Diabetes
Conditions
Brief summary
This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015
Interventions
DIAGNOSTIC_TESTblood glucose measuremen subject
measurement of the blood glucose concentration of subject using BGM and capillary finger tip blood
DIAGNOSTIC_TESTblood glucose measuremen reference
measurement of the blood glucose concentration of subject using reference method and capillary finger tip blood
Sponsors
Institut fur Diabetes Karlsburg GmbH
Study design
Allocation
RANDOMIZED
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 | 1 Day | Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197 |
Countries
Germany
Outcome results
None listed