Type 1 Diabetes Mellitus Clinical Trial
Official title:
Feasibility Study of Using a PID (Proportional-Integral-Derivative) Controller Versus an MPC (Model Predictive Control) Controller Algorithm and Health Monitoring System (HMS)
The goal of this proposed study is to explore the feasibility of using a PID
(Proportional-Integral-Derivative) controller versus an MPC (Model Predictive Control)
controller algorithm in an artificial pancreas system, all other components and study design
being equal.
The study consists of an evaluation of either type of control algorithm as a part of the
Artificial Pancreas (AP) device during two periods of 27.5-hour closed-loop control in a
clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA) separated by a
minimum of 5 days and a maximum of 2 weeks. The 27.5-hour period includes: 2 announced meals
(dinner and breakfast of 65g and 50g CHO respectively) preceded with a dose of rapid-acting
insulin equivalent to 100% bolus based on each subject's Insulin to Carbohydrate (I:C) ratio
and 1 unannounced meal (lunch of 65g carbohydrates, same meal content as dinner); complete
night from 12:00 am to 7:00 am. The goal is to demonstrate that the AP device is able to
maintain the subject blood glucose within a safe range at all times.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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