Diabetes Mellitus
Conditions
Brief summary
This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197
Detailed description
This study assesses the repeatability precision the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines
Interventions
measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)
DIAGNOSTIC_TESTblood glucose measurement, laboratory reference device
measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)
Sponsors
Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
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 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 |
|---|---|---|
| repeatability precision | 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