Diabetes
Conditions
Keywords
Blood glucose monitoring system, System Accuracy
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.
Interventions
Sponsors
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
B. Braun Melsungen AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed