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

85256

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.

2022-09-21

2024-05-13

2024-05-13

Recruiting

16

Inclusion Criteria: * Age ≥ 18 years * Type 1 diabetes ≥ 2 years * Use of AHCL system MiniMed 780G ≥ 4 weeks * Use of Novorapid for ≥ 1 week 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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Two-arm open-label intervention study.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

2024-04-19