12
Participants
Start Date
November 30, 2011
Primary Completion Date
March 31, 2014
Study Completion Date
March 31, 2014
Sansum Closed-Loop Artificial Pancreas
The Sansum Closed-loop Artificial Pancreas Device is the infrastructure that allows communication between the insulin pump, the CGM, the zone-MPC, and the HMS.
Insulin infusion pump
The insulin pump, which has received 510k clearance (K080639), delivers insulin subcutaneously through an infusion set.
Continuous Glucose Monitor
The CGM, which is an approved device (P050012), measures interstitial glucose.
zone-Model Predictive Control algorithm
The zone-MPC predicts future glucose values, based on CGM data, to regulate blood glucose level by increasing, decreasing, or stopping insulin infusion via an insulin infusion pump.
Safety Health Monitoring System
The HMS predicts future glucose values, based on CGM data, to warn the Sansum Closed-loop Artificial Pancreas Device of values below 70 mg/dL.
Sansum Diabetes Research Institute, Santa Barbara
University of California, Santa Barbara
OTHER
Sansum Diabetes Research Institute
OTHER