Diabetes
Conditions
Keywords
System Accuracy, Performance Evaluation by the User, DIN EN ISO 15197
Brief summary
This study assesses the system accuracy and performance evaluation by the user of a blood glucose monitoring system pursuant to ISO 15197
Interventions
DIAGNOSTIC_TESTGlucometer Test
blood glucose measurement using finger tip capillary blood using BGM and reference method
Sponsors
Institut fur Diabetes Karlsburg GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of system accuracy based on DIN EN ISO 15197 | Day 1 | Assessment of the analytical measurement performance of the blood glucose monitor in accordance with DIN EN ISO 15197, section 6.3 |
Countries
Germany
Contacts
STUDY_DIRECTOREckhard Salzsieder, PhD
Institut fur Diabetes Karlsburg GmbH
Outcome results
None listed