System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

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

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: Glucometer Test; Diagnostic test: blood glucose measurement, laboratory reference device

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg Vorpommern
    • Karlsburg, Mecklenburg Vorpommern, Germany, 17495
      • Institut für Diabetes Karlsburg GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Subject glucometer measurement	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of system accuracy based on DIN EN ISO 15197	Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197	Day 1

Collaborators and Investigators

• Sponsor: Institut fur Diabetes Karlsburg GmbH
• Collaborators: Beurer GmbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2022
• Primary Completion (ACTUAL): March 9, 2022
• Study Completion (ACTUAL): March 18, 2022

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (ACTUAL): January 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IDK_ISO_2021_007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No