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Completed

NCT Number: NCT05219526

System Accuracy of 12 Bloog Glucose Monitoring Systems

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.

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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: No

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: BGM

Diagnostic Test

measurement of blood glucose concentration using different BGM

blood glucose measurement: reference method

Diagnostic Test

measurement of blood glucose concentration using reference Method

Primary outcomes

  1. Measurement performance: System accuracy

    Time frame: 4-6 hours

    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

Sponsors and collaborators

Lead sponsor

Institut fur Diabetes Karlsburg GmbH

Other

Collaborators

  • Aktivmed GmbH
  • Beurer GmbH
  • IME-DC GmbH
  • Medisana GmbH

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2022
Registry last updated
Sep 8, 2023

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.

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