Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of the study is to compare the glucose response to low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise versus the glucose response to oral glucose intake (0.75 g/kg body weight) during exercise in individuals with AHCL-treated T1D.

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

Details

• Lead Sponsor: Steno Diabetes Center Copenhagen
• Treatments: Glucagon

Criteria

Inclusion Criteria:

• Completed at least visit 3 in the SMART-study

• Using the AHCL system MiniMed 780G

Exclusion Criteria:

• Allergies to lactose or glucagon

• Known or suspected allergies to glucagon or related products

• History of hypersensitivity or allergic reaction to glucagon or lactose

• Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis

• 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

• Lack of compliance with key study procedures at the discretion of the investigator

• 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 enrolment 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