Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Bolus
Item
basal-bolus treatment for at least 3 months
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi) less than or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin) less than or equal to 12.0%
boolean
C0202054 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Investigational New Drugs
Item
receipt of any trial drug within 1 month prior to this trial
boolean
C0013230 (UMLS CUI [1])
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 barriers precluding adequate understanding or cooperation
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])
Condition Interferes with Study Subject Participation Status | Proliferative retinopathy | Disorder of macula of retina Treatment required for | Recurrent severe hypoglycemia | Liver Dysfunction | Renal Insufficiency | Cardiac problem | Uncontrolled hypertension
Item
conditions that may interfere with trial participation as judged by investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0339467 (UMLS CUI [2])
C0730362 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0342316 (UMLS CUI [4])
C0086565 (UMLS CUI [5])
C1565489 (UMLS CUI [6])
C0262402 (UMLS CUI [7])
C1868885 (UMLS CUI [8])