System Accuracy of 12 Bloog Glucose Monitoring Systems
Not Applicable
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT05219526
- Lead Sponsor
- Institut fur Diabetes Karlsburg GmbH
- Brief Summary
The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
- Male or female, with clinical indication for blood glucose measurement
- Signed informed consent form
- Minimum age of 18 years
- Subjects are legally competent and capable to understand character, meaning and consequences of the study.
Exclusion Criteria
- Pregnancy or lactation period
- Severe acute disease (at the study physician's discretion)
- Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
- Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
- Being unable to give informed consent
- < 18 years
- Legally incompetent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Measurement performance: System accuracy 4-6 hours Assessment of the analytical measurement performance of blood glucose monitoring systems based on procedures defined in DIN EN ISO 15197 using results obtained from fingertip blood glucose measurements compared to a reference equipment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut für Diabetes Karlsburg GmbH
🇩🇪Karlsburg, Mecklenburg Vorpommern, Germany