Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Type 1 Diabetes
Interventions
OTHER

Overnight intervention

Subjects will be admitted at the research facility at 19:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. On dual-hormone closed-loop visits, glucagon will be reconstituted according to the manufacturer's instructions and a MiniMed® Paradigm® Veo™ pump containing the glucagon solution will be installed. At 20:30, a snack containing 20g of carbohydrate will be given. Closed-loop strategy will start at 20:00 until 7:00 next morning. A glucose sensor reading will be entered manually in a tablet every 10 minutes. The tablet will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses (glucagon recommendations will only be generated during the dual hormone closed-loop visits). Pumps' parameters will then be changed manually to implement the tablet generated recommendations.

Trial Locations (1)

H2W 1R7

Institut de recherches cliniques de Montréal, Montreal

All Listed Sponsors
lead

Institut de Recherches Cliniques de Montreal

OTHER

NCT02282254 - Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia | Biotech Hunter | Biotech Hunter