Status:
COMPLETED
Performance Evaluation of Blood Glucose Monitoring Systems
Lead Sponsor:
IKFE Institute for Clinical Research and Development
Collaborating Sponsors:
Sanofi-Synthelabo
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 re...
Detailed Description
The main study (Polaris) investigated blood glucose measuring accuracy and intra-assay precision while the substudy (Helios) investigated potential haematocrit interference of sanofi-aventis BGMSs BGS...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01504620
Start Date
January 1 2011
End Date
June 1 2011
Last Update
January 5 2012
Active Locations (1)
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1
IKFE - Institute for Clinical Research and Development
Mainz, Germany, 55116