Glucagon and Advanced HCL System to Prevent Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes (HYPOAVOID)

Steno Diabetes Centers

Status

Completed

Conditions

Hypoglycemia

Type 1 Diabetes

Treatments

Drug: GlucaGen

Study type

Interventional

Funder types

Other

Identifiers

NCT05379686

2021-004993-68 (EudraCT Number)

85256

Details and patient eligibility

About

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.

Full 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. administration of 150 ug glucagon prior to a 45-min moderate intensity continuous exercise session and subsequently continue into a 1-hour post-exercise observation period. During study visit C the exact same procedures will be followed with the omission of glucagon.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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