System Accuracy of BGM GL22

NCT ID: NCT06146933

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2023-11-24

Brief Summary

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

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subject glucometer measurement

Group Type EXPERIMENTAL

Glucometer Test

Intervention Type DIAGNOSTIC_TEST

blood glucose measurement using finger tip capillary blood using BGM

Refernce Measurement

Intervention Type DIAGNOSTIC_TEST

blood glucose measurement using finger tip capillary blood using reference method

Interventions

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Glucometer Test

blood glucose measurement using finger tip capillary blood using BGM

Intervention Type DIAGNOSTIC_TEST

Refernce Measurement

blood glucose measurement using finger tip capillary blood using reference method

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut fur Diabetes Karlsburg GmbH

OTHER

Sponsor Role lead

Responsible Party

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Matthes Kenning

Dr. Kerstin Rebrin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kerstin Rebrin, PhD

Role: STUDY_DIRECTOR

Institut fur Diabetes Karlsburg GmbH

Locations

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Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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2023_004

Identifier Type: -

Identifier Source: org_study_id