Status:
COMPLETED
System Accuracy of 14 Blood Glucose Monitoring Systems
Lead Sponsor:
Institut fur Diabetes Karlsburg GmbH
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The system accuracy of 14 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 over thr courese of 24 months
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female patients with hypo-, eu- or hyperglycaemia
- 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 criteria:
- Pregnancy or lactation
- Acute or chronic diseases with the risk of aggravation by the measure
- 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
Exclusion
Key Trial Info
Start Date :
March 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06037499
Start Date
March 3 2023
End Date
January 1 2025
Last Update
April 25 2025
Active Locations (1)
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1
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, Germany, 17495