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

NCT ID: NCT05379686

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2024-05-13

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.

Conditions

Type 1 Diabetes; Hypoglycemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

150 ug glucagon before exercise

150 ug glucagon will be administered subcutaneously just before exercise

Group Type: EXPERIMENTAL

GlucaGen

Intervention Type: DRUG

150 ug glucagon will be administered to the participants before exercise.

Control

No glucagon will be administered before exercise

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

GlucaGen

150 ug glucagon will be administered to the participants before exercise.

Intervention Type: DRUG

Other Intervention Names

Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sissel B Lundemose, MD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

Steno Diabetes Center Copenhagen

Herlev, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021-004993-68

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

85256

Identifier Type: -

Identifier Source: org_study_id