Status:
COMPLETED
System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore
Lead Sponsor:
Institut fur Diabetes Karlsburg GmbH
Collaborating Sponsors:
Beurer GmbH
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197
Detailed Description
This study assesses the system accuracy the blood glucose monitoring systems for personal use GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.
Eligibility Criteria
Inclusion
- Male or female patients with clinical indication for blood glucose testing
- Signed form of consent
- Minimum age of 18 years
- Subjects are legally competent and capable to understand character, meaning and consequences of the study
Exclusion
- Pregnancy or lactation
- Severe acute disease (at study physician's discretion)
- Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
- Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
- Being unable to give informed consent
- Age younger than 18 years
- Legally incompetent
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2022
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT05195567
Start Date
February 17 2022
End Date
March 18 2022
Last Update
April 4 2022
Active Locations (1)
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1
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, Germany, 17495