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Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise

Type 1 Diabetes Mellitus Clinical Trial

Official title:
Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03217175
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Terminated
Phase N/A
Start date August 18, 2017
Completion date March 9, 2018
View Details
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