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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: Blood glucose monitoring system (Omnitest 3)
* Device: Blood glucose monitoring system (Omnitest 5)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omnitest 3<br>Blood glucose monitoring system | Device: Blood glucose monitoring system (Omnitest 3)<br> <br> |
| Experimental: Omnitest 5<br>Blood glucose monitoring system | Device: Blood glucose monitoring system (Omnitest 5)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose monitoring system, System Accuracy