Trial Outcomes & Findings for Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise (NCT NCT03217175)
NCT ID: NCT03217175
Last Updated: 2019-12-11
Results Overview
Number of subjects discordant between insulin-only and bihormonal bionic pancreas visits for reaching plasma glucose less than 60 mg/dl for greater than 2 consecutive measurements
TERMINATED
NA
22 participants
1 day (last day of each study arm - exercise visit)
2019-12-11
Participant Flow
22 subjects signed the consent form and screened into the study. 5 subjects were randomized and participated in the outpatient run-in period for one arm. Only 2 subjects of those 5 completed the arm. No subjects completed both arms of the study.
Participant milestones
| Measure |
Bihormonal Bionic Pancreas First, Then Insulin-Only
Insulin-only bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).
Placebo: Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas
Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.
Glucagon: Glucagon will be given according to the algorithm in the bihormonal bionic pancreas
|
Insulin Only Bionic Pancreas First, Then Bihormonal
Insulin-only bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).
Placebo: Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas
Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.
Glucagon: Glucagon will be given according to the algorithm in the bihormonal bionic pancreas
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Bihormonal Bionic Pancreas First, Then Insulin-Only
Insulin-only bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).
Placebo: Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas
Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.
Glucagon: Glucagon will be given according to the algorithm in the bihormonal bionic pancreas
|
Insulin Only Bionic Pancreas First, Then Bihormonal
Insulin-only bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).
Placebo: Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas
Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.
Glucagon: Glucagon will be given according to the algorithm in the bihormonal bionic pancreas
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
1
|
Baseline Characteristics
Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise
Baseline characteristics by cohort
| Measure |
Whole Study
n=22 Participants
All subjects enrolled. The study was terminated before most subjects were able to be randomized.
|
|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
|
Duration of diabetes
|
21.4 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day (last day of each study arm - exercise visit)Population: The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.
Number of subjects discordant between insulin-only and bihormonal bionic pancreas visits for reaching plasma glucose less than 60 mg/dl for greater than 2 consecutive measurements
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 day (last day of each study arm - exercise visit)Population: The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.
The amount of time the subject's plasma glucose is less than 60 mg/dl during the exercise visit
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 day (last day of each study arm - exercise visit)Population: The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.
The lowest plasma glucose experienced during the exercise visit
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 day (last day of each study arm - exercise visit)Population: The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.
The area over the plasma glucose curve but less than the 60 mg/dl threshold during exercise visit (a measure of hypoglycemic exposure)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 day (last day of each study arm - exercise visit)Population: The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.
The time from the start of exercise to the first plasma glucose measurement \< 60 mg/dl that is reached
Outcome measures
Outcome data not reported
Adverse Events
Bihormonal Bionic Pancreas
Insulin-only Bionic Pancreas
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Courtney Balliro, BS, RN, CDE
MGH Diabetes Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place