E14
Conditions
Interventions
Sponsors
Eligibility
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: - History of known diabetes mellitus - Severe acute or chronic disease that compromises the subject’s capability to participate in the study (at the study physician’s discretion) - Current constitution of the subjects, which does not enable them to participate in the study (at the study physician’s discretion) - Pregnancy or lactation period - Known severe skin reactions to medicated patches - Blood donation in the last 2 months before the start of the study (according to the subject) - Language or other barriers that prevent a sufficient understanding of the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The statistical analysis is based on descriptive statistics: number of measurement results, mean value, standard deviation, minimum, median, maximum, further quantiles (e.g. quartiles). It is also counted how often the different preanalytical methods come to a positive or negative result in terms of diabetes diagnosis. If central estimates (i.e., mean or median) of the glucose concentration differ markedly, exploratory tests to check for statistically significant differences can be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| no predefined secondary endpoint | — |
Countries
Germany
Contacts
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)