gender
Item
male or female subjects with type 1 or type 2 diabetes, for the evaluation of system accuracy also healthy subjects
boolean
C0079399 (UMLS CUI [1])
age
Item
age ≥ 18
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
signed and dated informed consent form
boolean
C0021430 (UMLS CUI [1])
Continuous subcutaneous infusion of insulin; diabetes mellitus type 1
Item
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.)
boolean
C0393124 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0441729 (UMLS CUI [2,2])
pregnant; breast feeding
Item
pregnancy or lactation period
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Acute Disease
Item
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.
boolean
C0001314 (UMLS CUI [1])
Chronic disease
Item
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.
boolean
C0008679 (UMLS CUI [1])
Clinical Research; Disruption
Item
mental incapacity or language barriers precluding adequate compliance with the test procedures
boolean
C0008972 (UMLS CUI [1])
C0332453 (UMLS CUI [2])
legal incompetence
Item
legal incompetence or limited legal competence
boolean
C1301860 (UMLS CUI [1,1])
C0231189 (UMLS CUI [1,2])
Clinical Study Sponsor; dependent
Item
dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research centre)
boolean
C2347796 (UMLS CUI [1])
C3244310 (UMLS CUI [2])
evaluation
Item
for user performance evaluation: subjects having participated in a study with omnitest® 5 before.
boolean
C0220825 (UMLS CUI [1])
evaluation
Item
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
boolean
C0220825 (UMLS CUI [1])
screening; blood
Item
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.
boolean
C1409616 (UMLS CUI [1])
C0005767 (UMLS CUI [2])