Feasibility Study of a Modular Control to Range System in Type 1 Diabetes Mellitus

NACompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Type 1 Diabetes Mellitus
Interventions
DEVICE

Closed Loop Control (CLC)

In this study, the researchers compared the management of diabetes during physical activity and meals with the closed-loop system developed at the University of Virginia. This Control to Range System uses two DexCom Seven Continuous Glucose Monitor, a computer containing an investigational control algorithm (well-defined instructions that are expressed in mathematical equations), and an OmniPod Insulin Management System, a portable subcutaneous (under the skin) insulin pump. During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms.

DEVICE

Open Loop

This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).

Trial Locations (1)

22904

University of Virginia Health System, Charlottesville

All Listed Sponsors
collaborator

Abbott Diabetes Care

INDUSTRY

collaborator

Insulet Corporation

INDUSTRY

collaborator

DexCom, Inc.

INDUSTRY

collaborator

University of California, Santa Barbara

OTHER

lead

University of Virginia

OTHER

NCT01418703 - Feasibility Study of a Modular Control to Range System in Type 1 Diabetes Mellitus | Biotech Hunter | Biotech Hunter