Trial Outcomes & Findings for Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes (NCT NCT03093636)
NCT ID: NCT03093636
Last Updated: 2022-11-18
Results Overview
The primary efficacy outcome is increased % time within target range defined as CGM readings of 70-180 mg/dL.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-11-18
Participant Flow
A total of 111 individuals with T1D on MDI treatment were recruited: 55 at the University of Virginia, 25 at Stanford University, and 31 at the Icahn School of Medicine at Mount Sinai. Across all sites, 12 did not meet the inclusion criteria, and 19 dropped out or withdrew from the trial. The final sample included 80 participants: 23 participants were randomly assigned to the control group (MDI 1 CGM) and 57 to the experimental group (DSS 1 MDI 1 CGM).
Prior to randomization, the subject initiated a 2 weeks of home use of blinded CGM for characterization of baseline glycemic control and collection of baseline CGM data. The subject used carbohydrate counting per their usual routine with their usual home insulins during this time.
Participant milestones
| Measure |
Continuous Glucose Monitor (CGM)+Decision Support System (DSS)
Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App, study insulin, and study CGM at home for 12 weeks.
Continuous Glucose Monitor (CGM)+Decision Support System (DSS): Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App and a study CGM at home for 12 weeks. The DSS contains a "smart" bolus advisor that adjusts the size of the correction insulin boluses based on short-term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c. Subjects will use study basal and bolus insulin during the study.
|
Continuous Glucose Monitor (CGM) Alone
Continuous Glucose Monitor (CGM) alone study participants will use study insulin and the study CGM alone at home for 12 weeks.
Continuous Glucose Monitor (CGM) alone: Continuous Glucose Monitor (CGM) alone study participants will use a study CGM at home for 12 weeks. Subjects will use study basal and bolus insulin during the study.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
23
|
|
Overall Study
COMPLETED
|
57
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes
Baseline characteristics by cohort
| Measure |
Continuous Glucose Monitor (CGM)+Decision Support System (DSS)
n=57 Participants
Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App, study insulin, and study CGM at home for 12 weeks.
Continuous Glucose Monitor (CGM)+Decision Support System (DSS): Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App and a study CGM at home for 12 weeks. The DSS contains a "smart" bolus advisor that adjusts the size of the correction insulin boluses based on short-term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c. Subjects will use study basal and bolus insulin during the study.
|
Continuous Glucose Monitor (CGM) Alone
n=23 Participants
Continuous Glucose Monitor (CGM) alone study participants will use study insulin and the study CGM alone at home for 12 weeks.
Continuous Glucose Monitor (CGM) alone: Continuous Glucose Monitor (CGM) alone study participants will use a study CGM at home for 12 weeks. Subjects will use study basal and bolus insulin during the study.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.44 years
STANDARD_DEVIATION 14.15 • n=5 Participants
|
39.91 years
STANDARD_DEVIATION 16.06 • n=7 Participants
|
35.3 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
44 participants
n=5 Participants
|
21 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Americans
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Alaskan Indian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Baseline HbA1c %
|
7.41 Percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.18 • n=5 Participants
|
7.68 Percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.29 • n=7 Participants
|
7.49 Percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
Time since T1D diagnosis
|
15.85 years
STANDARD_DEVIATION 12.58 • n=5 Participants
|
15.26 years
STANDARD_DEVIATION 13.00 • n=7 Participants
|
15.68 years
STANDARD_DEVIATION 12.62 • n=5 Participants
|
|
Body Mass Index (BMI), kg/m2
|
27.42 kg/m^2
STANDARD_DEVIATION 5.77 • n=5 Participants
|
26.91 kg/m^2
STANDARD_DEVIATION 6.85 • n=7 Participants
|
27.27 kg/m^2
STANDARD_DEVIATION 6.06 • n=5 Participants
|
|
Total Daily Insulin, units/kg
|
0.71 units/kg/day
STANDARD_DEVIATION 0.26 • n=5 Participants
|
0.72 units/kg/day
STANDARD_DEVIATION 0.30 • n=7 Participants
|
.71 units/kg/day
STANDARD_DEVIATION .27 • n=5 Participants
|
|
Continuous Glucose Monitor naive
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Participants splitting basal insulin into two injections, %
|
22.9 percentage of participants
n=5 Participants
|
34.8 percentage of participants
n=7 Participants
|
26.3 percentage of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe primary efficacy outcome is increased % time within target range defined as CGM readings of 70-180 mg/dL.
Outcome measures
| Measure |
Continuous Glucose Monitor (CGM)+Decision Support System (DSS)
n=57 Participants
Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App, study insulin, and study CGM at home for 12 weeks.
Continuous Glucose Monitor (CGM)+Decision Support System (DSS): Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App and a study CGM at home for 12 weeks. The DSS contains a "smart" bolus advisor that adjusts the size of the correction insulin boluses based on short-term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c. Subjects will use study basal and bolus insulin during the study.
|
Continuous Glucose Monitor (CGM) Alone
n=23 Participants
Continuous Glucose Monitor (CGM) alone study participants will use study insulin and the study CGM alone at home for 12 weeks.
Continuous Glucose Monitor (CGM) alone: Continuous Glucose Monitor (CGM) alone study participants will use a study CGM at home for 12 weeks. Subjects will use study basal and bolus insulin during the study.
|
|---|---|---|
|
% Time Within Target Range
|
57.7 percentage of time in range
Standard Deviation 16.3
|
58.2 percentage of time in range
Standard Deviation 18.8
|
Adverse Events
Continuous Glucose Monitor (CGM)+Decision Support System (DSS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Glucose Monitor (CGM) Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marc Breton, PhD
University of Virginia Center for Diabetes Technology
Phone: (434) 982-6484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place