informed consent
Item
informed consent obtained before any study-related activities. (study-related activities are any procedures that are related to recording of data according to the protocol). the historical data including the data before informed consent obtained (e.g., hba1c (glycated haemoglobin ), fpg (fasting plasma glucose), pppg (postprandial plasma glucose), severe hypoglycaemia before the start of ryzodeg therapy) can be used for baseline data
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent; ryzodeg
Item
patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with ryzodeg™ based on the clinical judgment of their treating physician
boolean
C0011854 (UMLS CUI [1])
C3661220 (UMLS CUI [2])
allergy; ryzodeg
Item
known or suspected allergy to ryzodeg™ any of the active substances or any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C3661220 (UMLS CUI [1,2])
participation status
Item
previous participation in this study
boolean
C2348568 (UMLS CUI [1])
Clinical Research; Disruption
Item
mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
boolean
C0008972 (UMLS CUI [1])
C0332453 (UMLS CUI [2])
therapy; ryzodeg
Item
patients who are or have previously been on ryzodeg™ therapy
boolean
C0087111 (UMLS CUI [1])
C3661220 (UMLS CUI [2])
clinical trials other
Item
patients who are participating in other studies or clinical trials
boolean
C2348568 (UMLS CUI [1])
pregnant; breast feeding
Item
patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])