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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus

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

External Links

•   Blood sugar
•   ISO 15197