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Performance Evaluation of Blood Glucose Monitoring Systems

NCT01504620 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2012-01-05

No results posted yet for this study

Summary

The goal of this single-center, comparative, open label, in-vitro diagnostic device performance evaluation was to investigate the performance of two sanofi-aventis BGMSs (BGStar® and iBGStar®) with regard to system accuracy (Polaris), precision and Hct influence (Helios).

Conditions

Interventions

OTHER

Sugar infusion

Infusion of glucose to achieve high blood glucose levels

DRUG

insulin infusion

i.v. infusion of insulin

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • IKFE Institute for Clinical Research and Development

    lead OTHER

Principal Investigators

  • Andreas Pfützner, MD, PhD · IKFE Institute for Clinical Research and Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-04-30
Completion
2011-06-30

Countries

  • Germany

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 NCT01504620 on ClinicalTrials.gov