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NCT01514292 · ClinicalTrials.gov registry record · NA

Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System

A NA study, sponsored by DexCom.

Completed
Registry status
NA
Development phase
72
Enrollment target

NCT01514292: Completed NA study, sponsored by DexCom.

NCT01514292 is a NA study that has completed, run by DexCom. The registered enrollment target is 72 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01514292, a NA study, has completed, sponsored by DexCom.

COMPLETED
Registry status
NA
Development phase
72 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people \>18 years-old with diabetes mellitus. The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI. Safety of the G4 System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.

Primary Outcome

The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements.

Interventions

  • DEVICE Continuous Glucose Monitoring of glucose levels (Dexcom)

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2011-12
Est. Completion 2012-02
Phase NA
DexCom

26 total trials

What the finished NCT01514292 record still lists

NCT01514292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Continuous Glucose Monitoring of glucose levels (Dexcom) is the first listed.

NCT01514292 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01514292 about?

NCT01514292 is a clinical study titled "Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System". The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people \>18 years-old with diabetes mellitus. The primary objective is to characterize the System performance with respect to labora...

What is the current status of trial NCT01514292?

This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2011-12. Estimated completion is 2012-02.

What interventions are being tested in trial NCT01514292?

The interventions under investigation include: Continuous Glucose Monitoring of glucose levels (Dexcom) (DEVICE).

Who is sponsoring clinical trial NCT01514292?

This trial is sponsored by DexCom, which has 26 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01514292's enrollment target sits among peer trials

72 1089th of 2000 higher than 899 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 NCT01514292, the US trial registry maintained by the National Library of Medicine. NCT01514292 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.