E14
Conditions
Interventions
Group 1: Blood samples from at least 100 different participants are collected. The samples' blood sugar levels are determined with each of the investigated blood glucose monitoring system. In addition
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.
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of measurement results within ±15 mg/dl (for 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