age 1 Year to 6 Years
Item
age 1 Year to 6 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Pediatric patients with type 1 diabetes mellitus aged >= one year to < 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study
Item
Pediatric patients with type 1 diabetes mellitus aged >= one year to < 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study
boolean
C1521725 (UMLS CUI 2011AA)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1519316 (UMLS CUI 2011AA)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0030551 (UMLS CUI 2011AA)
40683002 (SNOMED CT 2011_0131)
PARNT (HL7 V3 2006_05)
C0023226 (UMLS CUI 2011AA)
58626002 (SNOMED CT 2011_0131)
MTHU020628 (LOINC Version 232)
Diagnosis of type 1 diabetes for < one year
Item
Diagnosis of type 1 diabetes for < one year
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
HbA1c at screening >12% or <6%
Item
HbA1c at screening >12% or <6%
boolean
C0019018 (UMLS CUI 2011AA)
Diabetes other than type 1 diabetes
Item
Diabetes other than type 1 diabetes
boolean
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
Item
Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
boolean
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C1276391 (UMLS CUI 2011AA)
359772000 (SNOMED CT 2011_0131)
C0785704 (UMLS CUI 2011AA)
354068006 (SNOMED CT 2011_0131)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C0586328 (UMLS CUI 2011AA)
308755006 (SNOMED CT 2011_0131)
Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
Item
Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
boolean
C1518422 (UMLS CUI 2011AA)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0872182 (UMLS CUI 2011AA)
C0449913 (UMLS CUI 2011AA)
246333005 (SNOMED CT 2011_0131)
MTHU025766 (LOINC Version 232)
C1511726 (UMLS CUI 2011AA)
Patients treated with insulin pump therapy during the two months prior to screening
Item
Patients treated with insulin pump therapy during the two months prior to screening
boolean
C1140609 (UMLS CUI 2011AA)
69805005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
History of primary seizure disorder
Item
History of primary seizure disorder
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0852425 (UMLS CUI 2011AA)
10039912 (MedDRA 14.1)
History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
Item
History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0009421 (UMLS CUI 2011AA)
371632003 (SNOMED CT 2011_0131)
10010071 (MedDRA 14.1)
MTHU020645 (LOINC Version 232)
R40.20 (ICD-10-CM Version 2010)
780.01 (ICD-9-CM Version 2011)
C0011880 (UMLS CUI 2011AA)
420422005 (SNOMED CT 2011_0131)
10012671 (MedDRA 14.1)
250.1 (ICD-9-CM Version 2011)
Need for chronic treatment with acetaminophen (paracetamol)-containing medications
Item
Need for chronic treatment with acetaminophen (paracetamol)-containing medications
boolean
C0686904 (UMLS CUI 2011AA)
103325001 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0000970 (UMLS CUI 2011AA)
387517004 (SNOMED CT 2011_0131)
MTHU003399 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
Serum creatinine > 2.0mg/dL at screening
Item
Serum creatinine > 2.0mg/dL at screening
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Serum ALT or AST > 3x upper limit of normal for the patient's age and gender, at screening
Item
Serum ALT or AST > 3x upper limit of normal for the patient's age and gender, at screening
boolean
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
Hemoglobin < 10g/dL, or platelet count < 100,000/cu mm, at screening
Item
Hemoglobin < 10g/dL, or platelet count < 100,000/cu mm, at screening
boolean
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C1409616 (UMLS CUI 2011AA)
Treatment with any pharmacologic anti-hyperglycemic oral agent for > 3 months at any time
Item
Treatment with any pharmacologic anti-hyperglycemic oral agent for > 3 months at any time
boolean
C0039798 (UMLS CUI 2011AA)
C0205464 (UMLS CUI 2011AA)
56183000 (SNOMED CT 2011_0131)
C0359086 (UMLS CUI 2011AA)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin) for the 3 months prior to screening
Item
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin) for the 3 months prior to screening
boolean
C0039798 (UMLS CUI 2011AA)
C2825234 (UMLS CUI 2011AA)
C1174780 (UMLS CUI 2011AA)
427360000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Treatment with systemic glucocorticoids within the month prior to screening
Item
Treatment with systemic glucocorticoids within the month prior to screening
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
CL428886 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)