28
Participants
Start Date
January 31, 2014
Primary Completion Date
December 31, 2015
Study Completion Date
December 31, 2015
Closed Loop
A total of 24 participants with T1 Diabetes with sensor augmented insulin pump therapy (SAPT) experience will be recruited from four tertiary hospitals and will enter an un-masked randomised-control crossover trial, with a run-in period followed by two phases (in-hospital and at-home) in each of two stages (Closed Loop and Open Loop in random order). Closed Loop will be the intervention for this study, and its performance will be assessed compared to Open Loop (control treatment).
Open Loop
"The performance of closed loop system will be compared to open loop system (Sensor Augmented Pump Therapy). Therefore, the Open Loop system will be the control treatment.~In stage 1 of study, participants are randomized to either closed loop (CL) or open loop (OL). In stage 2, all participants will be crossed to the opposite study arm.~Throughout the study, those who randomised to OL will receive exactly the same medical attention as the CL participants."
St Vincent's Hospital Melbourne, Fitzroy
Collaborators (2)
Juvenile Diabetes Research Foundation
OTHER
Medtronic
INDUSTRY
St Vincent's Hospital Melbourne
OTHER