E14
Conditions
Sponsors
Institut für Diabetes-Technologie Ulm GmbH (IfDT)
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 - Condition after cerebral events - Peripheral arterial occlusive disease - Hypoglycemia unawareness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration in comparison with a reference method for evaluating accuracy and performance evaluation by the user or in comparison of measured values within the respective measurement systems for precision measurements and interference. This is the absolute or relative deviation of the measured values between the investigational system and the reference method, as well as agreement rates, i.e. proportions of deviations within predefined deviation limits (method comparison) or the charcacterisation of the distribution of the measured values. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, other variables can be defined, e.g. the systematic measurement deviation (bias) between the measured values determined by the investigational system and the measured values determined by the reference method or the reference device. Secondary variables can also be evaluations of the instructions for use or the investigational systems (determination by means of questionnaires), errors in handling or various disturbances such as "contamination of the fingers" during capillary blood measurements. | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed