Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

September 30, 2018

Study Completion Date

September 30, 2018

Conditions
Type 2 Diabetes
Interventions
OTHER

24-hour intervention with multiple daily injections

Subjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. The subjects will carry on with their normal insulin therapy. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.

OTHER

24-hour intervention with closed-loop strategy

Subjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing subject's usual fast acting insulin analog will be placed in the insulin pump. Closed-loop strategy will start at 21:00 until 21:00 the next day. Neither basal nor prandial insulin injections will be given. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.

DRUG

Insulin

Subject's usual insulin analog will be used.

DEVICE

Insulin pump Accu-Chek Combo

During closed-loop intervention, the Accu-Chek Combo (Roche) insulin pump will be used

DEVICE

Dexcom G4 Platinum

In both visits, glucose levels will be measure with the Dexcom G4 Platinum (Dexcom)

Trial Locations (2)

H2W 1R7

Institut de recherches cliniques de Montréal, Montreal

J1H 5N4

Centre hospitalier universitaire de Sherbrooke, Sherbrooke

All Listed Sponsors
collaborator

Réseau de recherche en santé cardiométabolique, diabète et obésité

UNKNOWN

lead

Institut de Recherches Cliniques de Montreal

OTHER

NCT02490085 - Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy | Biotech Hunter | Biotech Hunter