Informed Consent
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female, aged equal to or greater than 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to visit 1 (i.e. screening)
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Bolus | Continuous subcutaneous infusion of insulin | Insulin pump
Item
treatment with basal bolus or csii (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to visit 1 (i.e. screening)
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0393124 (UMLS CUI [2])
C1140609 (UMLS CUI [3])
Insulin regime Stable
Item
stable insulin treatment 3 months or longer prior to visit 1 (i.e. screening), as judged and documented by the investigator
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Hemoglobin A1c measurement | HbA1c measurement (DCCT aligned)
Item
hba1c 7.0-10.0 percent (diabetes control and complications trial (dcct)), both inclusive, by central laboratory analysis (visit 1, screening) corresponding to 53-86 mmol/mol (international federation of clinical chemistry (ifcc))
boolean
C0474680 (UMLS CUI [1])
C1277712 (UMLS CUI [2])
GLP-1 Receptor Agonist | Dipeptidyl Peptidase 4 Inhibitors
Item
prior use of glucagon-like peptide-1 (glp-1) receptor agonist or dipeptidyl peptidase iv (dppiv) inhibitors
boolean
C2917359 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
Pharmaceutical Preparations Interfere Glycaemia control | CORTICOSTEROIDS FOR SYSTEMIC USE | Pramlintide | Symlin | Pharmaceutical Preparations Affecting Patient safety | Premixed insulin
Item
use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (symlin®)) or affect the subject's safety. premix insulin is not allowed
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3267174 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2])
C0537551 (UMLS CUI [3])
C1174780 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C2069057 (UMLS CUI [6])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Neuropathy Severe | Autonomic neuropathy | Gastroparesis
Item
severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
boolean
C0442874 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0259749 (UMLS CUI [2])
C0152020 (UMLS CUI [3])
Sitting systolic blood pressure Uncontrolled | Sitting diastolic blood pressure Uncontrolled | Sitting systolic blood pressure Untreated | Sitting diastolic blood pressure Untreated | Status post Rest Number of minutes
Item
uncontrolled/untreated blood pressure at screening (visit 1) (after resting for 5 minutes) while sitting greater than 160 mmhg for systolic or greater than 100 mmhg for diastolic (repeated measurement at visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)
boolean
C1319893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C1319894 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0035253 (UMLS CUI [5,2])
C1562039 (UMLS CUI [5,3])
Pancreatitis | Pancreatitis, Chronic
Item
history of acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Calcitonin measurement
Item
screening (visit 1) calcitonin value equal to or greater than 50 ng/l
boolean
C0201924 (UMLS CUI [1])