NCT05158478

Hematocrit Effect on a Blood Glucose Monitor

Evaluation of the Hematocrit Effect on the Blood Glucose Monitor for Personal Use JT100

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Institut fur Diabetes Karlsburg GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood glucose measurement, blood glucose monitor for personal use	measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)
DIAGNOSTIC_TEST	blood glucose measurement, laboratory reference device	measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)

Timeline

• Start date: 2022-02-22
• Primary completion: 2022-02-22
• Completion: 2022-03-14
• First posted: 2021-12-15
• Last updated: 2022-07-28

Locations

1 site across 1 country: Germany