Evaluating System Accuracy and User Performance of Omnitest® Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus

Overview

The aim of this study is to determine the System Accuracy and User Performance evaluation of the mentioned BGM systems by gaining a sufficient amount of measured data from capillary blood.

Full Title of Study: “Evaluating System Accuracy and User Performance of Omnitest® Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2015

Interventions

  • Device: Blood glucose monitoring system (Omnitest 3)
  • Device: Blood glucose monitoring system (Omnitest 5)

Arms, Groups and Cohorts

  • Experimental: Omnitest 3
    • Blood glucose monitoring system
  • Experimental: Omnitest 5
    • Blood glucose monitoring system

Clinical Trial Outcome Measures

Primary Measures

  • System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment
    • Time Frame: up to 7 hours
  • User Performance of blood glucose monitoring system indicated by patient
    • Time Frame: up to 7 hours

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female subjects with type 1 or type 2 diabetes, for the evaluation of System Accuracy also healthy subjects – Age ≥ 18 – Signed and dated informed consent form – For small modifications of the insulin doses to achieve certain blood glucose values (System Accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy – I.C.T.) or insulin pump therapy (continuous subcutaneous insulin infusion – C.S.I.I.) Exclusion Criteria:

  • Pregnancy or lactation period – Severe acute illness that, in the opinion of the investigating physician, might confound the results of the test or which could result in a risk to the subject caused by the test. – Severe chronic illness besides Diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the subject caused by the test. – Mental incapacity or language barriers precluding adequate compliance with the test procedures – Legal incompetence or limited legal competence – Dependency from the Sponsor or the clinical Investigator (e.g. co-workers of the Sponsor or the clinical research centre) – For User Performance evaluation: Subjects having participated in a study with Omnitest® 5 before. – For System Accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease or impaired hypoglycaemia awareness – Anamnestically relevant amounts of interfering substances in the blood, following labelling in the instructions for use as reviewed and evaluated by a physician during screening.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

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

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