Informed Consent
Item
informed consent obtained before any study-related activities. (study-related activities are any procedures related to recording of data according to the protocol)
boolean
C0021430 (UMLS CUI [1])
Consent Patient data Matching | Sick Fund Data
Item
patients willing and able to give signed consent on matching patient data with sick fund data
boolean
C1511481 (UMLS CUI [1,1])
C2707520 (UMLS CUI [1,2])
C1708943 (UMLS CUI [1,3])
C1411275 (UMLS CUI [2,1])
C0016820 (UMLS CUI [2,2])
C1511726 (UMLS CUI [2,3])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Patient need for Intensification therapy | Insulin | liraglutide | Victoza | Etiology Blood Glucose Poorly controlled
Item
patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (victoza®) due to inadequate blood glucose control
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C1511484 (UMLS CUI [3,2])
C0021641 (UMLS CUI [4])
C1456408 (UMLS CUI [5])
C2732208 (UMLS CUI [6])
C0015127 (UMLS CUI [7,1])
C0005802 (UMLS CUI [7,2])
C3853134 (UMLS CUI [7,3])
Membership Sick Fund
Item
patient is a member of the involved sick fund (aok plus)
boolean
C0680038 (UMLS CUI [1,1])
C1411275 (UMLS CUI [1,2])
C0016820 (UMLS CUI [1,3])
Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs
Item
known or suspected contra-indication to the relevant study product according to current spc
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Study Subject Participation Status
Item
previous participation in this study
boolean
C2348568 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin regime Previous | Exception Emergency treatment
Item
previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days)
boolean
C0557978 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013969 (UMLS CUI [2,2])
Prior Therapy Liraglutide
Item
previous treatment with liraglutide
boolean
C1514463 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
Gastroparesis due to diabetes mellitus | Precoma Diabetic | Diabetic Ketoacidosis
Item
history of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis
boolean
C0267176 (UMLS CUI [1])
C1142529 (UMLS CUI [2,1])
C0241863 (UMLS CUI [2,2])
C0011880 (UMLS CUI [3])
Progressive Disease Fatal
Item
progressive fatal disease
boolean
C1335499 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
Study Subject Participation Status Excluded | Compliance behavior Lacking | Patient safety Concern | Substance Use Disorders
Item
any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse
boolean
C2348568 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1113679 (UMLS CUI [3,1])
C2699424 (UMLS CUI [3,2])
C0038586 (UMLS CUI [4])
Legal capacity Lacking
Item
patients without legal capacity
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])