Type 1 Diabetes Mellitus Clinical Trial
Official title:
At Home Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAs) System and Run-to-Run Adaptation
This clinical trial is a study to assess the performance of an automated glucose control system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes. Specifically, the investigators will test zone model predictive control AP that will be enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios (CR).
This clinical trial is a study to assess the performance of an automated glucose control
system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes.
Specifically, the investigators will test zone model predictive control AP that will be
enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios
(CR). This protocol builds on the investigators previously validated Zone-MPC and Health
Monitoring System (HMS) algorithms (ClinicalTrials.gov: NCT01929798) integrated into the
Diabetes Assistant (DiAs) system (ClinicalTrials.gov: NCT02463682). The same AP system used
in NCT02463682 will now be used with algorithmic adjustment of CR's prior to closed-loop
initiation, and continued BR and CR algorithmic optimization during closed-loop use for a
longer duration.
The system will be evaluated on up to 12 subjects per site (n=36 subjects) for 15 weeks at 3
different sites (William Sansum Diabetes Center, University of Virginia, and Mayo Clinic,
Rochester, MN).
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