System Accuracy of 12 Bloog Glucose Monitoring Systems

Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015

The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: blood glucose measurement: BGM; Diagnostic test: blood glucose measurement: reference method

• Study Type: Interventional
• Enrollment (Actual): 700
• 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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, with clinical indication for blood glucose measurement
• Signed informed consent form
• 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 period
• Severe acute disease (at the study physician's discretion)
• Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
• Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
• A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
• Being unable to give informed consent
• < 18 years
• Legally incompetent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subject BGMS measurement; Blood glucose measurement using BGMS	Diagnostic test: blood glucose measurement: BGM; measurement of blood glucose concentration using different BGM; Diagnostic test: blood glucose measurement: reference method; measurement of blood glucose concentration using reference Method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement performance: System accuracy	Assessment of the analytical measurement performance of blood glucose monitoring systems based on procedures defined in DIN EN ISO 15197 using results obtained from fingertip blood glucose measurements compared to a reference equipment	4-6 hours

Collaborators and Investigators

• Sponsor: Institut fur Diabetes Karlsburg GmbH
• Collaborators: Aktivmed GmbH; Beurer GmbH; IME-DC GmbH; Medisana GmbH
• Investigators: Study Director: Eckhard Salzsieder, PhD, Institut für Diabetes Karlsburg GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IDK_2021_006

Drug and device information, study documents

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