Insulin-Dependent Diabetes Mellitus Disease length | Injection therapy
Item
type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0444472 (UMLS CUI [2])
Basal insulin | Insulin Glargine | insulin detemir | NPH insulin | Injection Quantity Daily | Mealtime Insulin injection Quantity Daily | Insulin Aspart | Insulin Lispro | Insulin Glulisine | Human Insulin | Bolus Insulin regime
Item
current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, nph insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
boolean
C0650607 (UMLS CUI [1])
C0907402 (UMLS CUI [2])
C0537270 (UMLS CUI [3])
C0021658 (UMLS CUI [4])
C1533685 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0332173 (UMLS CUI [5,3])
C0587119 (UMLS CUI [6,1])
C0199782 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C0332173 (UMLS CUI [6,4])
C1708521 (UMLS CUI [7])
C0293359 (UMLS CUI [8])
C1313386 (UMLS CUI [9])
C0795635 (UMLS CUI [10])
C0557978 (UMLS CUI [11,1])
C1705509 (UMLS CUI [11,2])
Hemoglobin A1c measurement Maximum
Item
hba1c maximum 10.0 % by central laboratory analysis
boolean
C0474680 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Insulin regime Self-Management | Insulin dose changed
Item
ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
boolean
C0557978 (UMLS CUI [1,1])
C0086969 (UMLS CUI [1,2])
C3875568 (UMLS CUI [2])
Protocol Compliance | Plasma Glucose Measurement Self | Insulin Dose Adjustment Self
Item
ability and willingness to adhere to the protocol including performance of self measured plasma glucose (smpg) profiles and self adjustment of insulin doses
boolean
C0525058 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0456081 (UMLS CUI [3,3])
C0036588 (UMLS CUI [3,4])
Hypoglycemic Agents | Exception Insulin
Item
use within the last 3 months prior to visit 1 of any antidiabetic glucose lowering drug other than insulin
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0581377 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0162577 (UMLS CUI [7])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure above or equal to 100 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms | History of cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0455471 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])