System Accuracy of BGM GL60

Institut fur Diabetes Karlsburg GmbH

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Diagnostic Test: Glucometer Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06037486

2022_002

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 ofthe blood glucose monitoring systems for personal use GL60 as outlined in DIN EN ISO 15197:2015.

Enrollment: 101 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Subject glucometer measurement

Experimental group

Treatment:

Diagnostic Test: Glucometer Test