Controlled Insulin Delivery: Combining Technology With Treatment

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2010

Conditions
Diabetes Mellitus, Type 1
Interventions
DEVICE

Closed-loop session

"Subjects will arrive fasting at 7am unless needed for hypoglycemia (glucose \< 70 mg/dL) and no extra bolus insulin after 3am. An IV catheter will be inserted for blood samples and for IV administration of glucose if necessary. Blood samples will be analyzed for glucose by YSI 2300Stat every 30 minutes.~Breakfast consisting of 25g of CHO will be eaten at 7:30 am and the subject will bolus for this amount of CHO. The controller is switched on on the down slope of the meal response, and the subject is brought to a basal steady-state by the controller. Target blood glucose is 110 ± 30-mg/dL.~After approximately 3 hours a small lunch will be eaten consisting of 25g of CHO (unannounced meal challenge). The subject will be monitored until blood glucose returns to euglycemia."

Trial Locations (2)

93105

Sansum Diabetes Research Institute, Santa Barbara

Unknown

Schneider Children's Medical Center of Israel, Petah Tikva

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

Schneider Children's Medical Center, Israel

OTHER

lead

Sansum Diabetes Research Institute

OTHER