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Completed

NCT Number: NCT05195567

System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

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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–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

About this study

This study assesses the system accuracy the blood glucose monitoring systems for personal use GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients with clinical indication for blood glucose testing
  • Signed form of consent
  • 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
  • Severe acute disease (at study physician's discretion)
  • Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
  • Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
  • Being unable to give informed consent
  • Age younger than 18 years
  • Legally incompetent

Treatment and study plan

Glucometer Test

Diagnostic Test

measurement of the blood glucose concentration using the blood glucose monitor for personal use

blood glucose measurement, laboratory reference device

Diagnostic Test

measurement of the blood glucose concentration using a laboratory reference device

Primary outcomes

  1. Analysis of system accuracy based on DIN EN ISO 15197

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

Institut fur Diabetes Karlsburg GmbH

Other

Collaborators

  • Beurer GmbH

Registry information

Official study title

Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GlucoSpark / GlucoScore gemäß DIN EN ISO 15197:2015.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2022
Registry last updated
Apr 4, 2022

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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