NCT03504046

Safety and Feasibility Evaluation of the APS APP

Inpatient Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the APS APP

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is a safety and feasibility study to assess the performance of artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the APS APP platform.

Detailed description

The system will be evaluated on up to 10 adult subjects with type 1 diabetes age 18-75 years old at a single clinical site (Sansum Diabetes Research Institute), who will complete a 48-hour closed-loop (CL) session in an observed CRC environment with medical staff present. During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session while supervised by medical staff. The AP system used consists of an insulin pump, a CGM sensor, and a phone app (the Artificial Pancreas System \[APS\] phone app).

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Artificial Pancreas App	The portable Artificial Pancreas System App (APS APP) is an artificial pancreas system comprised primarily of an insulin pump, a continuous glucose monitor (CGM), and a cellular phone device to connect the components.

Timeline

• Start date: 2018-02-28
• Primary completion: 2018-09-04
• Completion: 2018-09-04
• First posted: 2018-04-20
• Last updated: 2018-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study