Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Type 1 Diabetes
Interventions
DEVICE

Closed-Loop Control System

"This investigational device system included the following components:~* DiAs - a smart-phone medical platform;~* Dexcom G4 Platinum CGM system connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~* Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~* Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network~* Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"

DEVICE

Sensor-Augmented Pump (SAP)

"This commercial device system included the following components:~* Dexcom G4 Platinum CGM system;~* Roche Accu-Chek insulin pump"

Trial Locations (6)

22908

University of Virginia, Charlottesville

34295

Montpellier University Hospital, Montpellier

49202

National Center for Childhood Diabetes- Schneider Children's Medical Center, Petah Tikva

93105

Sansum Diabetes Research Institute, Santa Barbara

93106

University of Padova, Padua

94305

Stanford University, Stanford

All Listed Sponsors
lead

Jaeb Center for Health Research

OTHER