MedTrace Logo

Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise

NCT03217175 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-12-11

Study results available
· View outcomes & findings →

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Steven J Russell, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2018-03-09
Completion
2018-03-09
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217175 on ClinicalTrials.gov