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NCT00925080 · ClinicalTrials.gov registry record

Pivotal Study of the Intravenous Blood Glucose (IVBG) System, In-Clinic Setting

A clinical trial, sponsored by DexCom.

Completed
Registry status
50
Enrollment target

NCT00925080: Completed study, sponsored by DexCom.

NCT00925080 is a clinical trial that has completed, run by DexCom. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00925080 has completed, sponsored by DexCom.

COMPLETED
Registry status
50 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate safety and accuracy of the IVBG System (the "System") when used to track blood glucose in insulin treated subjects with diabetes mellitus in an in-clinic setting for up to 72 hours (per subject). Reference blood glucose measurements will be collected across the entire reportable range of the System (e.g., 40 400 mg/dL) with adequate sampling at the upper and lower ends of this range. IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels \< 75 mg/dL, and within ±20% at YSI glucose levels \>75 mg/dL).

Interventions

  • DEVICE IVBG

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2009-06
Est. Completion 2009-08
DexCom

26 total trials

What the finished NCT00925080 record still lists

NCT00925080 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which IVBG is the first listed.

NCT00925080 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00925080 about?

NCT00925080 is a clinical study titled "Pivotal Study of the Intravenous Blood Glucose (IVBG) System, In-Clinic Setting". The purpose of this study is to evaluate safety and accuracy of the IVBG System (the "System") when used to track blood glucose in insulin treated subjects with diabetes mellitus in an in-clinic setting for up to 72 hours (per subject). Reference blood glucose measurements will be collected across t...

What is the current status of trial NCT00925080?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2009-06. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00925080?

The interventions under investigation include: IVBG (DEVICE).

Who is sponsoring clinical trial NCT00925080?

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

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Source: ClinicalTrials.gov NCT00925080, the US trial registry maintained by the National Library of Medicine. NCT00925080 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.