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Low-Dose Glucagon and Automated Insulin Delivery for Prevention of Spontaneous Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The objective of the study is to evaluate whether pre-exercise administration of low-dose subcutaneous glucagon prevents or attenuates exercise-induced declines in plasma glucose concentration during and after moderate-intensity continuous exercise (MICE) performed approximately 90 minutes after a meal in adults with type 1 diabetes using an automated insulin delivery (AID) system. The primary endpoint is the difference in the change in plasma glucose (PG) from exercise initiation to the nadir during exercise and through the 2-hour post-exercise period between the glucagon (GCN) and carbohydrate (CHO) visits.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Type 1 diabetes ≥ 2 years

• Using an automated insulin delivery system for ≥ 3 months

• NovoRapid or Fiasp use ≥1 week

• Proficiency in carbohydrate counting

Locations
Other Locations
Denmark
Steno Diabetes Center Copenhagen
RECRUITING
Herlev
Contact Information
Primary
Emilie Lindkvist, MD, PhD Candidate
emilie.lindkvist@regionh.dk
+45 21563054
Backup
Sissel Lundemose, MD, PhD
sissel.lundemose@regionh.dk
+4523742764
Time Frame
Start Date: 2026-04-27
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 18
Treatments
Active_comparator: Visit GCN
Plasma and sensor glucose are monitored before, during, and after a bout of moderate-intensity exercise shortly after consumption of a meal. Before exercise initiation, participants will be given low-dose glucagon to prevent hypoglycemia.
Active_comparator: Visit CHO
Plasma and sensor glucose are monitored before, during, and after a bout of moderate-intensity exercise shortly after consumption of a meal. Before exercise initiation, participants will be given a dose of glucose to prevent hypoglycemia.
Related Therapeutic Areas
Sponsors
Leads: Steno Diabetes Center Copenhagen

This content was sourced from clinicaltrials.gov