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NCT01945060 · ClinicalTrials.gov registry record · NA
Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator
A NA study, sponsored by Marc Breton.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT01945060: Completed NA study, sponsored by Marc Breton.
NCT01945060 is a NA study that has completed, run by Marc Breton. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01945060, a NA study, has completed, sponsored by Marc Breton.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be studying to see if the heart rate informed Control To Range (hrCTR) can improve the performance of the system during and immediately after exercise.
Primary Outcome
The Low Blood Glucose Index, which quantifies the risk for hypoglycemia, and the hypoglycemic count (number sequences of blood glucose less than 70 mg/dL). The LBGI is a metric of the frequency and severity of hypoglycemia, based on an increasing weighting of progressively low glucose readings. The LBGI is measured on a scale from 0 to 100 and a higher score indicates a worse outcome.
Interventions
- DEVICE heart rate Control to Range System (hrCTR) using DiAs Platform
- OTHER DiAs Control-to-Range System not informed for heart rate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01945060 record still lists
NCT01945060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which heart rate Control to Range System (hrCTR) using DiAs Platform is the first listed.
NCT01945060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01945060 about?
NCT01945060 is a clinical study titled "Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator". The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be studying to see if the heart rate informed Control To Range (hrCTR) can ...
What is the current status of trial NCT01945060?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2013-09. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01945060?
The interventions under investigation include: heart rate Control to Range System (hrCTR) using DiAs Platform (DEVICE), DiAs Control-to-Range System not informed for heart rate (OTHER).
Who is sponsoring clinical trial NCT01945060?
This trial is sponsored by Marc Breton, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01945060's enrollment target sits among peer trials
22 1756th of 2000 higher than 239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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