Closed-loop Control of Postprandial Glucose Levels After Meals With Different Macronutrients Content in Adults With Type 1 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

September 30, 2017

Study Completion Date

September 30, 2017

Conditions
Type 1 Diabetes
Interventions
DEVICE

Patient's insulin pump

The patient's insulin pump will be used to regulate glucose levels.

DRUG

Insulin

Patient's usual fast-acting insulin analog will be used.

DEVICE

Dexcom G4 Platinum glucose sensor

The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

OTHER

Single-hormone closed-loop

Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at IRCM at 6:30 am in a fasting state. At 7:00, single-hormone closed-loop will be initiated. At 8:00, if glucose levels are between 3.5 and 12.5 mmol/L, the meal will be served. Patients will have 20 minutes to consume the meal. If glucose levels are not in this target range, the meal will be delayed for a maximum of 45 minutes. If after 45 minutes, glucoses levels are still not between 3.5 and 12.5 mmol/L, the test will be cancelled and rescheduled. The test meals will be: 1) 75g of CHO; 2) 75g of CHO + 35g of protein; 3) 75g of CHO + 35g of fat; or 4) 75g of CHO + 35g of protein + 35g of fat. The intervention day will end at 13:00.

Trial Locations (1)

H2W 1R7

Institut de recherches cliniques de Montréal, Montreal

All Listed Sponsors
lead

Institut de Recherches Cliniques de Montreal

OTHER

NCT02774876 - Closed-loop Control of Postprandial Glucose Levels After Meals With Different Macronutrients Content in Adults With Type 1 Diabetes | Biotech Hunter | Biotech Hunter