Insulin-Dependent Diabetes Mellitus Disease length | Insulin regime
Item
subjects with type 1 diabetes treated with insulin for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2])
Body mass index
Item
bmi (body mass index) between 18.0-29.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Fasting C-peptide level Negative
Item
negative fasting c-peptide (below or equal to 0.6 ng/ml)
boolean
C2208720 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin a1c) below or equal to 10.0%
boolean
C0202054 (UMLS CUI [1])
Insulin regime Unit/kilogram/day
Item
current treatment with insulin below or equal to 1.2 u/kg/day
boolean
C0557978 (UMLS CUI [1,1])
C1532634 (UMLS CUI [1,2])
Good health Medical History | Good health Physical Examination | Good health Laboratory Results
Item
subject should be in good health based on medical history, physical examination and routine laboratory data
boolean
C3813622 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3813622 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3813622 (UMLS CUI [3,1])
C1254595 (UMLS CUI [3,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Suspected Pharmaceutical Preparations Similar | Hypersensitivity Investigational Medical Device Similar | Hypersensitivity Suspected Investigational Medical Device Similar
Item
any known/suspected allergies to trial medication or similar products/devices
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])
C2348205 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C2348205 (UMLS CUI [4,4])
C0020517 (UMLS CUI [5,1])
C2346570 (UMLS CUI [5,2])
C2348205 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C2346570 (UMLS CUI [6,3])
C2348205 (UMLS CUI [6,4])
Proliferative retinopathy | Disorder of macula of retina | Neuropathy Severe | Autonomic neuropathy
Item
a subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2])
C0442874 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0259749 (UMLS CUI [4])
Disease Clinical Significance
Item
clinically significant active disease of any kind
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Blood Donation Quantity
Item
blood donation (more than 500 ml) within the previous 9 weeks
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])