORT 25

REVIEWING SMARTGUARD™ AUTO MODE REPORTS FOR MINIMED™ 670G SYSTEM – Use this report to evaluate pump and sensor use.
MEAL BOLUS WIZARD
Adherence (1 of 1)
The Meal Bolus Wizard report shows the effect of the boluses that the patient has taken for their meals 7-2-2016 - 7-15-2016

as Breakfast, Lunch, Dinner, and also boluses taken over the Overnight time period.
1 2
Adherence (1 of 1)
7-2-2016 - 7-15-2016
Glucose Measurements Bolus Events Fill Events
Meal Bolus Wizard
Sensor Bolus Suspend
7-2-2016 - 7-15-2016 (14 Days) BG Duration Manual Wizard With With Cannula Cannula Tubing Tubing Duration
Readings
Glucose (h:mm)
Measurements Boluses
Bolus Events Events Food Correction Overridden Fill Rewind
Events Fills Amount (U) Fills Amount (U) (h:mm)
All Meal Boluses Meal Boluses Analyzed: Boluses with noteworthy pattern or outcome are used for analysis
Saturday
12 23:35
Sensor 3 16
Bolus 11 3 1 1 1 0.3 1 9.1697 0:07
Suspend
7/2/2016
Breakfast - All Boluses Stats Breakfast - Analyzed Meals Observations BG Duration Manual Wizard With With Cannula Cannula Tubing Tubing Duration
Avg. SG Sunday Readings (h:mm) Boluses Events Food Correction Overridden Rewind Fills Amount (U) Fills Amount (U) (h:mm)
(mmol/L) 10.6 10.2
Time 6:00 - 10:00 12 23:55 8 3 4 0:03
22.2
7/3/2016
Saturday
12 23:35 3 16 11 3 1 1 1 0.3 1 9.1697 0:07
Bolus Count 30 7/2/2016
Glucose (mmol/L)

Monday
16.7 8 24:00 8 7 1
7/4/2016
Carb Ratio (g/U) 12.0 Sunday
12 23:55 8 3 4 0:03
11.1 7/3/2016
10.0 Tuesday
Avg. Carbs (g) 31 ± 24
6 24:00 7 5 1
7/5/2016
Monday
3.9 8 24:00 8 7 1
2.2 7/4/2016
Avg. Bolus (U) 3.0 ± 2.4 Wednesday
10 22:30 8 7 4 1 1 0.3 1 7.6107 0:37
7/6/2016
Tuesday
6 24:00 7 5 1
Lunch - All Boluses Stats Lunch - Analyzed Meals Observations 7/5/2016
Thursday
Avg. SG 5 23:30 5 4 1
Time 11:00 - 15:00 7/7/2016
(mmol/L) 7.8 7.3 Wednesday
22.2 10 22:30 8 7 4 1 1 0.3 1 7.6107 0:37
7/6/2016
Bolus Count 30
Friday
9 21:25 13 10 2
Glucose (mmol/L)

16.7 7/8/2016
Thursday
5 23:30 5 4 1
Carb Ratio (g/U) 17.0 7/7/2016
11.1 Saturday
10.0 8 24:00 10 10 1 1 0.3 1 9.9169 0:14
7/9/2016
Avg. Carbs (g) 25 ± 17 Friday
9 21:25 13 10 2
7/8/2016
3.9 Sunday
2.2
Avg. Bolus (U) 1.7 ± 1.2
4 24:00 8 7 1
7/10/2016
Saturday
8 24:00 10 10 1 1 0.3 1 9.9169 0:14
7/9/2016
Monday
Dinner - All Boluses Stats Dinner - Analyzed Meals Observations 12 17:00 8 5 4 1
7/11/2016
Avg. SG Sunday
Time 16:00 - 22:00 4 24:00 8 7 1
(mmol/L) 10.1 8.2 7/10/2016
22.2 Tuesday
9 23:55 8 8 0:35
Bolus Count 29 7/12/2016
Monday
Glucose (mmol/L)

16.7 12 17:00 8 5 4 1
7/11/2016
Wednesday
Carb Ratio (g/U) 15.0 10 23:55 11 9 4 2 1 0.3 1 9.4095 0:11
11.1 7/13/2016
10.0 Tuesday
9 23:55 8 8 0:35
Avg. Carbs (g) 20 ± 13 7/12/2016
Thursday
3.9 4 24:00 10 8 1
7/14/2016
2.2 Avg. Bolus (U) 1.2 ± 0.8 Wednesday
10 23:55 11 9 4 2 1 0.3 1 9.4095 0:11
7/13/2016
Friday
5 24:00 10 8 2
Night - All Boluses Stats Night - Analyzed Meals Observations 7/15/2016
Thursday
4 24:00 10 8 1
Avg. SG 7/14/2016
(mmol/L) 11.0 9.0
Time 22:00 - 6:00 Summary 7.8/day 13d 11hrs 0.0/day 8.8/day 78.5% 21.5% 1.5% 5 4 0.3U 4 9.0U/fill 1hrs 47m
22.2 45m /fill
Friday
Bolus Count 2 5 24:00 10 8 2
7/15/2016
Glucose (mmol/L)

16.7

Carb Ratio (g/U) 20.0, 20.0

11.1 Summary 7.8/day 13d 11hrs 0.0/day 8.8/day 78.5% 21.5% 1.5% 5 4 0.3U 4 9.0U/fill 1hrs 47m
10.0 45m /fill
Avg. Carbs (g) 7±2
Partial day Suspend Suspend On Low Suspend Before Low Note: Partial days will not be included in summary averages. Days on which a time change occurred are considered to be partial days.

3 4
3.9
2.2 Avg. Bolus (U) 0.3 ± 0.1

Partial day Suspend Suspend On Low Suspend Before Low Note: Partial days will not be included in summary averages. Days on which a time change occurred are considered to be partial days.

A default setting for meal times can be fixed for As usual, there is an expected rise from the post-
an individual patient or for the entire clinic. These prandial absorption of the meal glucose followed by
settings can be accessed in the system preferences. the expectation for glucose to return to baseline. It
The number of boluses, the carb ratio for that is important to note that the post-meal range shifts
1 SENSOR DURATION 3 MANUAL SUSPEND
time period, the average amount of carbs and the upward to a post prandial target of 5.5 - 10.0 mmol/L
average bolus size in units of insulin are displayed in (100-180 mg/dL). In this example, for all three meals Assess the amount of time per day the sensor Evaluate manual suspend events indicated by the
the table next to the sensor graph. the red areas appear to suggest hypoglycaemia and is worn. Encourage and promote full 24 hour green icon and included in the summation of total
The Bolus line indicates when a bolus was given using the post-prandial glucose for breakfast and lunch wear. Note that every 7th day a sensor change is suspend duration. This icon is displayed in the
the Bolus Wizard™ feature in Manual Mode or when falls below 3.9 mmol/L (70 mg/dL). recommended so full 24 hour wear for that day will Suspend Duration column of the report.
a bolus for a meal was given while in Auto Mode. You You can use this report to discuss carbohydrate not be expected.
can evaluate the one-hour time period preceding counting, timing of the meal, assessing your 4 SUSPEND EVENTS
the bolus and then the multiple hours after the bolus. ability to re-evaluate and reset the carbohydrate 2 SUSPEND DURATION Evaluate the occurrence of SmartGuard™ events
Assess whether or not the glucose value has started ratios by different time buckets, and assure that
Evaluate the total amount of time the pump is per day. Each colored icon indicates a designated
rising at the time of the bolus. This may indicate that the meals are being handled appropriately. The
suspended per day (includes manual suspend, suspend event. Refer to the Weekly Review
the patient is not bolusing before they start their right side of the report can be used to note any
Suspend before low, and Suspend on low events). report for the frequency and duration of each
meals, in which counseling may be necessary. observations pertaining to each meal period.
suspend event. These icons would be displayed
in the Suspend Duration column of the report. No
APPLICATION OF METHODOLOGY suspend events occurred in this example.
Assess post-prandial control using the Meal Bolus Wizard report.
 EXAMPLE OF DEVICE SETTINGS REPORT EXAMPLE OF DEVICE SETTINGS REPORT
26 27

Device Settings
Use this report to evaluate pump and sensor settings. 7/10/2016
Device Settings
Device Settings

3SmartGuard 5Basal (Continued) 6Reminders

7-10-2016
7/10/2016

SmartGuard Basal
Basal 4 (Continued)Basal 5 Workday Day Off Sick Day Reminders
Low Reservoir Warning Insulin Units
Auto Mode
SmartGuard Basal (Continued) Reminders
Auto Mode Auto Mode On Basal 4
24-Hour Basal 5
24-Hour Workday
24-Hour 24-Hour
Day Off 24-Hour
Sick Day Amount
Low Reservoir Warning 20 U Units
Insulin
Auto Mode Basal 4
Total
-- Basal 5
Total
-- Workday
Total
--
Day Off
Total
--
Sick Total
Day -- Low Reservoir Warning Insulin Units
Auto Mode BGMode
Alert Off
On 24-Hour 24-Hour 24-Hour 24-Hour 24-Hour Bolus BG Check
Amount OffU
20
Auto -- -- -- -- -- Amount 20 U
Auto Mode On 24-Hour
Total 24-Hour
Total 24-Hour
Total 24-Hour
Total 24-Hour
Total
Off Time --
U/Hr Time --
U/Hr Time --
U/Hr Time --
U/Hr Time --
U/Hr BolusSet
BGChange
Check Off
Off
Auto Mode BG Alert Total Total Total Total Total
Device Settings High Alerts
Auto Mode BG Alert OffOn (Snooze 1:00) Bolus BG Check Off
Time-- U/Hr-- Time-- U/Hr-- Time-- U/Hr-- Time-- U/Hr-- Time-- U/Hr-- Missed MealSetBolus
Change Off
7-10-2016 High Alerts
Start
Alert Alert
On (Snooze
Rise1:00)
Alert Time U/Hr Time U/Hr Time U/Hr Time U/Hr Time U/Hr Set Change Off
High Alerts
Time
High (mg/dL) On Before
On (Snooze 1:00)
Limit (mg/dL)
-- -- -- -- -- -- -- -- -- -- Missed Meal
NameBolus Start End
Start Alert
High Alert
High -- -- -- -- -- -- -- -- -- -- Missed Meal Bolus
Alert Alert Rise Alert Meal 1 Off Off
Time
Start High (mmol/L)
0:00 16.7 Onx Before Rise Alert Name Start End
High (mg/dL) On Before Limit(mmol/L) Name Start End
Time High High Limit (mg/dL)
Basal Bolus 8:00 15.3 x
High High Meal12
Meal Off
Off Off
Off
0:00
15:30 16.7
15.3 xx Meal 1 Off Off
0:00
8:00 16.7
15.3 xx Meal23 Off Off
Updates Bolus Wizard On Meal Off Off
Maximum Basal Rate 1.00 U/Hr Easy Bolus Off 8:00 15.3
15:30 15.3 xx Meal 2 Off Off
Units g, mmol/L 15:30 15.3 x Meal34
Meal Off
Off Off
Off
Bolus Increment 0.1 U Meal 3 Off Off
Basal 1 (active) Basal 2 Basal 3 Active Insulin Time Meal45
Meal Off
Off Off
Off
3:00 Bolus Speed Standard Meal 4 Off Off
24-Hour (h:mm) Meal56 Off Off
24-Hour 24-Hour Meal Off Off
8.975 U -- -- Meal 5 Off Off
Total Total Total Maximum Bolus 7.0 U Dual/Square On/Off Meal67
Meal Off
Off Off
Off
Low Alerts On (Snooze 0:20)
Meal 6 Off Off
Time U/Hr Time U/Hr Time U/Hr Carbohydrate Ratio Insulin Sensitivity Blood Glucose Meal78 Off Off
Alert Resume Meal Off Off
Low Alerts
Start Low AlertOn (Snooze 0:20) Meal 7 Off Off
00:00 0.400 -- -- -- -- (g/U) (mmol/L per U) Target (mmol/L) Low Alerts
Time (mg/dL)
Suspend On Before
(Snooze 0:20)
On Low Alert Resume
Basal
Personal Reminders
Meal 8 Off Off
Start Low Alert Low Alert Meal 8 Off Off
01:00 0.375 Suspend Alert Resume
Before Basal
Time Ratio Time Sensitivity Time Low High Start (mmol/L)
0:00
Time Low
3.6 Off Alert
x Name
Personal Reminders Time
Suspend On Low Before Basal
04:00 0.350 Time (mg/dL) On Low Low Alert Personal Reminders
0:00 20.0 0:00 13.9 0:00 6.1 6.1 Low Alert NameReminder 1 Off Time
0:00 3.6 Off x
05:00 0.375 0:00 3.6 Off x Name Time
6:00 10.0 5:00 11.1 5:00 5.5 5.5 Reminder12
Reminder Off
Off
06:00 0.450 Reminder 1 Off
10:00 15.0 9:30 10.5 9:00 6.6 6.6 Reminder23
Reminder Off
Off
08:30 0.300 Reminder 2 Off
15:30 17.0 17:00 10.0 22:00 6.1 6.1 Reminder34 Off
Reminder Off
09:00 0.300 Reminder 3 Off
22:00 20.0 21:00 11.1 Reminder45 Off
Reminder Off
13:00 0.300 Reminder 4 Off
Sensor Reminder56
Reminder Off
Off
15:00 0.375 Reminder 5 Off
Sensor Sensor On BG Check
Reminder 6 Off
Off
16:00 0.425 Sensor Reminder 6 Off
Sensor On Medication
BG Check Off
Off
18:00 0.400 Calibration Reminder
Sensor On BG Check Off
20:00 0.400 Preset Bolus Medication Off
Calibration Reminder
Calibration Time
Reminder 1:00
On Utilities Medication Off
23:00 0.425 Calibration Reminder On
Name Normal Square Updates Calibration Reminder Time 1:00 Utilities Block Mode Off
Notes
Calibration Reminder Time 1:00 Utilities
Bolus 1 Time
BlockFormat
Mode 24 Hr
Off
Block Mode Off
Breakfast Notes TimeBrightness
Format 24Auto
Hr
Notes Time Format 24 Hr
Dinner Backlight Timeout 60s
Brightness Auto
Lunch Brightness Auto
Remote
Backlight Bolus
Timeout On
60s
Snack Backlight Timeout 60s
Audio
Remote Options
Bolus Vibrate
On
Bolus 2 Remote Bolus On
AlarmOptions
Audio Volume --
Vibrate
Bolus 3 Audio Options Vibrate
Auto Suspend --Off

4 7
Alarm Volume
Bolus 4 Alarm Volume --
Auto Suspend Off
Auto Suspend Off
Preset Temp

Name Rate Duration Name Rate Duration

High Activity Temp 1

Moderate Temp 2
Activity

3 SENSOR SETTINGS
Low Activity Temp 3

1 Sick Temp 4
2 6 REMINDERS
Evaluate parameters of the sensor settings. Are These settings are turned on to assist with
alerts set appropriately and to the needs of the BG checks, and missed meal boluses. It is best
1 BASAL SETTINGS 2 BOLUS SETTINGS patient for proper glucose control? Assess if practice to have the patient use reminders for
the timing of sensor alarms create a nuisance proper maintenance of reservoir and infusion set
Evaluate basal settings. Is the number of basal Evaluate bolus settings. Are they appropriate? to the patient which prevent them from wearing changes every 2-3 days. These features
rates appropriate or excessive? Is variance Are the Bolus Wizard™ glucose targets the sensor. are essentially useful in assisting a patient
between rates appropriate? appropriate? Is the Active Insulin time
with adherence while on pump technology.
appropriate? Overall, do the settings make
4 NOTES
sense?
7 UTILITIES
Use this section to make notes for patient records.
No more than 1 to 2 changes are recommended These are personalised settings set by the
at a time. Provide a copy of this page as instruction user according to their preference of time
APPLICATION OF METHODOLOGY of changes for the patient. Scan or save the entire format, brightness, backlight timeout, and
Make changes and document findings, setting adjustments, SmartGuard™ Auto CareLink™ system software report as a PDF to remote bolus.
Mode coaching and follow-up plan on the Device Settings report. attach to the Patient’s EMR.

5 ADDITIONAL BASAL SETTINGS

These are additional basal patterns for different

needs of insulin demand.
 ALERTS AND ALARMS IN SMARTGUARD™ AUTO MODE MODES OF OPERATION REFERENCE TABLE
28 29

The following are some common alerts. Alert on high and Alert on low alerts apply to both Manual Mode The following is a reference table with major delivery options available for Manual Mode and Auto Mode.
and Auto Mode. SmartGuard™ Suspend features do not apply to Auto Mode. Please see The MiniMed™ 670G System User Guide for complete information.

Please see The MiniMed™ 670G System User Guide for a complete list of alarms and alerts.
MANUAL MODE

ALARM OR ALERT CAUSE STEPS TO TAKE Mode CGM Options Home Screen Bolus Delivery Options Basal Delivery Suspend Options

Auto Mode exit The pump has exited Auto Mode Follow instructions for any alert Pump without CGM Bolus Wizard™ calculator, Uses the Manual Suspend
or alarm you received. Check the uses programmed carb programmed
Auto Mode Readiness status ratio, insulin sensitivity, basal delivery
screen for information to re-enter BG target, and active settings
Auto Mode. insulin time settings Temporary basal
Manual bolus rates available
High SG SG has been high for over one hour. This value High SG
is based on a set glucose threshold and length Check infusion set. Check Remote bolus Preset temporary
of time: 16.7 mmol/L (300 mg/dL) or higher ketones. Consider injection. basal rates
Square Wave and Dual
™

for one hour; 13.9 mmol/L (250 mg/dL) or Monitor BG. Wave™ bolus
Followed by:
higher for three hours.
Preset bolus
Auto mode exit
Auto Mode Exit
Monitor BG and treat as Easy bolus
This alert can not be silenced and is always
necessary. Enter BG to continue in
enabled whenever the pump is in Auto Mode. Pump with CGM Bolus Wizard™ calculator, Uses the Manual Suspend
Auto Mode.
uses programmed carb programmed
Auto Mode min delivery Alerts you when your pump has been Perform fingerstick and enter a ratio, insulin sensitivity, basal delivery
delivering insulin at your minimum Auto new BG. BG target, and active settings
Mode basal delivery rate for 2 1/2 hours. Your insulin time settings Temporary basal
personal minimum Auto Mode basal delivery Manual bolus rates available
rate is automatically determined.
Remote bolus Preset temporary
Auto Mode max delivery Alerts you when your pump has been Perform fingerstick and enter a basal rates
Square Wave and Dual
™

delivering insulin at your maximum Auto Mode new BG. Wave™ bolus
basal delivery rate for 4 hours. Your personal
Preset bolus
maximum Auto Mode basal delivery rate is
automatically determined. Easy bolus

BG required A new BG entry is required for Auto Mode Perform fingerstick and enter a Pump with CGM, Bolus Wizard™ calculator, Uses the Manual Suspend
new BG. Suspend before low uses programmed carb programmed Suspend before
or Suspend on low ratio, insulin sensitivity, basal delivery low
Bolus recommended Auto Mode recommends a correction bolus Consider delivering the enabled BG target, and active settings
based on a BG that you have entered. recommended correction bolus. insulin time settings Suspend on low
Temporary basal
Manual bolus rates available
High BG xxx mmol/L or A BG that you entered is above 13.9 mmol/L Check infusion set. Check
Remote bolus Preset temporary
mg/dL (250 mg/dL). ketones. Monitor BG.
basal rates
Square Wave™ and Dual
Note: The instructions for a High BG Alert in
Wave™ bolus
Auto Mode are different than the instructions
for a High BG alert in Manual Mode. Preset bolus
Easy bolus
Auto Mode off Due to an alarm, the Auto Mode setting in the Check Auto Mode Readiness
SmartGuard menu has turned off status screen for information to
re-enter Auto Mode.

Low SG xx mmol/L or mg/dL SG is at or below 2.8 mmol/L (50 mg/dL) Perform fingerstick and treat as
(2.8 mmol/L (50 mg/dL) needed. Monitor BG.
This alert cannot be silenced and is always
or below) enabled whether the pump is in Auto Mode or
Manual Mode.
 MODES OF OPERATION REFERENCE TABLE MINIMED™ 670G SYSTEM PUMP INITIATION SETTINGS
30 31

The following is a reference table with major delivery options available for Manual Mode and Auto Mode. Please ask your Medtronic representative for this Initiation Settings Form.
Please see The MiniMed™ 670G System User Guide for complete information.

Prescriber’s Instructions to Patient for Manual Mode – Pump Settings

SMARTGUARD™ AUTO MODE
Patient Name: Date:
Mode CGM Options Home Screen Bolus Delivery Options Basal Delivery Suspend Options
Weight: Current Regimen:
Auto Mode Auto Mode Bolus Automatic delivery Manual Suspend Pre-pump TDD
(Auto Basal delivery) impacted by Carb Ratio of basal insulin Transfer settings from current pump
and Active Insulin Time based on recent
Settings insulin delivery OR
needs and SG Use the following basal and bolus settings
Patient enters carb
values, to target of
grams and BGs
6.7 mmol/L (120
Pump may recommend
BASAL SETTINGS
mg/dL)
bolus when BG >8.3 Time Rate Max Basal
May set a (units/hour)
mmol/L (150 mg/dL) 00:00 - ________ _________units/hour

Basal Pattern
temporary target
entered ________ - ________ _________units/hour
of 8.3 mmol/L
Patient accepts or ________ - ________ _________units/hour
(150 mg/dL) for up _________________
cancels bolus ________ - ________ _________units/hour
to 12 hours
________ - ________ _________units/hour Default: 2.0 Units/hour

________ - ________ _________units/hour

Auto Mode Auto Mode Bolus Automatic delivery Manual Suspend BOLUS SETTINGS
(Safe Basal delivery) impacted by Carb Ratio of basal insulin at a Carb Ratio Grams/Unit Max Bolus
and Active Insulin Time fixed rate (units)

Meal Bolus
00:00 - ________ ________ grams/unit
Settings Does not use SG ________ - ________ ________ grams/unit
Patient enters carb values to adjust ________ - ________ ________ grams/unit _________________
grams and BGs basal rate ________ - ________ ________ grams/unit Default: 10 Units

Pump may recommend System has a data ISF Target Ranges mmol/L (mg/dL) Active Insulin
bolus when BG >8.3 gap; will resume Time (hours)

Correction
00:00 - _______ _____mmol/L/unit (mg/dL/unit) 00:00 - _______ _______ - _______

Bolus
mmol/L (150 mg/dL) Auto Basal delivery _______ - _______ _____mmol/L/unit (mg/dL/unit) _______ - _______ _______ - _______
entered when resolved or _______ - _______ _____mmol/L/unit (mg/dL/unit) _______ - _______ _______ - _______ ____________
will exit Auto Mode _______ - _______ _____mmol/L/unit (mg/dL/unit) _______ - _______ _______ - _______
2-8 hours in 15
Patient accepts or minute increments
if not resolved
cancels bolus
within 90 minutes. Bolus Wizard™ calculator not currently being used. Settings above have been calculated based on:
Current TDD of units Total Daily Bolus units.

Insulin instructions for transition to pump:

Comments:

These instructions are valid for 6 months unless otherwise specified here: months.

Prescriber Name: Signature: Date:

Call HCP for severe low BG or if ketones occur. Call Medtronic for technical assistance at 01923 205167.
 MINIMED™ 670G SYSTEM INITIATION SETTINGS REFERENCES AND SUGGESTED READING
32 33

Please ask your Medtronic representative for this Initiation Settings Form. REFERENCES
NEW USER 1. Bergenstal R, Garg S, Weinzimer, et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1
diabetes. JAMA. 2016;316(13):1407-1408.
Prescriber’s Instructions to Patient for Manual Mode and Auto Mode 2. Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin
Patient Name: Date: delivery system in adolescents and adults with type 1 diabetes. Diabetes Technol Ther. 2017:19(3):155-163.

SUGGESTED READING
The MiniMed™ 670G System User Guide
MANUAL MODE – CGM SETTINGS Contains complete technical information on product use, including all Warning and Precautions.
Low Settings High Settings
Pumping Protocol: A Guide to Insulin Pump Technology Initiation
Time Segments Low Limit SmartGuard™ Settings Time Segments High Limit High Alert Settings
2.8 - 5.0 mmol/L Alert before low and Resume basal alert are Alert before High and Rise alert are
Contains information on the initiation and fine-tuning of insulin pump technology.
(50 - 90 mg/dL) available but not routinely recommended. available but not routinely recommended.

00:00 - ________ ____ mmol/L or mg/dL …… Suspend before low* 00:00 - ________ ____ mmol/L or mg/dL …… Alert on high
A Guide to Personal Continuous Glucose Monitoring for the MiniMed™ 640G System
_______ - ________ ____ mmol/L or mg/dL …… Suspend before low* _______ - ________ ____ mmol/L or mg/dL …… Alert on high Contains information on the initiation and fine-tuning of sensor-augmented pump technology (SAP).
_______ - ________ ____ mmol/L or mg/dL …… Suspend before low* _______ - ________ ____ mmol/L or mg/dL …… Alert on high For a listing of indications, contraindications, precautions, warnings, and potential adverse events,
_______ - ________ ____ mmol/L or mg/dL … Suspend before low* _______ - ________ ____ mmol/L or mg/dL … Alert on high
please refer to the IFU.
…… Alert before High set
* Suspend before low will not automatically turn back on if pump exits
Auto Mode. The patient must enable this setting when in Manual Mode. … Rise alert set
Low Snooze: min (5 min to 1 hr; Default = 20 min) High Snooze: min (5 min to 3 hrs; Default = 1 hour)

SMARTGUARD™ AUTO MODE SETTINGS (Adjustments made here will replace the Manual Mode settings above)
Initiate Auto Mode on ___________ (date) Carb Ratio Active Insulin Time
Requires a minimum of 48 hours (from midnight) of pump
use prior to activation. Use existing settings Use ______________ hrs
Recommendation: ≥ 7days should be left between Recommendation: 3-4 hours. Manual Mode Active Insulin time
Manual Mode and Auto Mode >4 hours should be decreased to 4 hours at Auto Mode initiation.

Auto Mode BG Alert: O

 n (recommended)
Carb Ratio Grams/Unit Alert on Low: On
Off Recommend On at 3.8 mmol/L (or 70 mg/dL) at initiation.
Alert must be On to receive an audio alert when a BG is 00:00 - __________ ________ grams/unit
required for Auto Mode. If set to Off, only a visual banner
will display on screen. __________ - __________ ________ grams/unit
__________ - __________ ________ grams/unit

__________ - __________ ________ grams/unit

These settings are valid for 6 months unless otherwise specified here: (Date)
Comments:

Prescriber Name: Signature: Date:

 NOTES NOTES
34 35
 NOTES
36
37
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