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NCT05219526 Clinical Trial

System Accuracy of 12 Bloog Glucose Monitoring Systems

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05219526
Other study ID # IDK_2021_006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2022
Est. completion date December 31, 2022

Study information
Verified date September 2023
Source Institut fur Diabetes Karlsburg GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 700
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• blood glucose measurement: BGM
measurement of blood glucose concentration using different BGM
• blood glucose measurement: reference method
measurement of blood glucose concentration using reference Method

Locations
Country Name City State
Germany Institut für Diabetes Karlsburg GmbH Karlsburg Mecklenburg Vorpommern

Sponsors (5)
Lead Sponsor Collaborator
Institut fur Diabetes Karlsburg GmbH Aktivmed GmbH, Beurer GmbH, IME-DC GmbH, Medisana GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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