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NCT05031000 Clinical Trial

Blood Glucose Monitoring Systems: Discounter Versus Brand

Diabetes Mellitus Clinical Trial

Official title:
Cheap Equals Bad? Comparative System Accuracy of POCT Blood Glucose Monitoring Systems Under the Aspect of Aspect of Pricing: Discounter Versus Brand

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05031000
Other study ID # IDK_ISO_2021_002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2021
Est. completion date October 6, 2021

Study information
Verified date August 2021
Source Institut fur Diabetes Karlsburg GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date October 6, 2021
Est. primary completion date October 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
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: POCT
measurement of blood glucose concentration using 5 different POCT glucometer
• blood glucose measurement: reference
measurement of blood glucose concentration using 2 different laboratory analyzer

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

Sponsors (1)
Lead Sponsor Collaborator
Institut fur Diabetes Karlsburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis of system accuracy based on DIN EN ISO 15197 Assessment of the analytical measurement performance of 5 blood glucose montoring systems based on procedures defined in DIN EN ISO 15197 day 1
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