Status:
COMPLETED
System Accuracy of BGM GL60
Lead Sponsor:
Institut fur Diabetes Karlsburg GmbH
Collaborating Sponsors:
Beurer GmbH
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197
Detailed Description
This study assesses the system accuracy ofthe blood glucose monitoring systems for personal use GL60 as outlined in DIN EN ISO 15197:2015.
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 :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT06037486
Start Date
October 17 2022
End Date
November 15 2022
Last Update
September 14 2023
Active Locations (1)
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1
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, Germany, 17495