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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
10
Sansum Diabetes Research Institute
Santa Barbara, California, United States
time spent in safe blood glucose range
The percentage of time spent in safe blood glucose range of \[80-140\] mg/dl will be the primary endpoint. More time spent inside the desired range will be considered successful. Expected levels are \[70-180\] mg/dl in the 5 hours after meals.
Time frame: 24-hour closed loop
glucose level extremes and need for outside intervention
The secondary endpoint measures glucose extremes and the need for outside intervention to prevent hypoglycemia or hyperglycemia. Interventions would be insulin injections or oral carbohydrates given to the subject by the physician. No need for physician intervention will be considered a successful outcome.
Time frame: 24-hour closed loop
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