Performance Evaluation by the User of BGM Contour Care According to ISO 15197:2015
NCT ID: NCT06937736
Last Updated: 2025-04-22
Study Results
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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COMPLETED
NA
101 participants
INTERVENTIONAL
2024-06-20
2024-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Subject glucometer measurement
Blood glucose measurement BGM for personal use
blood glucose measurement by subject
blood glucose measurement by subject using finger tip capillary blood
Interventions
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blood glucose measurement by subject
blood glucose measurement by subject using finger tip capillary blood
Eligibility Criteria
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Inclusion Criteria
* Male or female patients with hypo-, eu- or hyperglycemia
* 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
* Acute or chronic diseases that
* pose a risk of aggravation by the measure
* pose a health hazard to the personnel
* 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
18 Years
ALL
No
Sponsors
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Institut fur Diabetes Karlsburg GmbH
OTHER
Responsible Party
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Principal Investigators
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Eckhard Salzsieder, PhD
Role: STUDY_DIRECTOR
Institut fur Diabetes Karlsburg GmbH
Locations
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Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, Germany
Countries
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Other Identifiers
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2024_002
Identifier Type: -
Identifier Source: org_study_id
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