The Postprandial Hypo-Avoid Study
ConditionType 1 Diabetes Mellitus
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSteno Diabetes Center Copenhagen
About this trial
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 criteria
Qualifiers
Age ≥ 18 years
Type 1 diabetes ≥ 2 years
Using an automated insulin delivery system for ≥ 3 months
NovoRapid or Fiasp use ≥1 week
Disqualifiers
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
Trial design
Treatments tested in this trial
- Low-Dose Glucagon
- Glucose Arm
Treatment groups
18 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov