NCT05195567

System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GlucoSpark / GlucoScore gemäß DIN EN ISO 15197:2015.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Institut fur Diabetes Karlsburg GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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 GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Glucometer Test	measurement of the blood glucose concentration using the blood glucose monitor for personal use
DIAGNOSTIC_TEST	blood glucose measurement, laboratory reference device	measurement of the blood glucose concentration using a laboratory reference device

Timeline

• Start date: 2022-02-17
• Primary completion: 2022-03-09
• Completion: 2022-03-18
• First posted: 2022-01-19
• Last updated: 2022-04-04

Locations

1 site across 1 country: Germany