Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions
Type 1 Diabetes
Interventions
OTHER

Dual-hormone closed-loop

Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, closed-loop will be initiated. At 9:00, a standardized breakfast (45g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions. The intervention day will end at 13:00.

DRUG

Insulin

Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).

DRUG

Glucagon

Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.

DEVICE

Dexcom G4 Platinum glucose sensor

DEVICE

Accu Chek Combo insulin pump

Trial Locations (1)

H2W 1R7

Institut de recherches cliniques de Montréal, Montreal

All Listed Sponsors
lead

Institut de Recherches Cliniques de Montreal

OTHER

NCT02798250 - Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2 | Biotech Hunter | Biotech Hunter