Trial Outcomes & Findings for Adaptive Biobehavioral Control (ABC) in a Closed-Loop System (NCT NCT05610111)
NCT ID: NCT05610111
Last Updated: 2026-07-07
Results Overview
The primary outcome for this study is CGM-measured percent time in range 70-180 mg/dL over the last 4-week periods on CLC+ABC versus 2 weeks of the current CLC system.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
Results posted on
2026-07-07
Participant Flow
73 participants were randomized but 1 participant from the "CLC+ABC, then CLC+BAM, then CLC" arm did not complete the study. 72 participants completed.
Participant milestones
| Measure |
CLC, Then CLC+BAM, Then CLC+ABC
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
35
|
|
Overall Study
COMPLETED
|
38
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
CLC, Then CLC+BAM, Then CLC+ABC
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Adaptive Biobehavioral Control (ABC) in a Closed-Loop System
Baseline characteristics by cohort
| Measure |
CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 15.5 • n=20 Participants
|
44.1 years
STANDARD_DEVIATION 14.7 • n=20 Participants
|
42.8 years
STANDARD_DEVIATION 15.1 • n=40 Participants
|
|
Sex/Gender, Customized
Female
|
27 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Male
|
9 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Not disclosed
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
66 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=20 Participants
|
31 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Weight (kg)
|
83.2 kg
STANDARD_DEVIATION 21.3 • n=20 Participants
|
82.1 kg
STANDARD_DEVIATION 16.2 • n=20 Participants
|
82.7 kg
STANDARD_DEVIATION 18.9 • n=40 Participants
|
|
Height (cm)
|
168.7 cm
STANDARD_DEVIATION 10.2 • n=20 Participants
|
167.2 cm
STANDARD_DEVIATION 8.4 • n=20 Participants
|
168.0 cm
STANDARD_DEVIATION 9.4 • n=40 Participants
|
|
Screening glycated hemoglobin (%)
|
6.7 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.7 • n=20 Participants
|
6.8 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.8 • n=20 Participants
|
6.8 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.8 • n=40 Participants
|
PRIMARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCThe primary outcome for this study is CGM-measured percent time in range 70-180 mg/dL over the last 4-week periods on CLC+ABC versus 2 weeks of the current CLC system.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
CGM-measured Percent Time in Range 70-180 mg/dL
|
72.26 percentage of time in range
Standard Deviation 12.65
|
72.49 percentage of time in range
Standard Deviation 11.77
|
76.80 percentage of time in range
Standard Deviation 9.20
|
77.91 percentage of time in range
Standard Deviation 10.41
|
77.93 percentage of time in range
Standard Deviation 9.40
|
78.03 percentage of time in range
Standard Deviation 10.52
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCA key secondary outcome is CGM-measured percent above 180mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
CGM-measured Percent Above 180 mg/dL During the Day
|
26.84 percentage of time
Standard Deviation 13.63
|
27.57 percentage of time
Standard Deviation 12.81
|
22.34 percentage of time
Standard Deviation 9.52
|
20.81 percentage of time
Standard Deviation 9.70
|
21.01 percentage of time
Standard Deviation 9.40
|
21.00 percentage of time
Standard Deviation 10.55
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCA key secondary outcome is CGM-measured percent below 70mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
CGM-measured Percent Below 70 mg/dL During the Day
|
1.68 percentage of time
Standard Deviation 1.74
|
1.68 percentage of time
Standard Deviation 1.50
|
1.98 percentage of time
Standard Deviation 1.62
|
1.90 percentage of time
Standard Deviation 1.27
|
2.09 percentage of time
Standard Deviation 1.57
|
1.97 percentage of time
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCA key secondary outcome is CGM-measured mean glucose comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
CGM-measured Mean Glucose
|
154.58 mg/dL
Standard Deviation 20.98
|
153.94 mg/dL
Standard Deviation 19.69
|
147.06 mg/dL
Standard Deviation 13.20
|
145.08 mg/dL
Standard Deviation 14.36
|
144.83 mg/dL
Standard Deviation 13.71
|
144.53 mg/dL
Standard Deviation 15.21
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCA key secondary outcome is CGM-measured percent coefficient of variation during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
CGM-measured Coefficient of Variation During the Day
|
33.04 percentage
Standard Deviation 4.77
|
33.42 percentage
Standard Deviation 3.87
|
33.71 percentage
Standard Deviation 5.29
|
32.30 percentage
Standard Deviation 5.58
|
33.33 percentage
Standard Deviation 5.56
|
31.68 percentage
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCA key secondary outcome is CGM-measured time in range from 70-140 mg/dL comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
Time in Range (70-140 mg/dL)
|
49.69 percentage of time
Standard Deviation 14.11
|
46.81 percentage of time
Standard Deviation 12.92
|
51.62 percentage of time
Standard Deviation 9.99
|
53.16 percentage of time
Standard Deviation 13.36
|
53.79 percentage of time
Standard Deviation 12.33
|
53.24 percentage of time
Standard Deviation 13.94
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCTime below 60 mg/dL as measured by CGM.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
TIR <60 mg/dL
|
0.61 percentage of time
Standard Deviation 0.84
|
0.71 percentage of time
Standard Deviation 0.73
|
0.79 percentage of time
Standard Deviation 0.75
|
0.74 percentage of time
Standard Deviation 0.58
|
0.86 percentage of time
Standard Deviation 0.77
|
0.80 percentage of time
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCThe low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values \<1 suggest low risk of hypoglycemia.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
Low Blood Glucose Index (LBGI)
|
2.74 index
Standard Deviation 1.48
|
2.79 index
Standard Deviation 1.46
|
3.19 index
Standard Deviation 1.19
|
3.28 index
Standard Deviation 1.35
|
3.34 index
Standard Deviation 1.14
|
3.24 index
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCThe high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
High Blood Glucose Index (HBGI)
|
2.01 index
Standard Deviation 1.10
|
1.98 index
Standard Deviation 0.98
|
1.71 index
Standard Deviation 0.67
|
1.56 index
Standard Deviation 0.60
|
1.65 index
Standard Deviation 0.52
|
1.61 index
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCTime above 250 mg/dL as measured by CGM.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
TIR >250 mg/dL
|
6.90 percentage of time
Standard Deviation 7.06
|
6.64 percentage of time
Standard Deviation 6.17
|
4.91 percentage of time
Standard Deviation 4.28
|
4.24 percentage of time
Standard Deviation 3.54
|
4.42 percentage of time
Standard Deviation 3.54
|
3.82 percentage of time
Standard Deviation 3.89
|
SECONDARY outcome
Timeframe: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABCTime above 300 mg/dL as measured by CGM.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
TIR >300 mg/dL
|
2.41 percentage of time
Standard Deviation 3.29
|
2.32 percentage of time
Standard Deviation 2.96
|
1.57 percentage of time
Standard Deviation 2.06
|
1.17 percentage of time
Standard Deviation 1.38
|
1.40 percentage of time
Standard Deviation 1.49
|
1.00 percentage of time
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Labs taken at the completion of study, approximately 6 months after enrollment; hence, results are stratified only by arm and not by intervention.The percentage of glycated hemoglobin. A higher percentage indicates a worse outcome.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=34 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
HbA1c (%) at End of Study
|
6.6 percentage of glycated hemoglobin
Standard Deviation 0.6
|
6.6 percentage of glycated hemoglobin
Standard Deviation 0.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Participant baselinePopulation: This assessment is administered at Baseline, prior to start of the intervention sequence.
This questionnaire is rated on a 5-point Likert scale and is the baseline version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance).
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=35 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
Technology Expectations Survey
|
3.61 score on a scale
Standard Deviation 0.58
|
3.93 score on a scale
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 22 weeksNumber of individuals with hypoglycemia awareness, reduced hypoglycemia awareness, and in between, based on Clarke's Hypoglycemia Awareness Scale.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
Clarke's Hypoglycemia Awareness Scale
Unaware
|
18 Participants
|
17 Participants
|
19 Participants
|
11 Participants
|
11 Participants
|
13 Participants
|
|
Clarke's Hypoglycemia Awareness Scale
Aware
|
16 Participants
|
15 Participants
|
11 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
|
Clarke's Hypoglycemia Awareness Scale
Uncertain
|
4 Participants
|
6 Participants
|
8 Participants
|
15 Participants
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: At participant completion, approximately 6 monthsThis questionnaire is rated on a 5-point Likert scale and is the endpoint version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance). The score is not reported for CLC only, as no technology was used during this intervention.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=34 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
Technology Experience Survey
|
3.49 score on a scale
Standard Deviation 0.61
|
3.71 score on a scale
Standard Deviation 0.81
|
3.81 score on a scale
Standard Deviation 0.66
|
3.86 score on a scale
Standard Deviation 0.73
|
—
|
—
|
SECONDARY outcome
Timeframe: 22 weeksThis questionnaire evaluates generalized avoidance of hyperglycemia across 4 subcategories using items rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hyperglycemia avoidance and worry. The total score reported is obtained by averaging the scores of all the items in the survey.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
High Blood Glucose Levels Survey
|
1.71 score on a scale
Standard Deviation 0.46
|
1.68 score on a scale
Standard Deviation 0.47
|
1.71 score on a scale
Standard Deviation 0.48
|
1.71 score on a scale
Standard Deviation 0.48
|
1.62 score on a scale
Standard Deviation 0.35
|
1.66 score on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: 22 weeksThis questionnaire evaluates Fear of Hypoglycemia and each item is rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hypoglycemia fear and worry. The total score reported is obtained by averaging the scores of all the items in the survey.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
Hypoglycemia Fear Survey
|
1.90 score on a scale
Standard Deviation 0.51
|
1.93 score on a scale
Standard Deviation 0.51
|
1.95 score on a scale
Standard Deviation 0.57
|
1.83 score on a scale
Standard Deviation 0.45
|
1.79 score on a scale
Standard Deviation 0.43
|
1.77 score on a scale
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 22 weeksA questionnaire evaluating different domains of diabetes-related distress. Each item is scored on a 6 point Likert scale. Range is 1-6- with scores of 2-2.9 indicating moderate distress and scores \> 3.0 indicating severe distress. The total score reported is obtained by averaging the scores of all the items in the survey.
Outcome measures
| Measure |
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.
CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
n=38 Participants
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
n=34 Participants
Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
|
|---|---|---|---|---|---|---|
|
Diabetes Distress Scale
|
1.95 score on a scale
Standard Deviation 0.70
|
1.91 score on a scale
Standard Deviation 0.72
|
1.80 score on a scale
Standard Deviation 0.65
|
1.79 score on a scale
Standard Deviation 0.61
|
1.76 score on a scale
Standard Deviation 0.49
|
1.81 score on a scale
Standard Deviation 0.63
|
Adverse Events
CLC of: CLC, Then CLC+BAM, Then CLC+ABC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CLC of: CLC+ABC, Then CLC+BAM, Then CLC
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
Boris Kovatchev, PhD
UVA Center for Diabetes Technology
Phone: 434-924-5592
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place