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

Summary

In this protocol the investigators plan to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol is designed to challenge the insulin management system with meals and mild exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic state. This system is designed to both

* monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
* predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.

The investigators plan to enroll 12 adult Type 1 Diabetes Mellitus (T1DM) patients (expected retention 10/12) and compare glucose control performances under two treatments: standard vs. the new insulin management system. The protocol will include a total of 6 admissions per subject (4 out-patients and 2 in-patients): screening, effort test, CGM insertion 1, inpatient 1, CGM insertion 2, and inpatient 2. During the 24h inpatient admissions, the patients will be challenged with 30 minutes of mild exercise and 3 meals, insulin coverage of these events will vary depending on the chosen treatment, each subject will be exposed to both studied treatments (repeated measure design).The order of treatment during the inpatient admissions will be randomized.

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...).

Sponsors & Collaborators

• Abbott Diabetes Care

  collaborator INDUSTRY

• Insulet Corporation

  collaborator INDUSTRY

• DexCom, Inc.

  collaborator INDUSTRY

• University of California, Santa Barbara

  collaborator OTHER

• University of Virginia

  lead OTHER

Principal Investigators

• Marc D Breton, Ph.D. · University of Virgnia - School of Medicine, Psychiatry and Neurobehavioral Sciences

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2010-12-31

Completion

2010-12-31

Countries

• United States

Study Locations