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

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).

Conditions

• Type 1 Diabetes Mellitus

Interventions

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)

Sponsors & Collaborators

• Harvard University

  collaborator OTHER

• University of California, Santa Barbara

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• University of Padova

  collaborator OTHER

• Sansum Diabetes Research Institute

  lead OTHER

Principal Investigators

• Francis J Doyle III, PhD · Harvard University

• Eyal Dassau, PhD · Harvard University

• Jordan E Pinsker, MD · Sansum Diabetes Research Institute

• Ananda Basu, MD · Mayo Clinic, Rochester, MN

• Yogish Kudva, MD · Mayo Clinic, Rochester, MN

• Boris Kovatchev, PhD · University of Virginia

• Sue Brown, MD · University of Virginia

• Stephen Patek, PhD · University of Virginia

• Claudio Cobelli, PhD · University of Padova

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• United States

Study Locations