Status:
COMPLETED
Performance Evaluation by the User of BGM Contour Care According to ISO 15197:2015
Lead Sponsor:
Institut fur Diabetes Karlsburg GmbH
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Performance Evaluation by the User of the Blood Glucose Monitoring SystemContour Care in accordance with DIN EN ISO 15197:2015
Eligibility Criteria
Inclusion
- Male or female patients with clinical indication for blood glucose measurements (i.e. Diabetes mellitus)
- Male or female patients with hypo-, eu- or hyperglycemia
- The written informed consent had to be signed
- The volunteers must be older than 18 years
- The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved
Exclusion
- Pregnancy or lactation
- Acute or chronic diseases that
- pose a risk of aggravation by the measure
- pose a health hazard to the personnel
- A current constitution that does not allow participating in the study
- Participation in another study or activity with the blood glucose measuring system evaluated in the present study
- Application of substances listed in Appendix A of DIN EN ISO 15197:2015
Key Trial Info
Start Date :
June 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT06937736
Start Date
June 20 2024
End Date
July 23 2024
Last Update
April 22 2025
Active Locations (1)
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1
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, Germany, 17495