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

Steno Diabetes Center Copenhagen10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Hypoglycemia

Interventions

GlucaGenDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Steno Diabetes Center Copenhagen

Herlev, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 0 min to +105 min

Secondary Outcomes

Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C

This outcome measure assesses the frequency of hypoglycemic events experienced by participants over a specified monitoring period.

Time frame: 0 min to +105 min

Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C

This outcome measure evaluates the time (in minutes) taken to reach hypoglycemia during a specified monitoring period or following a specific intervention.

Time frame: 0 min to +105 min

Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C

Time frame: 0 min to +105 min

Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C

Data from ClinicalTrials.gov

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