Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:34 PM
Study NCT ID:
NCT07427251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Postprandial Hypo-Avoid Study
Sponsor:
Steno Diabetes Center Copenhagen
Organization:
Study Overview
Official Title:
Low-Dose Glucagon and Automated Insulin Delivery for Prevention of Spontaneous Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: