Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
- Registration Number
- NCT05379686
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 150 ug glucagon before exercise GlucaGen 150 ug glucagon will be administered subcutaneously just before exercise
- Primary Outcome Measures
Name Time Method Difference in percentage of time in target glucose range (PG: 3.9 - 10.0 mmol/l) during and for 1-hour after dynamic physical exercise between visit B and C 0 min to +105 min
- Secondary Outcome Measures
Name Time Method Difference in incidence rate of hypoglycaemic events (PG<3.9 mmol/l) between visit B and C 0 min to +105 min Difference in time (min) to hypoglycaemia (PG<3.9 mmol/l) between visit B and C 0 min to +105 min Difference in percentage of time below target glucose range (PG<3.9 mmol/l) between visit B and C 0 min to +105 min Difference in nadir PG concentration between visit B and C 0 min to +105 min Difference in mean PG concentration between visit B and C 0 min to +105 min Difference in percentage of time above target glucose range (PG>10.0 mmol/l) between visit B and C 0 min to +105 min Difference in incidence rate of hyperglycaemia (PG>10.0 mmol/l) between visit B and C 0 min to +105 min Difference in peak PG concentration between visit B and C 0 min to +105 min Difference in incremental peak PG concentration between visit B and C 0 min to +105 min Difference in standard deviation in PG concentrations between visit B and C 0 min to +105 min Difference in PG Area Under the Curve (AUC) between visit B and C 0 min to +105 min Difference in Coefficient of variation in PG concentrations between visit B and C 0 min to +105 min
Trial Locations
- Locations (1)
Steno Diabetes Center Copenhagen
🇩🇰Herlev, Denmark