Status:
COMPLETED
System Accuracy of 12 Bloog Glucose Monitoring Systems
Lead Sponsor:
Institut fur Diabetes Karlsburg GmbH
Collaborating Sponsors:
Aktivmed GmbH
Beurer GmbH
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT05219526
Start Date
January 3 2022
End Date
December 31 2022
Last Update
September 8 2023
Active Locations (1)
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1
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, Germany, 17495