Informed Consent Parent
Item
parents' informed consent (ic) obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
Informed Consent Child
Item
obtained child's assent (when possible)
boolean
C0021430 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Insulin detemir | Insulin Aspart | Injection Mixed | Injection Separate
Item
treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections
boolean
C0537270 (UMLS CUI [1])
C1708521 (UMLS CUI [2])
C1533685 (UMLS CUI [3,1])
C0205430 (UMLS CUI [3,2])
C1533685 (UMLS CUI [4,1])
C0443299 (UMLS CUI [4,2])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin a1c) lesser than or equal to 8.6%
boolean
C0202054 (UMLS CUI [1])
Chronic Alcoholic Intoxication Informed Consent Invalid | Drug abuse Informed Consent Invalid | Mental disorders Informed Consent Invalid | Personality Disorders Informed Consent Invalid | Chronic Alcoholic Intoxication Preventing Protocol Compliance | Drug abuse Preventing Protocol Compliance | Mental disorders Preventing Protocol Compliance | Personality Disorders Preventing Protocol Compliance
Item
history of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
boolean
C0001973 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1547465 (UMLS CUI [1,3])
C0013146 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C1547465 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C1547465 (UMLS CUI [3,3])
C0031212 (UMLS CUI [4,1])
C0021430 (UMLS CUI [4,2])
C1547465 (UMLS CUI [4,3])
C0001973 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0013146 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0031212 (UMLS CUI [8,1])
C1292733 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
Mental handicap Excludes Comprehension Study Protocol | Comprehension Study Protocol Unwilling | Language problems Exclude Comprehension Study Protocol | Mental handicap Excludes Compliance behavior | Compliance behavior Unwilling | Language problems Exclude Compliance behavior
Item
mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1405458 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0162340 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C1306341 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
C1321605 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C1405458 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
Change of medication Interferes with Glucose metabolism | Pharmaceutical Preparations New Interfere with Glucose metabolism | Adrenal Cortex Hormones Systemic U/day
Item
anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
boolean
C0580105 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0596620 (UMLS CUI [2,4])
C0001617 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
any other condition that the investigator (trial physician) feels would interfere with trial participation or evaluation of results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])