Clinical Trials Directory

Trials / Completed

CompletedNCT01730885

A Trial Investigating the Accuracy and Precision of the BGStar® and iBGStar® Blood Glucose Meter in Subjects With Type 1 Diabetes

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Profil Institut für Stoffwechselforschung GmbH · Industry
Sex
All
Age
18 Years – 74 Years
Healthy volunteers
Not accepted

Summary

Due to continuing technological progress and better understanding of the needs for glucose monitoring, the performance requirements of blood glucose meters, primarily regarding their accuracy, are constantly debated and keep evolving as a consequence. Recently a discussion was initiated by the Food and Drug Administration (FDA) to improve the accuracy of BG meters in the point-of-care testing setting by asking for fulfilment of higher requirements.

Conditions

Interventions

TypeNameDescription
OTHERComparison of different Blood Glucose Meters

Timeline

Start date
2012-11-01
Primary completion
2014-01-01
First posted
2012-11-21
Last updated
2014-02-05

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01730885. Inclusion in this directory is not an endorsement.