NCT07427251

The Postprandial Hypo-Avoid Study

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, non-blinded, two-period crossover study including 18 adults with type 1 diabetes using an EU-approved automated insulin delivery (AID) system. Each participant will attend one screening visit followed by two experimental visits performed in random order, separated by at least seven days. Eligible participants are adults (≥18 years) with type 1 diabetes for at least 2 years, using an automated insulin delivery system for ≥3 months, treated with NovoRapid or Fiasp for at least 1 week prior to enrollment, and proficient in carbohydrate counting. At each experimental visit, participants will perform a standardized bout of MICE approximately 90 minutes after a meal. On one visit, a low-dose glucagon injection will be administered immediately before exercise; on the other, 20 g oral glucose tablets will be consumed. Right before exercise, the AID system's higher glucose target/exercise mode will be activated and will remain active until 15 minutes after exercise.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Low-Dose Glucagon	Participants will be given a low-dose of glucagon before starting the exercise session
DIETARY_SUPPLEMENT	Glucose Arm	Participants will be given a dose of glucose before starting exercise

Timeline

• Start date: 2026-03-15
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2026-02-23
• Last updated: 2026-02-27