Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)

Study Overview
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Brief Summary
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The objective of this study is the evaluation of system accuracy based on EN ISO 15197:2015 (ISO 15197:2013), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. ISO 15197:20132 was harmonized with the regulations of the European Union as EN ISO 15197:2015. This harmonization had no impact on the requirements and procedu¬res in ISO 15197:2013; changes were made to the foreword and an informative annex. In this study, system accuracy evaluation will be performed for OneTouch® Verio Flex (LifeScan Europe) on behalf of LifeScan Scotland Limited (customer) with three different reagent system lots.

Official Title
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Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Blood glucose monitoring systems for self-testing (BGMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, with type 1 diabetes, type 2 diabetes (or subjects without diabetes) Signed informed consent form Minimum age of 18 years Subjects are legally competent and capable to understand character, meaning and consequences of the study. If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy: Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy. Signature of subjects to document consent with these procedures on informed consent form. Exclusion Criteria: Pregnancy or lactation period Severe acute disease (at the study physician's discretion) Severe chronic disease with potential risk during the test procedures (at the study physician's discretion) Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) Being unable to give informed consent < 18 years Legally incompetent Being committed to an institution (e.g. psychiatric clinic) Language barriers potentially compromising an adequate compliance with study procedures Dependent on investigator or sponsor If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2), subjects with type 1 diabetes, suffering from: Coronary heart disease Condition after myocardial infarction Condition after cerebral events Peripheral arterial occlusive disease Hypoglycemia unawareness

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood glucose measurement<br> | Device: Blood glucose monitoring systems for self-testing (BGMS)<br>* Measurement procedure Subjects will be asked to wash and dry their hands before the measurements. The measurement procedure for each reagent system lot of a BGMS will be as follows: Study personnel will collect a capillary blood sample from the subject's fingertip by skin puncture. Duplicate measurements on the sample will be consecutively performed with 2 test meters using reagent system units from the same vial / package. Capillary blood for measurements with all 3 test strip lots and for both comparison measurements will be taken from the same finger puncture. The sample will be applied to the reagent system units following specifications in the manufacturer's labelling.<br>* Other names: OneTouch® Verio Flex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System accuracy criteria | Based on EN ISO 15197:2015 (ISO 15197:2013) (E), the BGMS shall meet both of the following criteria: Criterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations < 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l). Each lot shall pass acceptability criterion A. Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes. | For each subject, the experimental phase has an expected duration of up to 6 hours |