Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus

NCT ID: NCT01729546

Last Updated: 2015-01-14

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

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2012-11-30

Brief Summary

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In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and several POCT (point-of-care testing) devices against two laboratory methods will be performed. This evaluation will be performed according to ISO (International Organization for Standardization) 15197 System Accuracy.

Detailed Description

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Conditions

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Diabetes

Interventions

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7 Blood glucose monitoring systems

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* People with diabetes Typ 1 or Typ 2 and people without diabetes
* for BG adjustment people with diabetes Typ 1 or Typ 2
* informed consent

Exclusion Criteria

* pregnancy or lactation period
* severe acute diseases
* severe chronic diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, , Germany

Site Status

Countries

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Germany

References

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Freckmann G, Schmid C, Pleus S, Baumstark A, Link M, Stolberg E, Haug C, Sieber J. System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems. Clin Chem Lab Med. 2014 Jul;52(7):1079-86. doi: 10.1515/cclm-2013-0976.

Reference Type RESULT
PMID: 24681433 (View on PubMed)

Related Links

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Other Identifiers

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IDT-1212

Identifier Type: -

Identifier Source: org_study_id

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