Diabetes Mellitus
Conditions
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 the blood glucose monitoring systems for personal use BG-709b as outlined in DIN EN ISO 15197:2015.
Interventions
measurement of the blood glucose concentration using the blood glucose monitor for personal use (BG-709b)
DIAGNOSTIC_TESTblood glucose measurement, laboratory reference device
measurement of the blood glucose concentration using a laboratory reference device
Sponsors
Hangzhou Sejoy Electronics & Instrument Co., ltd. Joytech Healthcare Co., ltd., PRC
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 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female patients with clinical indication for blood glucose testing * Signed form of consent * 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 * Severe acute disease (at study physician's discretion) * Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion) * Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197) * Being unable to give informed consent * Age younger than 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 the blood glucose monitor based on procedures defined in DIN EN ISO 15197 |
Countries
Germany
Outcome results
None listed