E14
Conditions
Sponsors
TERUMO EUROPE NV
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Signed informed consent form - Subjects are legally competent and capable to understand character, meaning and consequences of the study. If blood glucose values 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
Exclusion criteria: - Pregnancy or lactation period - Severe acute disease that compromises the subject’s capability to participate in the study (at the study physician’s discretion) - Severe chronic disease with potential risk during the test procedures (at the study physician’s discretion) - Suspected lack of compliance - Other preconditions, that could compromise the quality of the measurement results (e.g., intake of interfering substances, varying glucose values) - Dependence 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 or cerebral events, peripheral arterial occlusive disease or hypoglycemia unawareness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The evaluation is carried out based onthe requirements of the ISO 15197:2013 / EN ISO 15197:2015 standard. Primary objective is the glucose concentration in method comparison with a comparison method for the system accuracy and user performance evaluation or in measurement value comparison within the BGMS for the evaluation of precision and influence quantities. These are the absolute or relative deviations of the measured values between the investigational product and the comparison method, as well as the agreement rates, i.e. proportions of deviations within predefined deviation limits (method comparison) or the characterization of the distribution of the measured values (measurement value comparison). | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, the systematic measurement deviation (bias) between the measured values determined with the investigational product and the measured values determined with the comparison method is determined. Secondary variables are also evaluations of the instructions for use and the user interface the measuring systems (determined by a questionnaire). | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed