System Accuracy and User Performance of 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 test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.

Official Title
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EVALUATING SYSTEM ACCURACY AND USER PERFORMANCE OF 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)
* Device: Blood glucose monitoring system (Omnitest 5D)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with type 1 or type 2 diabetes and healthy subjects 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) or insulin pump therapy (continuous subcutaneous insulin infusion) 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 patient caused by the test Mental incapacity or language barriers precluding adequate compliance with the test procedures 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 patient caused by the test Legal incompetence or limited legal competence Dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center) For user performance evaluation: Subjects having used the test systems before themselves or having participated in a study with these Blood Glucose Monitoring Systems 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

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 |
| --- | --- |
| Active Comparator: 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> |
| Experimental: Omnitest 5D<br>Blood glucose monitoring system | Device: Blood glucose monitoring system (Omnitest 5D)<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 6 hours | 
| User performance of blood glucose monitoring systems indicated by patient [questionnaire] |  | up to 4 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