Clinical trial NCT05379686: Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
Official title: Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Hypoglycemia
Keywords: Type 1 Diabetes
Hypoglycemia
Exercise
Glucagon
Hybrid closed-loop system
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two-arm open-label intervention study.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: 0 min to +105 min
Secondary outcomes:
measure: Difference in incidence rate of hypoglycaemic events (PG<3.9 mmol/l) between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in time (min) to hypoglycaemia (PG<3.9 mmol/l) between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in percentage of time below target glucose range (PG<3.9 mmol/l) between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in percentage of time above target glucose range (PG>10.0 mmol/l) between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in incidence rate of hyperglycaemia (PG>10.0 mmol/l) between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in nadir PG concentration between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in peak PG concentration between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in incremental peak PG concentration between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in mean PG concentration between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in PG Area Under the Curve (AUC) between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in standard deviation in PG concentrations between visit B and C
timeFrame: 0 min to +105 min
measure: Difference in Coefficient of variation in PG concentrations between visit B and C
timeFrame: 0 min to +105 min
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Sissel B Lundemose, MD
role: PRINCIPAL_INVESTIGATOR
References: