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Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)

NCT00977808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-09-04

Study results available
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Summary

This study plans to link two existing technologies, the insulin pump and the continuous glucose monitor (CGM), to essentially develop an artificial pancreas, i.e., closed-loop. This will be done using two continuous glucose monitors (CGMs), a computer containing an investigational control algorithm that uses glucose information from the CGM to recommend insulin dosing, and an insulin pump. The purpose of this study is to test the ability of continuous glucose monitors together with an insulin pump and a mathematical formula to control blood sugar levels of people with type 1 diabetes.

The Closed-Loop control algorithm will:

1. Suggest adequate insulin delivery for blood glucose control in steady state (overnight);
2. Cover adequately with an insulin bolus the pre-set carbohydrate content of a breakfast.

If successful, this study will conceptually prove the feasibility of automated model-predictive closed-loop glucose control in T1DM.

Conditions

Interventions

DEVICE

Closed-Loop, Model Predictive Control (MPC)

Subjects used the OmniPod Insulin Management System (Insulet Corp.) and Insulin lispro (Eli Lilly, Indianapolis, IN). MPC algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician. Otherwise, the admission remained the same as in the open-loop admission (i.e. meals, sleep, etc...).

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 used their own insulin pumps and Insulin lispro (Eli Lilly, Indianapolis, IN). Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, sleep, etc...).

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Boris P Kovatchev, Ph.D. · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

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 NCT00977808 on ClinicalTrials.gov