NCT02660242

The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This project focuses on development of new strategy for the prevention of exercise-associated hypoglycemia using mini-dose glucagon.

Detailed description

The primary objective of the protocol is to determine if the administration of mini-dose glucagon administered subcutaneously just before exercise produces better glucose stability than no adjustments for moderate intensity exercise in patients with Type 1 Diabetes (T1D). It will also be assessed whether mini-dose glucagon before exercise produces better glucose stability than basal insulin reductions or extra carbohydrate consumption. This is a randomized, 4-way crossover trial. The trial will include 16 participants who complete the study. Each participant will undergo four aerobic exercise sessions (in random order), with different strategies for glucose regulation: * Control Trial: Fasted exercise, no basal insulin reduction * Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate at 60 minutes before exercise, for the duration of the exercise) * Strategy 2: Fasted exercise, no basal adjustment + pre-exercise glucose tabs (buccal route-40 grams in total ) * Strategy 3: Fasted exercise, no basal adjustment + pre-exercise mini-dose glucagon (sc) In all 4 sessions, aerobic exercise will be performed in the fasted state (before a standardized meal) for 45 minuets at \~50-55% of the participant's per-determined aerobic capacity. The participant's pump will be blinded during the control trial, strategy 1, and strategy 3 and an injection of saline will be given during the control trial and strategy 1 so that participant is blinded to strategy. The primary outcome for this study will be the glycemic response during exercise and early recovery.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	G-Pen Mini™ (glucagon injection)	Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
OTHER	Glucose Tabs	Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
OTHER	Basal Insulin Reduction	Basal insulin reduction to 50% 5 minutes before the start of exercise.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-02-15
• Completion: 2017-02-15
• First posted: 2016-01-21
• Last updated: 2020-03-03
• Results posted: 2018-08-07

Locations

2 sites across 1 country: United States