Evaluating System Accuracy and User Performance of Omnitest® Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus
Not Applicable
Terminated
- Conditions
- Diabetes
- Registration Number
- NCT02439177
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
The aim of this study is to determine the System Accuracy and User Performance evaluation of the mentioned BGM systems by gaining a sufficient amount of measured data from capillary blood.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Male or female subjects with type 1 or type 2 diabetes, for the evaluation of System Accuracy also healthy subjects
- Age ≥ 18
- 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 - I.C.T.) or insulin pump therapy (continuous subcutaneous insulin infusion - C.S.I.I.)
Exclusion Criteria
- 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 subject caused by the test.
- 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 subject caused by the test.
- Mental incapacity or language barriers precluding adequate compliance with the test procedures
- Legal incompetence or limited legal competence
- Dependency from the Sponsor or the clinical Investigator (e.g. co-workers of the Sponsor or the clinical research centre)
- For User Performance evaluation: Subjects having participated in a study with Omnitest® 5 before.
- 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
- Anamnestically relevant amounts of interfering substances in the blood, following labelling in the instructions for use as reviewed and evaluated by a physician during screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment up to 7 hours User Performance of blood glucose monitoring system indicated by patient up to 7 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
🇩🇪Ulm, Germany
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm🇩🇪Ulm, Germany