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

NCT05379686 | Completed Results

• 2 other identifiers: 852562021-004993-68
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

Type 1 Diabetes; Hypoglycemia; Exercise; Glucagon; Hybrid closed-loop system

Outcome Measures

Primary Outcomes (1)

• 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

  This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.

  0 min to +105 min

Secondary Outcomes (12)

• 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 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

Study Arms (2)

150 ug glucagon before exercise

EXPERIMENTAL

150 ug glucagon will be administered subcutaneously just before exercise

Drug: GlucaGen

Control

NO INTERVENTION

No glucagon will be administered before exercise

Interventions

GlucaGen DRUG

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

Also known as: Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01

150 ug glucagon before exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Interventions

Glucagon-Like Peptide 1; Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr
• Organization: Steno Diabetes Center Copenhagen

SDC-FP-Stenoinfo@regionh.dk

+45 39 68 08 00

Study Officials

• Sissel B Lundemose, MD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm open-label intervention study.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: September 21, 2022
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: August 29, 2025
• Results First Posted: August 29, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)