E14
Conditions
Sponsors
Institut für Diabetes-Technologie Ulm GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Signed informed consent. Subjects are legally competent and capable of understanding the nature, significance, and implications 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 conditions which might compromise the quality of measurement results (e. g. intake of potential interfering substances, instable 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 |
|---|---|
| The primary endpoint is a method comparison between the investigated devices and a comparator method. The method comparison will be based on glucose concentrations obtained in different sample types with different BGMSs and laboratory analyzers, both in absolute values and relative to the measurement results of the comparison system. Specifically, qualitative and quantitative differences will be addressed in the method comparison. | — |
Secondary
| Measure | Time frame |
|---|---|
| For blood-glucose monitoring systems whose intended use includes self-monitoring by lay users, system accuracy will be assessed based on the accuracy requirements of ISO 15197:2013 | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Ulm GmbH
Outcome results
None listed