Blood Glucose Monitoring Systems: Discounter Versus Brand

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.

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood glucose measurement: POCT

Diagnostic Test

measurement of blood glucose concentration using 5 different POCT glucometer

blood glucose measurement: reference

Diagnostic Test

measurement of blood glucose concentration using 2 different laboratory analyzer

Primary outcomes

Analysis of system accuracy based on DIN EN ISO 15197

Time frame: day 1

Assessment of the analytical measurement performance of 5 blood glucose montoring systems based on procedures defined in DIN EN ISO 15197

Sponsors and collaborators

Lead sponsor

Institut fur Diabetes Karlsburg GmbH

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Sep 1, 2021
Registry last updated: Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed