MedTrace Logo

Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS)

NCT01472406 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-09-14

No results posted yet for this study

Summary

This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring System (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP device is controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a safety algorithm named the Health Monitoring System (HMS). The clinical study will include 12 to 20 adults subjects aged 21 to 65 years old.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Sansum Closed-Loop Artificial Pancreas

The Sansum Closed-loop Artificial Pancreas Device is the infrastructure that allows communication between the insulin pump, the CGM, the zone-MPC, and the HMS.

DEVICE

Insulin infusion pump

The insulin pump, which has received 510k clearance (K080639), delivers insulin subcutaneously through an infusion set.

DEVICE

Continuous Glucose Monitor

The CGM, which is an approved device (P050012), measures interstitial glucose.

DEVICE

zone-Model Predictive Control algorithm

The zone-MPC predicts future glucose values, based on CGM data, to regulate blood glucose level by increasing, decreasing, or stopping insulin infusion via an insulin infusion pump.

DEVICE

Safety Health Monitoring System

The HMS predicts future glucose values, based on CGM data, to warn the Sansum Closed-loop Artificial Pancreas Device of values below 70 mg/dL.

Sponsors & Collaborators

  • University of California, Santa Barbara

    collaborator OTHER

  • Sansum Diabetes Research Institute

    lead OTHER

Principal Investigators

  • Howard Zisser, MD · Sansum Diabetes Research Institute

  • Francis J Doyle, PhD · University of California, Santa Barbara

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01472406 on ClinicalTrials.gov