Assessment of Blood Glucose Monitoring Systems

Overview

System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013

Full Title of Study: “Leistungsbewertung Von Blutzuckermesssystemen im Methodenvergleich”

Study Type

  • Study Type: Interventional
  • Study Primary Completion Date: December 2013

Interventions

  • Device: Blood glucose monitoring systems

Clinical Trial Outcome Measures

Primary Measures

  • Analysis of system accuracy
    • Time Frame: for each subject, the experimental phase has an expected duration of up to 6 hours

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years of age or older – Male or female subjects with type 1 or type 2 diabetes or healthy subjects – For BG adjustment people with type 1 diabetes Exclusion Criteria:

  • Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient – Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient – Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study – For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness – Legal incompetence or limited legal competence – Age < 18 years – Dependency from the sponsor or the clinical investigator – Mental incapacity or language barriers precluding adequate compliance with the study procedures

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
  • Collaborator
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

Freckmann G, Link M, Schmid C, Pleus S, Baumstark A, Haug C. System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods. Diabetes Technol Ther. 2015 Sep;17(9):635-48. doi: 10.1089/dia.2015.0085. Epub 2015 Jun 25.

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