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

Launched by INSTITUT FÜR DIABETES-TECHNOLOGIE FORSCHUNGS- UND ENTWICKLUNGSGESELLSCHAFT MBH AN DER UNIVERSITÄT ULM · Mar 15, 2017

Keywords

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Gender

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Eligibility criteria

• 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