Trial Outcomes & Findings for The Set-Point Study for Type 2 Diabetes: Evaluating the Use of an Insulin Only Bionic Pancreas System in Type 2 Diabetes (NCT NCT03552523)

NCT ID: NCT03552523

Last Updated: 2019-09-10

Results Overview

Average glucose value from the information collected by the Dexcom CGM device during the control and experimental arms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: days 2-7
• Results posted on: 2019-09-10

Participant Flow

16 subjects consented and were screened for eligibility. 7 subjects were ineligible. Of the 9 that were eligible, 2 subjects were eligible but not able to schedule their study participation. The other 7 eligible subjects were randomized and started participating in the trial. 5 of those 7 subjects completed both arms of the study.

Participant milestones

Measure	Usual Care First Then Bionic Pancreas Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections. Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.	Bionic Pancreas First Then Usual Care Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter. Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.
Overall Study STARTED	5	2
Overall Study COMPLETED	4	1
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Usual Care First Then Bionic Pancreas Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections. Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.	Bionic Pancreas First Then Usual Care Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter. Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

The Set-Point Study for Type 2 Diabetes: Evaluating the Use of an Insulin Only Bionic Pancreas System in Type 2 Diabetes

Baseline characteristics by cohort

Measure	All Enrolled Subjects n=16 Participants All enrolled subjects
Age, Continuous	48.7 years STANDARD_DEVIATION 29.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
Hemoglobin A1c	8.2 percent STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: days 2-7

Population: Only completed study arms are analyzed. 7 subjects started participating, but only 5 subjects completed both study arms. 2 subjects withdrew during the first study arm.

Average glucose value from the information collected by the Dexcom CGM device during the control and experimental arms.

Outcome measures

Measure	Usual Care n=5 Participants Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections. Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.	Bionic Pancreas n=5 Participants During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter. Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.
Mean Dexcom CGM Glucose (CGMG) Level	152.8 mg/dl Standard Deviation 21.3	137.1 mg/dl Standard Deviation 7.5

PRIMARY outcome

Timeframe: days 2-7

Population: Only completed study arms are analyzed. 7 subjects started participating, but only 5 subjects completed both study arms. 2 subjects withdrew during the first study arm.

Using glucose information collected from the Dexcom device we will establish percentage of time spent in a hypoglycemia threshold range

Outcome measures

Measure	Usual Care n=5 Participants Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections. Usual Care: Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.	Bionic Pancreas n=5 Participants During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter. Bionic Pancreas: During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.
Average Time Spent With CGMG Less Than 54 mg/dl	0.10 percentage of time Standard Deviation 0.22	0.21 percentage of time Standard Deviation 0.47

Adverse Events

Bionic Pancreas

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Courtney Balliro

MGH Diabetes Research Center

Phone: 617-726-1242

Email: cballiro@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place