Dual-hormone Artificial Pancreas Versus Single-hormone Under Exercise and a Meal Challenge

NARecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

April 17, 2024

Primary Completion Date

August 17, 2024

Study Completion Date

August 17, 2024

Conditions
Type 1 Diabetes
Interventions
DEVICE

Automated insulin delivery system algorithm with a dual-hormone configuration (insulin and glucagon) for glucose control

Participants will wear a CSII system with the CGM device. Insulin will be administered through the AID dHmG system, and microdoses of glucagon (GlucaGen®) will be subcutaneously administered based on automatic recommendations for hypoglycemia mitigation. The subcutaneous administration of reconstituted glucagon will be conducted using a 0.5 mL insulin syringe with needle, allowing for precise doses as small as 0.01mg/0.01 mL.

DEVICE

Automated insulin delivery system with a single-hormone configuration (insulin) with rescue carbohydrate recommendations for glucose control

Participants will wear a CSII system with the CGM device. Insulin will be administered through the AID sHC system, along with automatic rescue carbohydrate recommendations for hypoglycemia mitigation. As per the carbohydrate recommendation, participants will received the suggested amount of carbohydrates using an oral glucose gel containing 15g of carbohydrates per unit.

Trial Locations (1)

46010

RECRUITING

Hospital Clínico Universitario de Valencia, Valencia

All Listed Sponsors
collaborator

Hospital Clínico Universitario de Valencia

OTHER

lead

Universitat Politècnica de València

OTHER