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Safety and Feasibility Evaluation of the APS APP

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03504046
Study type Interventional
Source Sansum Diabetes Research Institute
Contact
Status Completed
Phase Phase 2/Phase 3
Start date February 28, 2018
Completion date September 4, 2018
View Details
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