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

NCT00925080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2010-02-03

No results posted yet for this 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).

Conditions

Interventions

DEVICE

IVBG

Venous blood glucose measurement every 7.5 minutes for 72-hours

Sponsors & Collaborators

  • DexCom, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-07-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00925080 on ClinicalTrials.gov