System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care

Institut fur Diabetes Karlsburg GmbH

Status: Completed

Conditions: Diabetes

Treatments: Diagnostic Test: blood glucose measuremen reference; Diagnostic Test: blood glucose measuremen subject

Study type: Interventional

Funder types: Other

Identifiers

NCT06037551

2023_005

Details and patient eligibility

About

This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Subject glucometer measurement

Experimental group

Description:

Blood glucose measurement BGM for personal use

Treatment:

Diagnostic Test: blood glucose measuremen subject

Diagnostic Test: blood glucose measuremen reference

glucometer measurement

Experimental group

Description:

evaluation of repeatability measurement precision

Treatment:

Diagnostic Test: blood glucose measuremen reference