No specific disease is investigated. The aim of the study is the production of universally applicable whole blood control samples that can be used, for example, for external quality control of glucose measurement systems.
Conditions
Interventions
Group 1: In this study, blood is taken from the vein of the arm. Part of the blood is used to obtain a blood count with determination of various laboratory values and an additional test for hepatitis
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: - You have to be able to understand the study plan and willing to follow the study procedures - Signed informed consent form
Exclusion criteria
Exclusion criteria: - Known infection with hepatitis B, C or HIV - Female participants: pregnancy (as determined by urine pregnancy test), lactation period - Known anemia or iron deficiency - Serious acute or chronic disease or an anamnesis that, in the opinion of investigator, could pose a risk to the participant, e.g., seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, acute infection - Intake of oxidizing substances - Known coagulation disorder - Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with study procedures, e.g., mental or visual incapacity, language barriers, alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reproducibility of glucose measurement results that have been obtained with range of glucose measurement systems. This assessment will be done for each system and each concentration level separately. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following exploratory endpoints are currently planned: • Donor variability • Differences between measurement systems | — |
Countries
Germany
Contacts
Public ContactStefan Pleus
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed