NCT02882737

The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This project is part of several studies exploring situations, where glucagon potential has lesser glucose elevating effect. Exercise can be one of these situations as exercise may reduce liver glycogen depots. The investigators aims are: 1. To compare the increase in plasma glucose after 200µg glucagon given either after exercise or after resting for 45 minutes. 2. To determine whether a subcutaneous glucagon injection just before exercise has a greater impact on hepatic glucose production and thereby is superior to an injection after exercise in preventing hypoglycemia during and two hours after exercise. 3. To compare the accuracy of two Dexcom G4 continuous glucose monitors, (CGM) placed at either the abdominal wall or on the upper arm.

Detailed description

Design: A randomized placebo-controlled single-blinded study will be conducted. The subjects do not know if they get glucagon or placebo but the investigator know if the subject get glucagon or placebo. Study participants have to complete three study days and serve as their own controls. After participants have given an informed consent, they will go through three steps: 1. Screening day 2. Run-in period 3. Three study days in a random order: * Exercise and glucagon injected after cycling/or during cycling in case of hypoglycemia * Resting and glucagon after resting * Exercise and glucagon subcutaneous before cycling 47-49 hours before the study visits one CGM device is placed on the abdominal wall on the participant at least 7 cm from the site of the insulin pump infusion set. One CGM is placed on the non-dominant upper arm between 10 cm from elbow and 10 cm from shoulder on the posterior/lateral side on the arm. The CGMs will be in place for seven days. The CGM readings on the CGM placed at the abdominal wall are not blinded for the participant. The CGM readings on the CGM placed on the arm is blinded for the participant. In the period from the study visits to 4 days after the study visits the participant will do self-monitoring of blood glucose 8 times a day on standardized times.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Glucagon before exercise
DRUG	Glucagon after exercise
DRUG	Glucagon after resting

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-07-11
• Completion: 2017-07-11
• First posted: 2016-08-30
• Last updated: 2017-07-24

Locations

1 site across 1 country: Denmark