Pilot study to investigate glucose concentrations in people without diabetes mellitus during oral glucose tolerance test (oGTT)
Not Applicable
- Conditions
- E14Unspecified diabetes mellitus
- Registration Number
- DRKS00026765
- Lead Sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Signed informed consent form
- Subjects are legally competent and capable to understand character, meaning and consequences of the study
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method no predefined secondary endpoint