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NCT01582139 · ClinicalTrials.gov registry record · NA

Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker

A NA study, sponsored by University of Virginia.

Completed
Registry status
NA
Development phase
12
Enrollment target

NCT01582139: Completed NA study, sponsored by University of Virginia.

NCT01582139 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01582139, a NA study, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
NA
Development phase
12 participants
Enrollment target

Study Summary

The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell Phone + Closed Loop Control) 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 information about heart rate can help the AP Platform reduce hypoglycemia related to exercise.

Primary Outcome

Plasma glucose based number of hypoglycemic events, defined as consecutive plasma readings below 70mg/dl to measure the capacity of the system to protect patients against the risk of hypoglycemia. Two events separated by only one Yellow Springs Instrument (YSI) value over 70 are considered to form a single event.

Interventions

  • DEVICE Heart rate informed SSM+HMM

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2012-05
Est. Completion 2012-08
Phase NA
University of Virginia

449 total trials

What the finished NCT01582139 record still lists

NCT01582139 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Heart rate informed SSM+HMM is the first listed.

NCT01582139 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01582139 about?

NCT01582139 is a clinical study titled "Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker". The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell Phone + Closed Loop Control) 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 informati...

What is the current status of trial NCT01582139?

This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2012-05. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01582139?

The interventions under investigation include: Heart rate informed SSM+HMM (DEVICE).

Who is sponsoring clinical trial NCT01582139?

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

How this trial's enrollment target compares

Where NCT01582139's enrollment target sits among peer trials

12 1913th of 2000 higher than 74 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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Source: ClinicalTrials.gov NCT01582139, the US trial registry maintained by the National Library of Medicine. NCT01582139 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.