Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Healthy Volunteers
Item
subjects with type 1 or type 2 diabetes and healthy subjects
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C1708335 (UMLS CUI [3])
Informed Consent
Item
signed and dated informed consent form
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Insulin regime With intensity | Insulin pump Therapy | Continuous subcutaneous infusion of insulin
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) or insulin pump therapy (continuous subcutaneous insulin infusion)
boolean
C0011854 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C1140609 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0393124 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnancy or lactation period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Acute illness Severe Interferes with Research results | Acute illness Severe Study Subject Participation Status At risk
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 patient caused by the test
boolean
C4061114 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C4061114 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
Mental handicap Excludes Compliance Tests | Language Barriers Exclude Compliance Tests
Item
mental incapacity or language barriers precluding adequate compliance with the test procedures
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,4])
C0237167 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0022885 (UMLS CUI [2,4])
Chronic disease Severe Interferes with Research results | Chronic disease Severe Study Subject Participation Status At risk | Exception Diabetes Mellitus
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 patient caused by the test
boolean
C0008679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0011849 (UMLS CUI [3,2])
Legal competency Lacking | Legal competency Limited
Item
legal incompetence or limited legal competence
boolean
C0680554 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0680554 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Coworker Clinical Study Sponsor | Coworker Clinical Research Center
Item
dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)
boolean
C0681088 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
C0681088 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C1552416 (UMLS CUI [2,3])
Study Subject Participation Status | Blood glucose monitoring
Item
for user performance evaluation: subjects having used the test systems before themselves or having participated in a study with these blood glucose monitoring systems
boolean
C2348568 (UMLS CUI [1])
C3669205 (UMLS CUI [2])
Coronary heart disease | Myocardial Infarction | Event cerebral | Peripheral arterial occlusive disease | Loss of hypoglycemic warning
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
C0010068 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C0006104 (UMLS CUI [3,2])
C1306889 (UMLS CUI [4])
C0342317 (UMLS CUI [5])