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

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.

Conditions

• Diabetes Mellitus, Type 1

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 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

• 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 · University of California, Santa Barbara/William Sansum Diabetes Center

• Eyal Dassau, PhD · University of California, Santa Barbara/William Sansum Diabetes Center

• 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

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2015-10-31

Completion

2015-10-31

Countries

• United States

Study Locations