Status:
COMPLETED
System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus
Lead Sponsor:
B. Braun Melsungen AG
Collaborating Sponsors:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the...
Eligibility Criteria
Inclusion
- Subjects with type 1 or type 2 diabetes and healthy subjects
- Signed and dated informed consent form
- For small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy) or insulin pump therapy (continuous subcutaneous insulin infusion)
Exclusion
- Pregnancy or lactation period
- Severe acute illness that in the opinion of the investigating physician might confound the results of the test or which could result in a risk to the patient caused by the test
- Mental incapacity or language barriers precluding adequate compliance with the test procedures
- Severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the patient caused by the test
- Legal incompetence or limited legal competence
- Dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)
- For user performance evaluation: Subjects having used the test systems before themselves or having participated in a study with these Blood Glucose Monitoring Systems
- For system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease- or impaired hypoglycaemia awareness
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT02290067
Start Date
October 1 2014
End Date
November 1 2014
Last Update
December 23 2014
Active Locations (1)
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1
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft
Ulm, Germany, 89081