Blood Glucose Monitoring Systems: Discounter Versus Brand
Not Applicable
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT05031000
- Lead Sponsor
- Institut fur Diabetes Karlsburg GmbH
- Brief Summary
This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
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 Analysis of system accuracy based on DIN EN ISO 15197 day 1 Assessment of the analytical measurement performance of 5 blood glucose montoring systems based on procedures defined in DIN EN ISO 15197
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut für Diabetes Karlsburg GmbH
🇩🇪Karlsburg, Mecklenburg Vorpommern, Germany