Diabetes Mellitus
Conditions
Brief summary
This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.
Interventions
DIAGNOSTIC_TESTblood glucose measurement: POCT
measurement of blood glucose concentration using 5 different POCT glucometer
DIAGNOSTIC_TESTblood glucose measurement: reference
measurement of blood glucose concentration using 2 different laboratory analyzer
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
Yes
Inclusion criteria
* 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 criteria
* 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
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 5 blood glucose montoring systems based on procedures defined in DIN EN ISO 15197 |
Countries
Germany
Outcome results
None listed