Evaluation of the Uptake of a Novel Tool

to Adjust Insulin Boluses Based on CGM

Trend Arrows and Insulin Sensitivity
(CGM TIME Trial Trend Arrow Adjustment Tool)
E. Heffernan1,2
M. L. Lawson1,2
C. Richardson2, J. Courtney2, B. Bradley2
JDRF Canadian Clinical Trial Network CCTN1101 CGM TIME Trial
Study Group
1Childrens

Hospital of Eastern Ontario, Ottawa, Canada

2CHEO Research Institute, Ottawa, Canada

Presenter Disclosure Information

Dr Emmeline Heffernan
Research Support:
JDRF Canadian Clinical Trial Network (CCTN)
Postdoctoral Fellowship in Clinical Translation in T1D

Background
CGM provides 288 glucose levels per day,
updated every 5 minutes,
displayed in real time.
But ACTING on information is required
CGM data interpretation can be difficult3
CGM use decreases over time & A1C rises1,4
Pediatric studies: demonstrate need to use CGM at least
6/7 days for improvement in A1C1,2

1JDRF

CGM Study Group, 2008 2Kordonouri et al, 2010

3DirectNet Study Group, 2008 4Jenkins et al 2010

CGM trend arrows

Provide dynamic data

Allow proactive adjustments to insulin
most helpful feature in a survey by T1D Exchange
(92% CGM users indicated arrows were helpful)5
However effective strategies for adjusting insulin based
on trend arrows are lacking
Adults reported in an online survey they would make
adjustments of 11-81%6

5Wong

et al, 2014 6Pettus et al, 2014

CGM
Arrows

Interpretation of Arrows

Glucose is increasing by 1-2 mmol/L over 20 min

(1-2 mg/dl/min)

Glucose is increasing by > 2 mmol/L over 20 min

(> 2 mg/dl/min)

Glucose is decreasing by 1-2 mmol/L over 20 min

(1-2 mg/dl/min)

Glucose is decreasing by > 2 mmol/L over 20 min

(> 2 mg/dl/min)

CGM
Trend
Arrows

STAR 1 Trial and JDRF

CGM Study Group

CGM Time Trial

Adjustment Tool
based on
Insulin Sensitivity

Add 10% to bolus

Add ____ units

(1.5ISF=1.5___=___)

Add 20% to bolus

Add ____ units

(3.0ISF=3.0 ___=___)

Subtract 10% from bolus

Subtract ____ units

(1.5ISF=1.5 ___=___)

Subtract 20% from bolus

Subtract ____ units

(3.0ISF=3.0 ___=___)

CGM Trend
Arrows

STAR 1 Trial and JDRF

CGM Study Group

CGM Time Trial

Adjustment Tool based
on Insulin Sensitivity
ISF = 3

Add 10% to bolus

Add 0.5 units

(1.5ISF=1.5 3 = 0.5)

Add 20% to bolus

Add 1 units
(3.0ISF=3.0 3 = 1)

Subtract 10% from bolus

Subtract 0.5 units

(1.5ISF=1.5 3 = 0.5)

Subtract 20% from bolus

Subtract 1 units
(3.0ISF=3.0 3 = 1)

Comparison of JDRF CGM Study Group and

TIME Trial Trend Arrow Adjustment Tools
Example:
I:CHO = 1:10
ISF = 5
Target BG = 6

JDRF CGM Study Group

10/20% adjustment

CGM TIME Trial Trend

Arrow Adjustment Tool
based on ISF

40g CHO
Total Bolus = 5.28 units
BG 8 mmol/L
(144mg/dl)
0.88 units for 2 arrows up
CGM shows

Total Bolus = 5.0 units

80 g CHO
Bolus wizard: 10.4 units
BG 18 mmol/L Add 20% for
(324mg/dl)
2.08 units for 2 arrows up
CGM shows
Total Bolus = 12.48 units

Bolus wizard: 10.4 units

Add 0.6 for
0.6 units for 2 arrows up

0.6 units for 2 arrows up

Total Bolus = 11.0 units

The CGM TIME Trial:

Timing of Initiation of Continuous Glucose
Monitoring in Established Pediatric Diabetes
Multicentre study: CHEO, London Childrens Hospital,
McMaster, Sickkids, Markham-Stouffville
5-18 year olds with T1D > 1 year; nave to pump
therapy
144 children/youth randomized to simultaneous pump
+ CGM or standard pump therapy with addition of
CGM at 6 months
Current BG is 4.3
Primary outcome 12 months (fall 2014)

Population characteristics

Age (yrs)

Gender

Race

Simultaneous
CGM

Delayed CGM Overall

20

20

40

Mean

12.4

12.03

12.07

SD

3.41

3.26

3.29

Male

13 (65%)

10 (50%)

23 (57.5%)

Female

7 (35%)

10 (50%)

17 (42.5%)

White

19 (95%)

15 (75%)

34 (85%)

Other

1 (5%)

5 (25%)

6 (15%)

4.5

3.9

4.2

Mean

7.94%

8.1%

7.87%

SD

1.06%

0.92%

0.98%

Diabetes
duration (yrs)
HbA1c

Evaluation of Uptake & Use of TAAT

Retrospective audit of 40 CHEO participants in CGM
TIME Trial
Objectives:
To determine the uptake and frequency of use of TAAT
To determine whether use was sustained over 6 months
To determine details of use
Methods:
CareLink data reviewed - at CGM initiation
- 3 months
- 6 months

% Subjects using TAAT

CGM start

Frequency of TAAT use

1.2

Number
of uses
per
week

0.93

0.8
0.6

1.02

0.73

0.4
0.2
0

6 weeks

CGM start

3 months

6 months

Details of TAAT use

Conclusion
TAAT uptake was high (87.5%) & sustained over 6
months following CGM initiation (73%)
Frequency of use was variable; subjects used TAAT to
avoid low & high sugars; most frequently used in
evenings

A prospective study is underway to evaluate the effect of

TAAT on postprandial glycemic control, ease of use and
patient satisfaction

Acknowledgements
I would like to thank JDRF and the Canadian Clinical
Trials Network
I am particularly grateful to JDRF-UK and the Gillespie
Family for their special support, in honour of Ruth
Gillespie.