NCT03217175

Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will consist of two study arms. Each arm will include a 24-96 hour outpatient run-in period prior to their exercise visit wearing the bi-hormonal bionic pancreas. In random order subjects will then complete two approximately 5-hour exercise visits, one wearing the bi-hormonal bionic pancreas and one wearing the insulin-only bionic pancreas.

Detailed description

Twenty subjects will participate in two experimental periods. Each will include a 24-96 hour outpatient run-in period prior to their exercise visit wearing the bi-hormonal bionic pancreas. This will allow the bionic pancreas to adapt to their diabetes management needs. After the run-in period is complete, the subjects will participate in an exercise visit during which they will arrive fasting and remain fasted until the visit is completed. Subjects will walk on a treadmill for up to 1 hour at a comfortable walking pace. Plasma glucose (PG) measurements will be performed frequently. In one experimental period the bionic pancreas will remain in the bihormonal configuration and will deliver glucagon as needed during the exercise visit. In the other experimental period the glucagon will be replaced with a placebo during the exercise visit. The two experimental periods will be performed in random order. The study will be performed in single-blind fashion in that the participant will not know whether the bionic pancreas glucagon pump is filled with glucagon or placebo during the exercise visits. The outpatient run-in period will always be with the bi-hormonal bionic pancreas delivering glucagon.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Bihormonal Bionic Pancreas	The glucagon pump will be filled with glucagon during the exercise visit
DEVICE	Insulin Only Bionic Pancreas	The glucagon pump will be filled with placebo during the exercise visit, and the bionic pancreas will operate in an insulin only mode.
DRUG	Glucagon	Glucagon will be given according to the algorithm in the bihormonal bionic pancreas
DRUG	Placebo	Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas

Timeline

• Start date: 2017-08-18
• Primary completion: 2018-03-09
• Completion: 2018-03-09
• First posted: 2017-07-13
• Last updated: 2019-12-11
• Results posted: 2019-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study