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ser performance evaluation of 4 blood glucose monitoring systems based on ISO 15197:2013 / EN ISO 15197:2015

Not Applicable
Conditions
E14
Unspecified diabetes mellitus
Registration Number
DRKS00028602
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
112
Inclusion Criteria

Signed informed consent form
- Subjects are legally competent and capable to understand character, meaning and consequences of the study.

Exclusion Criteria

- Pregnancy or lactation period if venous samples are needed
- Severe acute disease that compromises the subject’s capability to participate in the study (at the study physician’s discretion)
- Severe chronic disease with potential risk during the test procedures (at the study physician’s discretion)
- Medical relevant anemia
- Suspected lack of compliance
- Dependence on investigator or sponsor

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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