NCT05219526CompletedNot Applicable
Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015
Institut fur Diabetes Karlsburg GmbH2 sites in 1 country700 target enrollmentStarted: January 3, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 700
- Locations
- 2
- Primary Endpoint
- Measurement performance: System accuracy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Measurement performance: System accuracy
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Matthes Kenning
Director, PhD
Institut fur Diabetes Karlsburg GmbH
Study Sites (2)
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