Institut Fuer Diabetes-Technologie Surveillance Program

Study Overview
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Brief Summary
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Assessment of the system accuracy of different blood glucose monitoring systems available in Europe

Detailed Description
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A variety of blood glucose monitoring systems (BGMS) are available on the European market. For many of these BGMS, the system accuracy is unknown or it has not yet been assessed in manufacturer-independent studies. The IDT surveillance program aims at assessing the system accuracy of different BGMS that are available in Europe in a manufacturer-independent, investigator-initiated study. The initial study will cover 18 BGMS from 18 different manufacturers. Per BGMS, one test strip lot will be assessed based on procedures stated in the international standard ISO 15197:2013 / EN ISO 15197:2015.

Official Title
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Institut Fuer Diabetes-Technologie Surveillance Program for Blood Glucose Monitoring Systems in Europe

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 subjects without diabetes Signed informed consent form Minimum age of 18 years ubjects 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, 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

| Intervention/Treatment |
| --- |
|Device: Blood glucose monitoring systems for self-testing|Capillary blood samples will be used for the evaluation of system accuracy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of system accuracy based on ISO 15197 | Assessment of the analytical measurement performance of 18 blood glucose montoring systems based on procedures defined in ISO 15197 | For each subject, the experimental phase has an expected duration of up to 6 hours |