Performance Evaluation of Blood Glucose Monitoring Systems

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: IKFE Institute for Clinical Research and Development
• Collaborator: Sanofi-Synthelabo
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• healthy subjects or patients with type 1 or type 2 diabetes

• screening glucose levels fall into required glucose ranges

• screening hematocrit values between 36 % to 55 %

Exclusion Criteria:

• history of hypotension during blood draws

• intake of drugs known to interfere with blood glucose readings

• biochemical safety parameters outside of reference ranges

• Hb < 11 g/dL

• lack of compliance

• history of frequent hypoglycemia