NCT02705053

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Type 1 Diabetes Mellitus

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 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: 2016-02-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-03-10
• Last updated: 2016-10-14

Locations

3 sites across 1 country: United States