System Accuracy of BGM GL22
Study Details
Study Description
Brief Summary
This study assesses the system accuracy of a blood glucose monitoring system pursuant to ISO 15197
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Subject glucometer measurement
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Diagnostic Test: Glucometer Test
blood glucose measurement using finger tip capillary blood using BGM
Diagnostic Test: Refernce Measurement
blood glucose measurement using finger tip capillary blood using reference method
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Outcome Measures
Primary Outcome Measures
- Analysis of system accuracy based on DIN EN ISO 15197 [Day 1]
Assessment of the analytical measurement performance of the blood glucose monitor
Eligibility Criteria
Criteria
Inclusion criteria:
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Male or female patients with hypo-, eu- or hyperglycaemia
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The written informed consent had to be signed
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The volunteers must be older than 18 years
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The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved
Exclusion criteria:
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Pregnancy or lactation
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Acute or chronic diseases with the risk of aggravation by the measure
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A current constitution that does not allow participating in the study
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Participation in another study or activity with the blood glucose measuring system evaluated in the present study
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Application of substances listed in Appendix A of DIN EN ISO 15197:2015
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Institut für Diabetes Karlsburg GmbH | Karlsburg | Mecklenburg Vorpommern | Germany | 17495 |
Sponsors and Collaborators
- Institut fur Diabetes Karlsburg GmbH
Investigators
- Study Director: Kerstin Rebrin, PhD, Institut fur Diabetes Karlsburg GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023_004