A Patient Safety Initiative

For Insulin Pumps

Manufacturing Standards to improve insulin pump
use and medical outcomes
These proposals are near final, although suggestions for editorial
changes are still welcome.
Send your approval or comments to: John Walsh, PA, CDE at
jwalsh@diabetesnet.com or by calling (619) 497-0900
Introduction
Over 500,000 insulin pumps are in use around the world, yet no formal
guidelines regarding manufacturing standards and medical
practice have been adopted by the diabetes clinical community
and pump manufacturing industry.
These are suggestions for such standards and once approved will be
incorporated into future insulin pumps or into current pumps where
software changes allow.
These manufacturing standards are designed to
 Provide safer dosing increments to pump users
 Allow clinicians to make consistent dosing decisions when managing
a variety of pumps
 Allow adjunctive medical and accessory personnel (ER, surgical,
school nurses, etc.) to more easily be trained and interact with insulin
pumps
Background
 Older insulin pumps were primarily designed to improve insulin
delivery.
 Technological advances have transformed today’s pumps and
controllers into data collection centers. As additional data from
continuous glucose monitoring devices becomes more widely used,
the value of this data becomes even greater.
 Data needed for clinical monitoring and decisions is available in
today’s pump and can be accessed through screen displays, alerts,
or recommendations. Using routine monitoring techniques and data
analyses, a pump can inform the wearer regarding their current
control and changes in control.
These Mechanical Standards Are
Supported By:
 John Walsh, PA, CDE
 Ruth Roberts, MA
 Gary Scheiner, MS, CDE
 Timothy Bailey, MD, FACE
 Steve Edelman, MD
 Carol Wysham, MD
 Joseph Largay, PA, CDE
 David Horwitz, MD
 Etc

* Reservations by a signatory about a standard will be noted

Definitions
 TDD – total daily dose of insulin (all basals and boluses)
 Basal –background insulin pumped slowly through the day
to keep BG flat
 Bolus – a quick surge of insulin as
 Carb boluses to cover carbs

 Correction boluses to lower high readings that arise from

too little basal insulin delivery or insufficient carb boluses

 Bolus On Board (BOB) – the units of bolus insulin with
glucose-lowering activity still working from recent boluses
 Duration of Insulin Action (DIA) – time that a bolus will
lower the BG. This is used to calculate BOB.
Why Insulin Pump Guidelines Are Needed

These mechanical standards are designed to improve:

– Consistency of pump settings between pump manufacturers
– Accuracy and safety of carb and correction factor increments
– Safety and consistency of DIA defaults and increments
– Consistency in the handling of BOB and insulin stacking
– Improved monitoring for hypoglycemia & hyperglycemia
– Improved entry of glucose values into bolus calculations
– Faster notification of excessive use of correction boluses
– Faster identification of control problems related to infusion sets
Overview
Slides are numbered by topic for easy reference.
# Topic
– Carb Factor Increments
– Correction Factor Increments
– Carb Factor Accuracy
– Correction Factor Accuracy
– DIA Default Times
– DIA Time Increments
– Handling Of BOB
# Topic
8. Multi-Linear And Curvilinear DIA
9. Hypoglycemia Alert
10. Hyperglycemia Alert
11. Correction Bolus Alert
12. Insulin Stacking Alert
13. Automatic Entry Of BG Values
14. Infusion Set Monitoring
Review
What % of The TDD Changes The BG?
To understand some slides that follow, it helps to know the
significance of the effect that a change in the TDD has on
the glucose level.
Using a 450 Rule to set the carb factor and a 2000 Rule to
set the correction factor:
 1.25% of an appropriate TDD for an individual is sufficient to
change the glucose about 25 mg/dl when given as a single dose
 A 5% change in the TDD is equivalent to about a 25 mg/dl
increase or decrease in the glucose through the day
 A 5 to 6% change in the carb factor (about 2.5% to 3% of the
TDD) is sufficient to change the glucose about 20 mg/dl per
meal.
 1

Carb Factor Increments

 1
Standard For:
Carb Factor Increments
Carb factor increments shall be less than or equal to 5% of
the next larger whole number so that each single step
adjustment causes subsequent carb boluses to change by
no more than 5% from previous doses.
We recommend minimum carb factor increments of: 5
1.0 g/u above 20 g/u
0.5 g/u for 10 to 20 g/u
0.2 g/u for 5 to 9.8 g/u
0.1 g/u for 3 to 4.9 g/u
0.05 g/u for 0.1 to 2.95 g/u
5
Improved carb factor increments recommended by Gary Scheiner, MS, CDE
 1
Carb Factor (CarbF) Increments
Issue: Current carb factor increments are too large
to provide accurate carb boluses, especially for
those who use smaller carb factors. This can
represent a safety issue in situations where
current carb factors lack the precision required
to avoid excessive hyperglycemia and
hypoglycemia.
Example 1
Carb Factor Increments
 Most pumps offer 1 gram per unit as their smallest
CarbF increment. This increment becomes relatively
large for CarbFs below 15 or 20 g/u.
 For instance, when the carb factor is reduced from 10 to
9 g/u, all subsequent carb boluses are increased by
11.1%. A shift in the carb factor from 1u/5g to 1u/4g
causes each subsequent carb bolus to increase by 25%.
 For most pump users, a change in the carb factor larger
than 5 or 6% would be expected to create more than a
20 mg/dl shift in the glucose following each meal.
Example 1
Impact On BG From CarbF Adjustments
This table shows the average additional fall in glucose after each meal of the day
when a carb factor is reduced from 10 grams per unit to 9 grams per unit
(for appropriate weight & TDD), and from 5 gr per unit to 4 gr per unit.
How A 1-Step Reduction In CarbF Impacts Avg. Postprandial BG

Change in Weight Avg Avg carb Change per Change in BG

CarbF (~TDD) Carb/day gms/meal meal per meal*

1/10 to 1/9 160 lb 220 gr 73 gr + 1.47 u - 73.3 mg/dl**

(~40 u) (CorrF = 50)

1/5 to 1/4 240 lb 330 gr 110 gr + 5.5 u - 110 mg/dl**

(~100 u) (CorrF = 20)

** Meals with higher carb intake would magnify these sample glucose changes

* Calculated as avg. carbs/day – avg. carbs/day X 1 X 2000

new carb factor old carb factor 3 TDD
Review 1
Median Carb Factor
In unpublished data from the Cozmo Data Analysis
Study:
 The median (middle) carb factor was 11.2 g/u
 Almost all pumpers used carb factors below 20 g/u
 40% or more use carb factors of 10 g/u.
 1
What Current Changes In CarbFs Do
Table shows how subsequent carb boluses are affected by a one-step reduction in the CarbF using different CarbF increments. Yellow
area shows values for most current pumps. Green areas show safer increments that impact subsequent boluses less than 5%.

Orig. CF CF step 1 g/u CF step 0.5 g/u CF step 0.2 g/u CF step 0.1 g/u CF step 0.05 g/u
20 5.26% 2.63% 1.05% 0.53% 0.26%
19 5.56% 2.78% 1.11% 0.56% 0.28%
18 5.88% 2.94% 1.18% 0.59% 0.29%
17 6.25% 3.13% 1.25% 0.63% 0.31%
16 6.67% 3.33% 1.33% 0.67% 0.33%
15 7.14% 3.57% 1.43% 0.71% 0.36%
14 7.69% 3.85% 1.54% 0.77% 0.38%
13 8.33% 4.17% 1.67% 0.83% 0.42%
12 9.09% 4.55% 1.82% 0.91% 0.45%
11 10.00% 5.00% 2.00% 1.00% 0.50%
10 11.11% 5.56% 2.22% 1.11% 0.56%
9 12.50% 6.25% 2.50% 1.25% 0.63%
8 14.29% 7.14% 2.86% 1.43% 0.71%
7 16.67% 8.33% 3.33% 1.67% 0.83%
6 20.00% 10.00% 4.00% 2.00% 1.00%
5 25.00% 12.50% 5.00% 2.50% 1.25%
4 33.33% 16.67% 6.67% 3.33% 1.67%
3 50.00% 25.00% 10.00% 5.00% 2.50%
2 100.00% 50.00% 20.00% 10.00% 5.00%
 2

Correction Factor Increments

 2
Standard For:
Correction Factor Increments
For similar reasons, correction factor increments shall be less than or
equal to 5% of the next larger whole number so that each single step
adjustment causes subsequent correction boluses to change by no more
than 5% from previous doses.
We recommend minimum correction factor increments of:
5.0 mg/dl per u above 80 mg/dl per u
2.0 mg/dl per u for 40 to 78 mg/dl per u
1.0 mg/dl per u for 20 to 39 mg/dl per u
0.5 mg/dl per u for 10 to 19.5 mg/dl per u
0.2 mg/dl per u for 5 to 9.8 mg/dl per u
0.1 mg/dl per u for 3 to 4.9 mg/dl per u
0.05 mg/dl per u for 0.1 to 2.95 mg/dl per u
 3

Carb Factor Accuracy

 3
Standard For:
Verification Of Carb Factor Accuracy
• Insulin pump companies shall record and publish each year the
carb factors used in insulin pumps returned for upgrade or repair.
This report will include sufficient numbers of pumps to ensure
statistical significance for commonly used carb factors between 5
and 20 grams per unit to ensure that pump training and clinical
followup are assisting in the selection of accurate carb factors.
• To improve accurate selection of carb factors, efforts shall be
undertaken to automate carb factor testing.
 3
Personal Carb Factors
Issue: Many carb factors used in insulin pumps
today are poorly tuned to the user’s need.
When a carb factor does not match an
individual’s need, other sources of error in
carb bolus calculations are significantly
magnified.
 Review 3
Carb Factors In Use 1
Avg. carb factors* for 468
consecutive Cozmo insulin
pump downloads (>126,000
boluses) are shown in blue
Note that they are NOT bell-shaped
or physiologic
10
People prefer “magic” numbers – 7,
7
115 10, 15, and 20 g/unit – for their
carb factors
20
* Determined directly from grams of
carb divided by carb bolus units for
each carb bolus

1 J. Walsh, D. Wroblewsk i, and TS Bailey: Insulin Pump Settings ￐ A Major Sourc e For Insulin Dose Errors ,
Diabe tes Technology Meeting 2007
 Review 3
Carb Factors In Use 1

MANY magic carb factors, shown

in blue, are inaccurate. A more
normal or physiologic
distribution is shown in green
Use of magic numbers creates
10 major, consistent bolus errors
7
that magnify other sources for
115 error

20

1 J. Walsh, D. Wroblewsk i, and TS Bailey: Insulin Pump Settings ￐A Major Sourc e For Insulin Dose Errors ,
Diabe tes Technology Meeting 2007
 4

Correction Factor Accuracy

 4
Standard For:
Verification Of Corr Factor Accuracy
• Insulin pump companies shall record and publish each year the
correction factors used in insulin pumps returned for upgrade or
repair. This report will include sufficient numbers of pumps to
ensure statistical significance for commonly used correction factors
between 20 and 80 mg/dl per unit to ensure that pump training and
clinical followup are assisting in the selection of accurate correction
factors.
• To improve accurate selection of correction factors, efforts shall be
undertaken to automate correction factor testing.
 4
Personal Correction Factors
Issue: Many correction factors used in insulin
pumps today are poorly tuned to the user’s
need. This inaccuracy significantly
magnifies other sources of error in
correction bolus calculations.
 Review 4
Correction Factors In Use 1

Avg. correction factors in use for

452 consecutive Cozmo insulin
pump downloads
Like carb factors, correction factors
in use are NOT bell-shaped or
10 physiologic. A more accurate
7
choice of correction factors
115 would create a bell-shaped
curve.
20 Users or clinicians appear to
frequently select “magic”
numbers for correction factors.

1 J. Walsh, D. Wroblewsk i, and TS Bailey: Insulin Pump Settings ￐A Major Sourc e For Insulin Dose Errors ,
Diabe tes Technology Meeting 2007
 5

DIA Default Times

 5
Standard For:
DIA Default Times
• Default duration of insulin action (DIA) times in current
pumps vary widely between 3 and 6 hours. For safety in
bolus calculations that depend on DIA, the DIA default
shall be set no shorter than 4.5 hours in pumps that
determine DIA in a linear fashion and no shorter than 5
hours in pumps that determine DIA in a curvilinear or
multi-linear fashion. These default times apply for the
rapid insulins (lispro, aspart, and glulisine) in use at this
time.
 5
DIA Default Time Settings
Issue: DIA measures the glucose-lowering activity of a carb
or correction bolus over time. Current default times for DIA
range from 3 to 6 hours in different pumps.
 The DIA is often considered another tool to “improve control”
rather than being set at an appropriate value and focusing on
more appropriate changes in basal rates or carb and correction
factors to improve control.
 A DIA that is too short allows excess unrecognized bolus insulin
to accumulate, usually in the afternoon and evening hours.
 Example: a bolus given at 7 am appears to have no activity after
10 am. If a high BG occurs 10 am, more bolus than needed will
be given. At lunch, the bolus will be excessive, regardless of the
BG at that time, creating a high likelihood of hypoglycemia.
Review 5
How Long Do Boluses Lower The BG?
 Numerous GIR studies show rapid insulins lower the glucose for 5
hours or more.
 With Novolog (aspart) at 0.2 u/kg (0.091 u/lb), 23% of glucose
lowering activity remained after 4 hours.12
 Another study found Novolog (0.2 u/kg) lowered the glucose for 5
hours and 43 min. +/- 1 hour.13
 After 0.3 u/kg or 0.136 u/lb of Humalog (lispro), peak glucose-
lowering activity was seen at 2.4 hours and 30% of activity remained
after 4 hours. 11
These times would be longer if the unmeasured basal suppression in
pharmacodynamic studies were accounted for.
11 From Table 1 in Humalog Mix50/50 product information, PA 6872AMP, Eli Lilly and Company, issued January 15, 2007.
12 Mudaliar S, et al: Insulin aspart (B28 Asp-insulin): a fast-acting analog of human insulin. Diabetes Care 1999; 22:1501-1506.
13 L Heinemann, et al: Time-action profile of the insulin analogue B28Asp. Diabetic Med 1996;13:683-684.
Review 5
Short DIAs Hide Bolus Insulin Activity
A short DIA time hides true BOB level and its glucose-lowering
activity. This can be a safety issue in that it:
 Leads to “unexplained” lows
 Leads to incorrect adjustments in basal rates, carb factors, and
correction factors
 Causes users to start ignoring their “smart” pump’s advice

An inappropriately long DIA time overestimates bolus insulin activity – this

leads to underdosing rather than overdosing on subsequent boluses.
DIA should be based on an insulin’s real action time.

Do NOT modify the DIA time to fix a control problem

 Review 5
Duration Of Insulin Action (DIA)

Accurate bolus
estimates require
Glucose-lowering

an accurate DIA.
DIA times shorter
Activity

than 4.5 to 7 hrs

may hide BOB
and its glucose
lowering activity

0 2 hrs 4 hrs 6 hrs

Review 5
DIA
Regular Large doses (0.3 u/kg = 30
u for 220 lb. person) of
“rapid” insulin in 18 non-
diabetic, obese people
Med. doses (0.2 u/kg = 20 u
for 220 lb. person)
This study suggests that
residual insulin activity
can lower glucose levels
for 7-8 hours

Apidra product handout, Rev. April 2004a

Review 5
Does Dose Size Affect DIA?
This graphic suggests that
smaller boluses do not
lower the BG as long as
larger boluses.
However, this may not be
true – see next 2 slides.
Size of the injected Humalog dose
for a 154 lb or 70 kg person:
0.05 u/kg = 3.5 u
0.1 u/kg = 7u
0.2 u/kg = 14 u
0.3 u/kg = 21 u

Woodworth et al. Diabetes. 1993;42(Suppl. 1):54A

Review 5
Pharmacodynamics Is Not DIA
 The DIA time entered into an insulin pump is
based on studies of insulin pharmacodynamics.
 However, the traditional method used to
determine the pharmacodynamics of insulin may
underestimate insulin’s true duration of action, as
shown in the next two slides.
Review
Pharmacodynamics Underestimates DIA 5
And Overestimates Impact Of Bolus Size
 To measure pharmaco-
dynamics, glucose clamp
studies are done in healthy
individuals (0.05 to 0.3 u/kg)
 Because there is no basal
suppression, this injected
insulin ALSO SUPPRESSES
normal basal release from the
pancreas (grey area in figure)
Review 5
Pharmacodynamic Time Does Not Equal DIA
After accounting for the lack of basal suppression,
 True DIA times become longer than the PD times derived in
traditional research
 If basal suppression activity is
accounted for, small boluses may
be found to have a longer DIA
than it currently appears, erasing
some of the apparent variation in
DIA related to bolus size
 Some of the apparent inter-
individual variation in pharmacodynamics may also
disappear
 6

DIA Time Increments

 6
Standard For:
DIA Time Increments

For safe and accurate estimates of residual BOB,

DIA time increments shall be no greater than 15
minutes.
 6
DIA Time Increments
Issue: Current DIA time increments vary from 15
minutes to 1 hour in different pumps
 When a pump’s DIA time is adjusted, large time
increments, such as 1 hr, can introduce large changes
in subsequent estimates of BOB.
 For example, when the DIA is reduced from 5 hours to
4 hours, subsequent BOB estimates are decreased
and recommendations for carb boluses are increased
by about 25%.
Review 6
Glucose Infusion Rate (GIR) Studies
Most GIR studies suggest that pharmacodynamic action
of insulin varies only about 25% to 40% between
individuals.
For a DIA time of 5 hr and 15 min, a 25% range is
equivalent to 1 hr and 20 min, such as from 4 hrs
and 30 min to 5hr and 50 min.
A pump that has 1 hr DIA increments would enable the
user to select only 1 or 2 settings within this
physiologic range, while a 30 min increment would
allow only 2 or 3 choices that are close to a
physiologic range.
 7

Handling Of BOB

Bolus On Board (BOB)

 7
Standard For:
Handling Of BOB
For safe and accurate BOB measurement:
 BOB measurements shall include all carb and
correction boluses given within the selected DIA
 When residual BOB is present at the time of a bolus,
the BOB shall be subtracted from both carb and
correction bolus recommendations.
 When BOB exceeds the current correction bolus need
or the current carb plus correction need, the user will be
alerted to how many grams of carb they need to eat.
[(BOB – correction & carb bolus need) X carb factor]
 7
Handling Of BOB
Issue: Current pumps differ significantly in what is counted
as BOB and in whether or not BOB is subtracted from
subsequent carb boluses.
Most insulin pumps assume that excess BOB does not
need to be taken into account when determining the
next carb bolus.
Though commonly determined in this way, the resulting
bolus dose recommendations can cause unexplained
and unnecessary insulin stacking and hypoglycemia.
Example 7
Insulin Stacking
With a bedtime BG of 173 mg/dl,
is there an insulin deficit or a carb deficit?

Bedtime BG
Correction = 173 mg/dl
Dessert

Dinner

6 pm 8 pm 10 pm 12 am
Review 7
Frequency Of Insulin Stacking
CDA1 Study Results
Of 201,538 boluses, 64.8% were
given within 4.5 hrs of a
previous bolus

4.5 hrs Although 4.5 hours may

underestimate true DIA, use
of this minimal DIA time
shows that some BOB is
present for MOST boluses

J. Walsh, D. Wroblewski, and TS Bailey: Dispar ate Bolus Rec ommendations In Insulin Pump Therap y.
AACE Meeting 2007
Review 7
Bolus On Board (BOB)
An accurate measurement of the glucose-lowering activity
that remains from recent boluses:
• Prevents insulin stacking
• Improves bolus accuracy
• Allows the current carb or insulin deficit to be
determined

aka: insulin on board, active insulin, unused insulin*

* Introduced as Unused Insulin in 1st ed of Pumping Insulin (1989)
Review 7
How Current Pumps Handle BOB
What’s In the BOB & What Is It Applied Against?
BOB Includes BOB Is Subtracted From
This Type Of Bolus This Type Of Bolus
Carb Correction Carb Correction

Animas 2020 Yes Yes No* Yes

Deltec Cozmo Yes Yes Yes Yes

Insulet Omnipod No Yes No Yes

Medtronic Paradigm Yes Yes No

Yes

* Except when BG
* “Yes” is generally safer is below target BG
Example 7
Unsafe BOB1 Handling
If a pump user gets frustrated with a high BG and they
overdose to speed its fall, or they exercise longer or
more intensely than anticipated, they can acquire a
significant excess in BOB.
In this situation, most current pumps recommend that a
bolus be given for all carb intake regardless of how
much BOB is actually present.
If BOB is greater than the correction bolus requirement at
the time, the pump’s bolus recommendation may
introduce a risk for hypoglycemia.

1
Pumping Insulin, 1st ed, 1989, Chap 12, pgs 70-73: The Unused Insulin Rule
 Example 7
Differences In Bolus Recommendations
The graphic shows how widely bolus recommendations vary from one
pump to another for the same situation.
Situation:
units BOB = 3.0 u and 30 gr.
of carb will be eaten
4
at these glucose levels
3

2 Carb factor = 1u / 10 gr
Corr. Factor = 1 u / 40
1 mg/dl over 100
Target BG = 100
0
60 90 120 150 180 210 240 mg/dl TDD = ~50 u
Deltec Cozmo Animas 1250 Medtronic 522

Omnipod bolus cannot be determined - it counts only correction bolus insulin as BOB
Review 7
Track BOB Or Carb Digestion?
For safety after meal and correction boluses, tracking the glucose-
lowering action of BOB is more important than accounting for the
glucose-raising action of digesting meal carbs:
 When a BG is taken after a meal, the BOB times the correction factor
ideally represents the maximum fall in glucose expected.
 Accounting for the impact of the BOB on the current glucose provides
the safest approach in the determination of bolus recommendations.
 Low glycemic index meals, gastroparesis, Symlin, and other issues may
counteract a predicted fall in glucose based on BOB, but the user can
more easily judge and remedy this situation than dealing with an
unknown excess of insulin.
 7
Exceptions To Usual Handling Of BOB
 When a second bolus is taken for an unplanned carb
intake or a desert that is consumed within 60 minutes*
or so of a meal bolus, BOB should not be taken into
account for the second bolus because the impact of the
first bolus cannot be accurately determined.
 Given that, it is wise to account for BOB as soon after a
meal as possible, such as within 60 to 90 minutes,* to
provide early warning if the bolus given was excessive
or inadequate.
Accounting for all BOB and applying it to subsequent boluses
is generally safer, although not always more accurate.

* Adjustable setting in pump/controller

 8

Multi-Linear And Curvilinear DIA

 8
Standard For:
Multi-Linear And Curvilinear DIA
Insulin pumps shall use either a 100% curvilinear
or a multi-linear method to improve accuracy and
consistency of BOB estimates.
 8
Linear And Curvilinear DIA
Issue: Pump manufacturers use at least 3 different
methods (100% curvilinear, 95% of curvilinear,
and straight linear) to measure DIA and BOB.
When a realistic DIA time is selected, a linear
determination of residual BOB will not be as
accurate as a curvilinear method that
incorporates the slow onset of insulin action and
its longer tailing off in activity. In most situations,
an accurate determination of insulin’s tailing
activity will be most important to the pump user.
 8
Linear And Curvilinear DIA Compared

Note how values for the

5 hr linear line in red
5 hr Linear and the thinner 5 hr
curvilinear line
5 hr 95% Curvilinear diverge in value at
several points along
the graph.

From Pumping Insulin, 4th ed., adapted fom Mudaliar et al: Diabetes Care, 22: 1501, 1999
Example 8
A Multi-Linear DIA
Use of a multi-linear method to measure DIA
improves accuracy. The next page shows a
triple-linear example for measurement of BOB.
Example 8
A Triple-Linear Approximation Of DIA
A triple-linear line in red
can more closely
5 hr Triple Linear approximate a
curvilinear DIA.
For a 5 hr DIA*:
1st 10%** – no change
Mid 65%** – fall 75%**
Last 25%** – fall 25%**
(** adjustable as
needed in device)

* % modification
suggested by Gary
Scheiner, MS, CDE
 9

Hypoglycemia Alert
 9
Standards For:
Hypoglycemia Alert
• Insulin pumps that store glucose and insulin dosing data
shall present this glucose control data in a readily
accessible form on the pump or controller.
• The pump shall alert the user when the glucose data
from their glucose monitor or continuous monitor
suggests they are experiencing frequent* or severe*
patterns of hypoglycemia.

* Adjustable settings in pump/controller

 9
Frequent/Severe Hypoglycemia Alert
Issue: Although most current insulin pumps
contain sufficient data to do so, pumps give
no warning to a user when they are
experiencing patterns of frequent or severe
hypoglycemia.
Example 9
Pump Screen Hypoglycemia Display 1

Weekly History – Low BGs

# of weeks 1 2 4 8

# BGs/week 23 25 28 32

% BGs/week < 22% 18% 11% 8%

50 mg/dl*
% BGs/week < 35% 27% 19% 16%
70 mg/dl*

Modified to % display per Gary Scheiner, MS, CDE

* Adjustable settings in pump/controller

Example 9
Pump Screen Hypoglycemia Display 2

Low BGs By Time Of Day For 1 Week*

Avg BGs for 1 week 23 (3.3/day)

Time Period 4a-10a 10a-4p 4a-10p 10p-4a

% BGs < 50 mg/dl* 57% 14% 0% 0%

% BGs/week < 70 mg/dl* 71% 28% 0% 14%

Modified to % display per Gary Scheiner, MS, CDE

* Adjustable settings in pump/controller

 10

Hyperglycemia Alert
 10
Standards For:
Hyperglycemia Alert
• Insulin pumps that store glucose and insulin dosing data
shall present this glucose control data in a readily
accessible form on the pump or controller.
• The pump shall alert the user when the glucose data
from their glucose monitor or continuous monitor
suggests they are experiencing patterns of frequent* or
severe* hyperglycemia.

* Adjustable settings in pump/controller

 10
Frequent/Severe Hyperglycemia
Issue: Although most current insulin pumps
contain sufficient data to do so, pumps give
no warning to a user when they are
experiencing patterns of frequent or severe
hyperglycemia.
Example 10
Pump Screen Hyperglycemia Display 1

Weekly History – High BGs

# of weeks 1 2 4 8

Avg BGs/week 23 25 28 32

% BGs/week > 26% 30% 29% 26%

180 mg/dl*
% BGs/week 17% 18% 22% 23%
>220 mg/dl*

Modified to % display per Gary Scheiner, MS, CDE

* Adjustable settings in pump/controller

Example 10
Pump Screen Hypoglycemia Display 2

Low BGs By Time Of Day For 4 Weeks*

# BGs for 4 weeks 112 (4.0/day)

Time Period 4a-10a 10a-4p 4a-10p 10p-4a

% BGs > 180 mg/dl* 1% 3% 4% 21%

% BGs/week > 220 mg/dl* 0% 2% 3% 18%

Modified to % display per Gary Scheiner, MS, CDE

* Adjustable settings in pump/controller

 11

Correction Bolus Alert

 11
Standard For:
Correction Bolus Alert
• Insulin pumps shall show in a readily accessible history
screen the percentage of the TDD that is used for
correction boluses over time.
• The insulin pump shall alert the wearer when they are
using more than 8%* of their TDD for correction bolus
doses in the most recent 4 day* period.

* Adjustable settings in pump/controller

 11
Correction Bolus Alert
Issue: Hyperglycemia is more common than
hypoglycemia for most people on insulin pumps.
When glucose levels consistently run high, many pump
users address the problem by giving frequent
correction boluses rather than correcting the core
problem through an increase in their basal rates or
carb boluses.
If the correction bolus % becomes excessive relative to
the TDD, this information is often not shown and no
alert is given regarding the possible excessive use
of correction boluses.
 12

Insulin Stacking Alert

Accurate accounting of BOB becomes more

important in those who experience frequent or
severe hypoglycemia, as well as those whose
average glucose levels are closer to normal
values.
 12
Standard For:
Insulin Stacking Alert
Insulin pumps shall alert the wearer when they are giving a
bolus and no glucose value has been entered in the pump.
This is especially necessary when the user has sufficient
insulin stacking* to significantly alter the bolus they would
otherwise give.
The alert is on by default once a DIA time is selected to
measure BOB, but may be turned off if the user desires.
* Such as when the BOB is greater than 1.25%** of the avg. TDD, sufficient to
change the glucose about 25 mg/dl. (** Adjustable setting in pump/controller
for a certain fall in glucose selected by the user or clinician)
 12
Insulin Stacking Alert
Issue: Pump users often bolus for carbs without
checking their glucose first. With no glucose
reading, the pump cannot account for BOB, nor
appropriately adjust a bolus for the BOB or the
current BG.
Even without a glucose test, data available in the pump
at the time of a bolus can determine whether
enough BOB is present to substantially change a
bolus dose. The pump can alert the user to this
unseen, substantial insulin stacking.
Example 12
Insulin Stacking or BOB Alert
When a carb bolus is planned without a recent BG check, but BOB is
more than 1.25%* of the average TDD (enough to cause about a
25 mg/dl drop in the glucose), the pump will recommend that the
wearer do a BG check due to the substantial presence of BOB.

For instance, for someone with:

Avg TDD 1.25%* of TDD
40 units 0.5 units
50 mg/dl per u (corr factor) X 0.5 u = 25 mg/dl

This individual would be alerted when they do not check their glucose
and want to give a bolus but have 0.5 u or more of BOB present.

* Adjustable in pump/controller for a reasonable degree of safety

 13

Automatic Entry Of BG Values

 13
Standard For:
Automatic Entry Of BG Values
For completion of the glucose history, improved
handling of BOB, and more accurate bolus
recommendations, insulin pumps shall be enabled
to have wireless or direct entry of BG test results
from a glucose meter.
Automatic glucose entry from two or more major
brands of meters is recommended to increase the
likelihood of insurance coverage for test strips.
 13
Automatic Entry Of BG Values
Issue: Pump users do not enter as many BG values into
their pump when readings must be entered manually
rather than having a glucose value automatically entered
from a meter.
When a glucose is checked but not entered, the lost data
cannot be used to account for BOB, warn of insulin
stacking (see #12), nor be used to analyze glucose
patterns and the frequency of hypoglycemia and
hyperglycemia.
Relatively normal and hypoglycemia values are less likely to
be entered manually, but are more likely to be influenced
by BOB.
Review 13
Automatic Entry Of BG Values
In a study of over 500 insulin pumps where BG values could
be entered either manually or automatically, users
entered 2.6 BG values per day manually, compared to
4.1 values per day for pumps in which glucose values
wre automatically entered. *
BOB could typically be taken into account for 1.5 additional
boluses per day with automatic entry of BG values.
When glucose values are not automatically entered, BOB
cannot be determined and bolus recommendations will
not be as accurate.

* J. Walsh, D. Wroblewski, T.S. Bailey: unpublished data

Review 13
Automatic Entry Of BG Values
Automatic entry of glucose values into pumps
offers a significant clinical advantage to users
because more boluses will be adjusted for high
and low BGs, and residual BOB is more likely to
taken into accout in bolus calculations.
Automatic entry of glucose values ensures a
greater degree of safety for those who
experience frequent or sever hypoglycemia, and
those whose glucose values are closer to
normal.
 14

Infusion Set Monitoring

 14
Standards For:
Infusion Sets
• Insulin pumps shall monitor and record in easily
accessible history the duration of infusion set usage
recorded as mean, median, and SD of time of use.
• Insulin pumps shall monitor and report average
glucose values in full and partial 24 hour* time intervals
between set changes with the ability to change the
observation interval, such as 1 to 30 set changes.*
• These steps allow the HCP and user to identify infusion
set problem from loss of glucose control and variations
in patterns of use.
* Adjustable setting in pump/controller
 14
Infusion Sets
Issue: A significant number of non-patch pump
wearers encounter infusion set problems.
These problems may arise from poor infusion
set design or inadequate site preparation.
Often the source for the randomly erratic
glucose readings that follow are difficult to
identify by a user or clinician.
Review 14
Infusion Set Failure
One common problem source for infusion set failure arises
when a Teflon infusion set comes loose beneath the
skin from movement or tugging. Some of the infused
insulin then leaks back to the skin surface resulting in
unexplained high readings.
A complete loss of glucose control is typically seen when an
infusion set is pulled out entirely.
Selecting the right infusion set plus good site technique,
especially taping the infusion line to the skin, can
significantly minimize the number of unexplained high
readings for many pump wearers.
 14
Why The Tubing Needs To Be Taped
Most problems with infusion sets come from loosening of
the Teflon under the skin, not from a complete pullout.
A 1” tape placed on the infusion line:
 Stops tugging on the Teflon catheter under the skin
 Prevents loosening of the Teflon catheter under the skin
 Avoids many “unexplained highs”
caused when insulin leaks back
to the skin surface
 Reduces skin irritation
 And prevents many pull outs
 14
Tape The Tubing

This helps prevent

 Tugging
 Irritation
 Bleeding
Examples 14
Lack Of Anchoring Of Sets
A review of dozens of pictures of
infusion sets online and pump
manuals finds that anchoring of
the infusion line with tape is rarely
recommended or practiced.

No tape!
Review 14
Infusion Set Monitor
Many pump wearers experience random
erratic readings until they change to a
different infusion set or start to anchor their
infusion lines with tape to stop line tugging.
However, insulin pumps offer no mechanism
for clinicians or pump users to detect who
may be having problems with their infusion
sets.
Tool 14
Infusion Set Monitor
Insulin pumps with direct BG entry can identify those
who may be having intermittent loss of glucose
control secondary to infusion set failure. The pump:
 Shows the average time and variation in time of use
between reservoir loads or use of the priming function.
 Shows average BGs for each full or partial 24* hour time
interval following set changes (indicated by the prime
function) over a various number of set changes* or as
soon as statistical significance is reached.

* Adjustable setting in pump/controller