NCT02438670

MPC Versus PID for Closed Loop Insulin Delivery

Use of a PID (Proportional-Integral-Derivative) Controller Versus an MPC (Model Predictive Control) Controller Algorithm and Health Monitoring System (HMS) for Closed-Loop Insulin Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this proposed study is to compare use of 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 design, power calculation and endpoints were developed based on the results of an initial feasibility study (ClinicalTrials.gov Identifier: NCT01987206) that has already been completed.

Detailed description

This randomized crossover study consists of an evaluation of either type of control algorithm (MPC or PID) as a part of the Artificial Pancreas (AP) device during two periods of 27.5-hour closed-loop control in a minimally supervised setting (outpatient research area at the William Sansum Diabetes Center, 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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	PID control algorithm
DEVICE	MPC control algorithm

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-05-08
• Last updated: 2016-07-22

Locations

1 site across 1 country: United States