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NCT00977808 · ClinicalTrials.gov registry record · NA

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

A NA study of Type 1 Diabetes, sponsored by University of Virginia.

Completed
Registry status
NA
Development phase
12
Enrollment target
1
Study location

NCT00977808 is a NA study of Type 1 Diabetes that has completed, run by University of Virginia. The registered enrollment target is 12 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00977808, a NA study of Type 1 Diabetes, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
NA
Development phase
12 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DEVICE Closed-Loop, Model Predictive Control (MPC)
  • DEVICE Open-Loop

Study Locations (1)

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2008-05
Est. Completion 2009-02
Phase NA

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT00977808

The ClinicalTrials.gov registry entry for NCT00977808 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Closed-Loop, Model Predictive Control (MPC) is the first listed.

NCT00977808 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT00977808 about?

NCT00977808 is a clinical study titled "Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)". 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 ...

What is the current status of trial NCT00977808?

This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2008-05. Estimated completion is 2009-02.

What conditions does trial NCT00977808 study?

This clinical trial studies the following conditions: Type 1 Diabetes.

What interventions are being tested in trial NCT00977808?

The interventions under investigation include: Closed-Loop, Model Predictive Control (MPC) (DEVICE), Open-Loop (DEVICE).

Who is sponsoring clinical trial NCT00977808?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00977808 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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