Status:
COMPLETED
Glucagon and Advanced HCL System to Prevent Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Type 1 Diabetes
Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary aim of the study is to evaluate the glucose response to low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise in individuals with AHCL-treated T1D.
Detailed Description
The study consists of a screening visit (visit A) and two additional study visits (visit B and visit C) completed in a sequential order. During study visit B participants will receive s.c. administrat...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Type 1 diabetes ≥ 2 years
- Use of AHCL system MiniMed 780G ≥ 4 weeks
- Use of Novorapid for ≥ 1 week
Exclusion
- 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
Key Trial Info
Start Date :
September 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05379686
Start Date
September 21 2022
End Date
May 13 2024
Last Update
August 29 2025
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730