N/A
N=10
Glucagon and Advanced HCL System to Prevent Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
Type 1 Diabetes · Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT05379686 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: 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 — 100; 100 Percentage of time in range
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GlucaGen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Steno Diabetes Center Copenhagen
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
100; 100 | — |
| SECONDARY Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C |
0; 0 | — |
| SECONDARY Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C |
NA; NA | — |
| SECONDARY Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C |
0; 0 | — |
| SECONDARY Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C |
0; 0 | — |
| SECONDARY Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C |
0; 0 | — |
| SECONDARY Difference in Nadir PG Concentration Between Visit B and C |
5.8; 5.8 | — |
| SECONDARY Difference in Peak PG Concentration Between Visit B and C |
9.3; 7.5 | — |
| SECONDARY Difference in Incremental Peak PG Concentration Between Visit B and C |
1.8; -0.6 | — |
| SECONDARY Difference in Mean PG Concentration Between Visit B and C |
8.3; 6.7 | — |
| SECONDARY Difference in PG Area Under the Curve (AUC) Between Visit B and C |
824.2; 686.2 | — |
| SECONDARY Difference in Standard Deviation in PG Concentrations Between Visit B and C |
1.0; 0.5 | — |
| SECONDARY Difference in Coefficient of Variation in PG Concentrations Between Visit B and C |
12.3; 7.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05379686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.