Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

Steno Diabetes Centers

Status: Completed

Conditions: Hypoglycemia; Type 1 Diabetes

Treatments: Drug: Saline; Drug: GlucaGen

Study type: Interventional

Funder types: Other

Identifiers

NCT05076292

78618

2021-001342-34 (EudraCT Number)

Details and patient eligibility

About

The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).

The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and outpatient settings.

Full description

A randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. At every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo.

During the visits and in an outpatient period the participants will have 3 different CGM devices installed and the values will be compared with self-monitored blood glucose values.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• T1D ≥ 2 years
• Use of insulin pump or MDI therapy for ≥ 6 months
• Current use of insulin aspart
• HbA1c ≤ 70mmol/mol (8.5%)
• Body mass index (BMI) ≤ 30 kg/m2
• Performs exercise ≥1 time per week

Exclusion criteria

• Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
• Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week)
• Known or suspected allergies to glucagon or related products
• History of hypersensitivity or allergic reaction to glucagon or lactose
• Allergy to the patch of the CGM devices
• Patients with pheochromocytoma, insulinoma or gastroparesis
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
• Inability to understand the individual information and to give informed consent
• Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
• Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 3 patient groups

150 ug glucagon before exercise

Experimental group

Description:

150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise.

Treatment:

Drug: GlucaGen

2*75 ug glucagon before exercise and after exercise

Experimental group

Description:

75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise.

Treatment:

Drug: GlucaGen

Saline as placebo

Active Comparator group

Description:

Saline as placebo will be administered in the same amount as glucagon before and after exercise.

Treatment:

Drug: Saline