Blood Glucose criteria Fulfill
Item
blood glucose criteria must be met
boolean
C0005802 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Insulin Dose Stable
Item
on a stable dose of insulin as defined by the protocol
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Body mass index
Item
body mass inde (bmi) in the range 22-45
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Complications of Diabetes Mellitus Serious Evidence of
Item
evidence of serious diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
Cardiac complication Serious Evidence of
Item
evidence of serious cardiovascular complications
boolean
C0161816 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
Laboratory test result abnormal
Item
laboratory value abnormalities as defined by the protocol
boolean
C0438215 (UMLS CUI [1])
Exclusion Criteria Study Protocol
Item
other protocol defined exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])