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NCT00884611 · ClinicalTrials.gov registry record · NA

Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study

A NA study, sponsored by Stanford University.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT00884611: Completed NA study, sponsored by Stanford University.

NCT00884611 is a NA study that has completed, run by Stanford University. The registered enrollment target is 20 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.

View on ClinicalTrials.gov ↗

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The verdict

NCT00884611, a NA study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation. The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.

Primary Outcome

Nights with CGM sensor values \< 60 mg/dL were considered to be undesirable. A Kalman filter-based model algorithm predicted whether the sensor glucose level would fall below 80 mg/dL and would suspend insulin delivery as needed. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.

Interventions

  • DEVICE Predictive Low Glucose Suspend Algorithm ON
  • DEVICE Predictive Low Glucose Suspend Algorithm OFF

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2007-05
Est. Completion 2011-08
Phase NA
Stanford University

1,744 total trials

What the finished NCT00884611 record still lists

NCT00884611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 2 interventions - of which Predictive Low Glucose Suspend Algorithm ON is the first listed.

NCT00884611 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00884611 about?

NCT00884611 is a clinical study titled "Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study". This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation. The purpose of doing this research study is ...

What is the current status of trial NCT00884611?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2007-05. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00884611?

The interventions under investigation include: Predictive Low Glucose Suspend Algorithm ON (DEVICE), Predictive Low Glucose Suspend Algorithm OFF (DEVICE).

Who is sponsoring clinical trial NCT00884611?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00884611's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 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 NCT00884611, the US trial registry maintained by the National Library of Medicine. NCT00884611 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.