NCT02463682

Early Feasibility Study of Zone-MPC and HMS With DiAs in the Outpatient Setting

Early Feasibility Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAS) in the Outpatient Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a feasibility study of an artificial pancreas (AP) system with our previously validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov: NCT01929798) integrated into the Diabetes Assistant (DiAs) system.

Detailed description

This is a feasibility study of an artificial pancreas (AP) system with our previously validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov: NCT01929798) integrated into the Diabetes Assistant (DiAs) system. The system will be evaluated on 2-3 subjects per site (n=6-9 subjects) for 2 weeks at 3 different sites (William Sansum Diabetes Center, University of Virginia, and Mayo Clinic, Rochester, MN). Basal rates will be adjusted in a run-to-run manner by study physicians prior to the closed-loop phase for a maximum of 3 weeks. Subjects will then complete 2 weeks at home use of the Zone-MPC/HMS system using the DIAs platform for a closed-loop feasibility trial. The purpose of this pilot study is to establish that safe day-and-night use of the Zone-MPC/HMS system integrated into the DiAs is achievable in the home environment, to analyze and learn to improve upon the run-to- run optimization process, and to collect efficacy data to inform a future larger study.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	CGM and Insulin Pump	Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump
DEVICE	Closed-Loop Control System	The devices that will be used in the Closed-Loop Control System include the following components: DiAs - a smart-phone medical platform; Dexcom Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-06-04
• Last updated: 2016-04-11

Locations

3 sites across 1 country: United States