E14
Conditions
Sponsors
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (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 if venous samples are needed - 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) - Medical relevant anemia - Suspected lack of compliance - Dependence on investigator or sponsor - If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy: - Pregnancy or lactation period - 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 |
|---|---|
| Percentage of measurement results within ±15 mg/dl (für blood glucose concentrations <100 mg/dl) or within ±15% (=100 mg/dl) of comparison measurement results | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of results within zones A and B of the Consensus Error Grid | — |
Countries
Germany
Contacts
Public ContactStefan Pleus
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed