Informed Consent
Item
informed consent obtained
boolean
C0021430 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus for 12 months or longer
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal Bolus | Continuous subcutaneous infusion of insulin | Insulin pump
Item
basal bolus or csii (continuous subcutaneous insulin infusion, insulin pump) treatment for 6 months or longer
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 for the last 3 months prior to screening, as judged and documented by the investigator
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-10% (diabetes control and complications trial (dcct)), both inclusive, (corresponding to 53-86 mmol/mol (international federation of clinical chemistry (ifcc))
boolean
C0474680 (UMLS CUI [1])
Protocol Compliance | Questionnaire Completion | Subject Diary | Plasma Glucose Measurement Self Monitoring | Insulin Titration Self
Item
ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits
boolean
C0525058 (UMLS CUI [1])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C3890583 (UMLS CUI [3])
C0202042 (UMLS CUI [4,1])
C0588436 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5,1])
C0162621 (UMLS CUI [5,2])
C0036588 (UMLS CUI [5,3])
GLP-1 Receptor Agonist | Dipeptidyl Peptidase 4 Inhibitors
Item
prior use of glucagon-like peptide-1 (glp-1) receptor agonist or dipeptidyl peptidase iv (dpp-4) inhibitors
boolean
C2917359 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
Pharmaceutical Preparation Interferes with Glycaemia control | Pharmaceutical Preparations Affecting Patient safety | Premixed insulin
Item
use of any medication, which in the investigator's opinion could interfere with the glycaemic control 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])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C2069057 (UMLS CUI [3])
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])
Blood Pressure Uncontrolled | Blood Pressure Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled/ untreated blood pressure at screening above 160 mmhg for systolic or above 100 mmhg for diastolic
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Pancreatitis | Pancreatitis, Chronic
Item
history of acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value equal to or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (men2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])