System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Diagnostic Test: Glucometer Test; Diagnostic Test: blood glucose measurement, laboratory reference device

• Registration Number: NCT05195567
• Lead Sponsor: Institut fur Diabetes Karlsburg GmbH

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

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-19
• Study Start: 2022-02-17
• Status Verified: 2022-03
• Primary Completion: 2022-03-09
• Study Completion: 2022-03-18
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subject glucometer measurement	blood glucose measurement, laboratory reference device	-
Subject glucometer measurement	Glucometer Test	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut für Diabetes Karlsburg GmbH; 🇩🇪 Karlsburg, Mecklenburg Vorpommern, Germany