Informed Consent | Assent Child | Informed Consent Parent | Informed Consent Patient Representative | Assent Child Parent | Assent Child Patient Representative
Item
informed consent, and child assent as age-appropriate, obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject). the parents or legal representative of the child must sign and date the informed consent form according to local requirements. the child, if possible, parents or legal representative of the child must sign and date the child assent form according to local requirements
boolean
C0021430 (UMLS CUI [1])
C1879749 (UMLS CUI [2,1])
C0008059 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
C1879749 (UMLS CUI [5,1])
C0008059 (UMLS CUI [5,2])
C0030551 (UMLS CUI [5,3])
C1879749 (UMLS CUI [6,1])
C0008059 (UMLS CUI [6,2])
C0030701 (UMLS CUI [6,3])
Diabetes Mellitus, Insulin-Dependent
Item
male or female diagnosed with type 1 diabetes mellitus (t1dm) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
boolean
C0011854 (UMLS CUI [1])
Insulin regime | Antidiabetics Oral Absent
Item
ongoing daily treatment with insulin (any regimen) for at least 3 months prior to visit 1 (screening). no oads (oral anti-diabetic drugs) are allowed
boolean
C0557978 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) maximum 11%
boolean
C0474680 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Study Subject Participation Status
Item
previous participation in this trial. participation is defined as randomisation
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy intended
Item
girls who are pregnant, breastfeeding or intend to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
Menarche Contraceptive methods Absent
Item
girls who have had menarche and are not using adequate contraceptive measures according to local requirements
boolean
C0025274 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Loss of hypoglycemic warning | Hypoglycaemic episode Severe Recurrent
Item
known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator (trial physician)
boolean
C0342317 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])
Diabetic Ketoacidosis Quantity | Hospitalization Required
Item
more than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to visit 1
boolean
C0011880 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1708385 (UMLS CUI [2])
Comorbidity Interferes with Clinical Trial | Exception Condition Associated with Insulin-Dependent Diabetes Mellitus
Item
significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion could interfere with the trial
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0011854 (UMLS CUI [2,4])
Investigational New Drugs
Item
the receipt of any investigational drug within 1 month prior to visit 1
boolean
C0013230 (UMLS CUI [1])