MedTrace Logo

Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System

NCT01271023 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2016-09-09

No results posted yet for this study

Summary

The purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the insulin.

The study will include two hospital stays consisting of meals and exercise scenarios. Both hospital stays will be for 24+ hours during the day and night. The study will include about 50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.

Conditions

Interventions

DEVICE

Control-to-Range Automated Insulin Management System

The devices that will be used in the Closed-Loop Control System are standardized across all study sites and include the DexCom Seven Plus Continuous Glucose Monitor (CGM), the OmniPod insulin pump, and the FreeStyle blood glucose meter. The Closed-Loop Control System will be used during all 3 admission visits.

Sponsors & Collaborators

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Roy W Beck, MD, PhD · Jaeb Center for Health Research

  • Howard Zisser, MD · Sansum Diabetes Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • France
  • Israel
  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT01271023 on ClinicalTrials.gov