Trial Outcomes & Findings for Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery (NCT NCT04784637)
NCT ID: NCT04784637
Last Updated: 2024-11-07
Results Overview
Safety assessment of ATM / WST and BAM modules by assessing serious adverse events or adverse device effects deemed related to the use of ATM/WST and BAM modules specifically.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-11-07
Participant Flow
31 participants signed a consent which was defined as enrollment in the protocol. 1 participant withdrew after signing the consent due to personal scheduling issues and 30 participants were randomized and reported in study results.
Participant milestones
| Measure |
Group 1
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery
Baseline characteristics by cohort
| Measure |
Group 1
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12 • n=5 Participants
|
38 years
STANDARD_DEVIATION 16 • n=7 Participants
|
40 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Total Daily Insulin
|
47.6 units per day
STANDARD_DEVIATION 29.9 • n=5 Participants
|
45.6 units per day
STANDARD_DEVIATION 19.8 • n=7 Participants
|
46.6 units per day
STANDARD_DEVIATION 24.9 • n=5 Participants
|
|
Duration of Diabetes
|
23 years
STANDARD_DEVIATION 13 • n=5 Participants
|
23 years
STANDARD_DEVIATION 15 • n=7 Participants
|
23 years
STANDARD_DEVIATION 14 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksSafety assessment of ATM / WST and BAM modules by assessing serious adverse events or adverse device effects deemed related to the use of ATM/WST and BAM modules specifically.
Outcome measures
| Measure |
Group 1
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2 Baseline
Two weeks of baseline measures
|
Group 2 Post Randomization
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
|---|---|---|---|---|
|
Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules.
|
0 events
|
0 events
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPercent of CGM readings in the target ranges of 70-180mg/dL from 2 weeks of baseline compared to last 2 weeks of treatment period.
Outcome measures
| Measure |
Group 1
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2 Baseline
n=15 Participants
Two weeks of baseline measures
|
Group 2 Post Randomization
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
|---|---|---|---|---|
|
Time in Range
|
77.0 percentage of time
Standard Deviation 11.6
|
73.8 percentage of time
Standard Deviation 8.1
|
74.6 percentage of time
Standard Deviation 9.4
|
74.6 percentage of time
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 6 weeksPercent of CGM readings \<70 mg/dL
Outcome measures
| Measure |
Group 1
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2 Baseline
n=15 Participants
Two weeks of baseline measures
|
Group 2 Post Randomization
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
|---|---|---|---|---|
|
Time in Hypoglycemia
|
2.35 percentage of time
Standard Deviation 1.98
|
1.41 percentage of time
Standard Deviation 1.33
|
1.58 percentage of time
Standard Deviation 1.71
|
1.48 percentage of time
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: 6 weeksQuestionnaire addressing system/technology use. The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items.
Outcome measures
| Measure |
Group 1
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
Group 2 Baseline
n=15 Participants
Two weeks of baseline measures
|
Group 2 Post Randomization
n=15 Participants
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
|
|---|---|---|---|---|
|
INSPIRE Questionnaire
|
77 score on a scale
Standard Deviation 12
|
74 score on a scale
Standard Deviation 8
|
75 score on a scale
Standard Deviation 9
|
75 score on a scale
Standard Deviation 9
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place