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NCT01736930 · ClinicalTrials.gov registry record · Phase 2

An Outpatient Pump Shutoff Pilot Feasibility and Safety Study

A Phase 2 study of Type 1 Diabetes, sponsored by Jaeb Center for Health Research.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
2
Study locations

NCT01736930 is a Phase 2 study of Type 1 Diabetes that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 20 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01736930, a Phase 2 study of Type 1 Diabetes, has completed, sponsored by Jaeb Center for Health Research.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off. This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours. The study will include 2 clinical centers in the United States.

Conditions Studied

Interventions

  • DEVICE Pump suspension

Study Locations (2)

California

  • Stanford University - Stanford

Colorado

  • Barbara Davis Center for Childhood Diabetes - Aurora

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2012-01
Est. Completion 2012-06
Phase Phase 2

Sponsor

Jaeb Center for Health Research

119 total trials

What the Registry Record Tells You About NCT01736930

The ClinicalTrials.gov registry entry for NCT01736930 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 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 (98% lower). The listed sponsor is Jaeb Center for Health Research, which has 119 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 1 intervention - of which Pump suspension is the first listed.

NCT01736930 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Colorado.

Frequently Asked Questions

What is clinical trial NCT01736930 about?

NCT01736930 is a clinical study titled "An Outpatient Pump Shutoff Pilot Feasibility and Safety Study". The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular ...

What is the current status of trial NCT01736930?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2012-01. Estimated completion is 2012-06.

What conditions does trial NCT01736930 study?

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

What interventions are being tested in trial NCT01736930?

The interventions under investigation include: Pump suspension (DEVICE).

Who is sponsoring clinical trial NCT01736930?

This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01736930 being conducted?

This trial has 2 study locations across California, Colorado. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.