Analytical Performance Evaluation of Blood Glucose Monitoring Systems- Investigator Sponsored Contour® XT Comparator Study - Ulm Germany
Not Applicable
Completed
- Conditions
- Diabetes
- Registration Number
- NCT01789021
- Lead Sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Brief Summary
In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- 18 years of age or older
- Male or female subjects with type 1 or type 2 diabetes or healthy subjects
- For BG adjustment people with type 1 diabetes
Exclusion Criteria
- Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient
- Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient
- Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study
- For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness
- Legal incompetence or limited legal competence
- Age < 18 years
- Dependency from the sponsor or the clinical investigator
- Mental incapacity or language barriers precluding adequate compliance with the study procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value For each subject, the experimental phase has an expected duration of up to 6 hours
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the key analytical performance metrics used to evaluate the accuracy of the Bayer Contour XT blood glucose monitoring system in NCT01789021?
How does the Bayer Contour XT compare to other commercial blood glucose monitoring systems in detecting hypoglycemic episodes in diabetic patients?
What are the potential limitations of current blood glucose monitoring systems in capturing interstitial glucose fluctuations in type 1 and type 2 diabetes?
Are there specific biomarkers or patient subgroups that influence the accuracy of blood glucose monitoring systems like the Bayer Contour XT?
What are the implications of the NCT01789021 trial results for the development of next-generation continuous glucose monitoring technologies in diabetes management?
Trial Locations
- Locations (1)
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
🇩🇪Ulm, Germany
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm🇩🇪Ulm, Germany