System Accuracy Evaluation of Karajishi Contour and Karajishi TS Blood Glucose Monitoring Systems Following ISO 15197:2013

Study Overview
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Brief Summary
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The study consists of 2 parts: The objective of part 1 of this study is the performance of a short evaluation of system accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure that the Karajishi meters are fully functioning, assure and document the accuracy of the comparison method, evaluate and validate the processes and procedures of the study methodology. The objective of part 2 of this study is the evaluation of system accuracy following ISO 15197:2013 (E), 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. This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer: Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.

Official Title
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System Accuracy Evaluation of Karajishi Contour and Karajishi TS Blood Glucose Monitoring Systems Following ISO 15197:2013

Conditions
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Diabetes

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


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 no diabetes For provoked blood glucose excursions due to insulin dose adjustment: Male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy. Minimum age of 18 years Signed informed consent form Legally competent and capable to understand character, meaning and consequences of the study 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) Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) Incapability of giving informed consent < 18 years Legally incompetent Accommodated in an institution (e.g. psychiatric clinic) Language barriers potentially compromising an adequate compliance with study procedures Dependent from investigator or sponsor For provoked blood glucose excursions 50 - 80 mg/dl: Coronary heart disease Condition after myocardial infarction Cerebral incidence 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Blood glucose monitoring systems for self-testing|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of System Accuracy according to ISO 15197 (see description) | System accuracy criteria: Following 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. Applying ISO 15197:2003 accuracy criteria: 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 < 75 mg/dl (4.2 mmol/l) or within ± 20 % at glucose concentrations ≥ 75 mg/dl (4.2 mmol/l). | For each subject, the experimental phase has an expected duration of up to 6 hours |