Project for establishing control solutions for glucose measurement systems based on blood samples
- Conditions
- o 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.
- Registration Number
- DRKS00034618
- 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
- Pending
- Sex
- All
- Target Recruitment
- 50
You have to be able to understand the study plan and willing to follow the study procedures
- Signed informed consent form
- 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The following exploratory endpoints are currently planned: <br>•Donor variability<br>•Differences between measurement systems