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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: Completed NA study of Type 1 Diabetes, sponsored by University of Virginia.
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 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Hypoglycemic events were defined as below 3.9 mmol/liter and the percentage of time within the range of 3.9 to 7.8 mmol/liter overnight (21:30 until 08:00) as measured by reference blood glucose (YSI or Beckman Glucose Analyzer).
Conditions Studied
Interventions
- DEVICE Closed-Loop, Model Predictive Control (MPC)
- DEVICE Open-Loop
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-05 |
| Est. Completion | 2009-02 |
| Phase | NA |
What the finished NCT00977808 record still lists
NCT00977808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00977808's enrollment target sits among peer trials
12 176th of 198 higher than 19 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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