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

• Status: Completed
• Trial end date: 2017-07-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Collaborator: Technical University of Denmark
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• Type 1 Diabetes ≥ 2 year

• BMI 20-30 kg/m2

• Insulin pump ≥ 1 year.

• HbA1c < 69 mmol/mol (8.5 %)

• Hypoglycemia awareness (reported by Gold et al.)

• Use of carbohydrate counting and the insulin pump bolus calculator for all meals

• Sedentary or mild physical activity: Less than 150 minutes of moderate-intensity aerobic physical activity throughout the week and less than 75 minutes of vigorous-intensity aerobic physical activity throughout the week .

Exclusion Criteria:

• Allergy or intolerance to lactose or GlucaGen® (Novo Nordisk, Bagsværd, DK)

• Impaired renal function (eGFR < 60 ml/min/1.73m2)

• Liver disease with ALAT > 2.5 times the upper limit of the reference interval

• Use of anti-diabetic medicine (other than insulin), per oral corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start

• Known or suspected alcohol or drug abuse

• Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation

• Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods

• Inability to understand the patient information and to give informed consent

• Physical or mental incapacity to perform exercise

• Chronic use or unable to stop acetaminophen (paracetamol) use

• Allergy to the patch of CGM