Hematocrit Effect on a Blood Glucose Monitor

Institut fur Diabetes Karlsburg GmbH

Status: Completed

Conditions: Diabetes Mellitus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05158478

IDK_ISO_2021_005

Details and patient eligibility

About

This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197

Full description

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

Enrollment: 1 patient

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)

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1 participants in 1 patient group

Subject glucometer measurement

Experimental group

Treatment:

Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use

Diagnostic Test: blood glucose measurement, laboratory reference device