User Performance Evaluation of Contour® Plus One, Accu-Chek® Performa Connect, FreeStyle Optium Neo and OneTouch® Select Plus Blood Glucose Monitoring Systems Following ISO 15197:2013; EN ISO 15197:2015

Launched by INSTITUT FÜR DIABETES-TECHNOLOGIE FORSCHUNGS- UND ENTWICKLUNGSGESELLSCHAFT MBH AN DER UNIVERSITÄT ULM · Sep 23, 2016

Keywords

ClinConnect Summary

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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, subjects with type 1 diabetes, suffering from:
• • Coronary heart disease
• • Condition after myocardial infarction
• • Condition after cerebral events
• • Peripheral arterial occlusive disease
• • Hypoglycemia unawareness
• Inclusion and exclusion criteria defined by ISO 15197:2013; EN ISO 15197:2015:
• • Only subjects with diabetes type 1 or type 2 will be included.
• • Demographic data will be collected to demonstrate that subjects represent different ages, genders and education levels.
• • In deviation from ISO 15197:2013; EN ISO 15197:2015, included subjects may have participated in a study involving the BGMS, but must not yet have performed measurements with the BGMS according to their own statement for the last 3 years.
• • In addtition, included subjects did not use the BGMS being evaluated at home for the last 3 years according to their own statement.
• • In order to ensure that capillary blood samples meet the requirements indicated in the manufacturer's labelling,
• • a physician will review the subjects' anamnesis and medication and check for interfering substances indicated in the manufacturer's labelling.
• • the hematocrit value of each subject will be checked to be within the range indicated in the manufacturer's labelling (hematocrit determination before or after the measurement procedure).