Status:

COMPLETED

User Evaluation of BGM JS200B

Lead Sponsor:

Institut fur Diabetes Karlsburg GmbH

Conditions:

Diabetes

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Performance Evaluation by the User of the Blood Glucose Monitoring System JS200B in accordance with DIN EN ISO 15197:2015

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Male or female patients with hypo-, eu- or hyperglycaemia
  • The written informed consent had to be signed
  • The volunteers must be older than 18 years
  • The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved
  • Exclusion criteria:
  • Pregnancy or lactation
  • Acute or chronic diseases with the risk of aggravation by the measure
  • A current constitution that does not allow participating in the study
  • Participation in another study or activity with the blood glucose measuring system evaluated in the present study
  • Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Exclusion

    Key Trial Info

    Start Date :

    April 19 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 23 2023

    Estimated Enrollment :

    100 Patients enrolled

    Trial Details

    Trial ID

    NCT06037538

    Start Date

    April 19 2023

    End Date

    May 23 2023

    Last Update

    September 14 2023

    Active Locations (1)

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    Institut für Diabetes Karlsburg GmbH

    Karlsburg, Mecklenburg-Vorpommern, Germany, 17495