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System Accuracy of the Blood Glucose Monitor for Personal Use JT100

I

Institut fur Diabetes Karlsburg GmbH

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Diagnostic Test: blood glucose measurement, laboratory reference device
Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use

Study type

Interventional

Funder types

Other

Identifiers

NCT05124834
IDK_ISO_2021_004

Details and patient eligibility

About

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

Full description

This study assesses the system accuracy the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines

Enrollment

114 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

114 participants in 1 patient group

Subject glucometer measurement
Experimental group
Description:
Blood glucose measurement BGM for personal use
Treatment:
Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use
Diagnostic Test: blood glucose measurement, laboratory reference device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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