ID
5064
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00993473
Link
http://clinicaltrials.gov/show/NCT00993473
Trefwoorden
Versies (2)
- 07-12-13 07-12-13 - Martin Dugas
- 17-04-14 17-04-14 - Julian Varghese
Geüploaded op
17 april 2014
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Eligibility NCT00993473 Type 1 Diabetes Mellitus
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
Diagnosis of type 1 diabetes for < one year
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
- UMLS CUI 2011AA
- C0011854
- SNOMED CT 2011_0131
- 46635009
- MedDRA 14.1
- 10067584
- LOINC Version 232
- MTHU020217
- ICD-10-CM Version 2010
- E10
- UMLS CUI 2011AA
- C0439092
- SNOMED CT 2011_0131
- 276139006
- HL7 V3 2006_05
- LT
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
Beschrijving
HbA1c at screening >12% or <6%
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0019018
Beschrijving
Diabetes other than type 1 diabetes
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0011849
- SNOMED CT 2011_0131
- 191044006
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0011854
- SNOMED CT 2011_0131
- 46635009
- MedDRA 14.1
- 10067584
- LOINC Version 232
- MTHU020217
- ICD-10-CM Version 2010
- E10
Beschrijving
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)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0558080
- SNOMED CT 2011_0131
- 225465005
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 405078008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C1276391
- SNOMED CT 2011_0131
- 359772000
- UMLS CUI 2011AA
- C0785704
- SNOMED CT 2011_0131
- 354068006
- UMLS CUI 2011AA
- C0439064
- SNOMED CT 2011_0131
- 255204007
- UMLS CUI 2011AA
- C0332173
- SNOMED CT 2011_0131
- 69620002
- UMLS CUI 2011AA
- C0586328
- SNOMED CT 2011_0131
- 308755006
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1301820
- SNOMED CT 2011_0131
- 398092000
- UMLS CUI 2011AA
- C0205452
- SNOMED CT 2011_0131
- 68244004
- UMLS CUI 2011AA
- C0439228
- SNOMED CT 2011_0131
- 258703001
- HL7 V3 2006_05
- D
- UMLS CUI 2011AA
- C0205197
- SNOMED CT 2011_0131
- 255594003
- UMLS CUI 2011AA
- C0872182
- UMLS CUI 2011AA
- C0449913
- SNOMED CT 2011_0131
- 246333005
- LOINC Version 232
- MTHU025766
- UMLS CUI 2011AA
- C1511726
Beschrijving
Patients treated with insulin pump therapy during the two months prior to screening
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1140609
- SNOMED CT 2011_0131
- 69805005
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Beschrijving
History of primary seizure disorder
Datatype
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- CL414904
- UMLS CUI 2011AA
- C0852425
- MedDRA 14.1
- 10039912
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0020615
- SNOMED CT 2011_0131
- 302866003
- MedDRA 14.1
- 10020993
- ICD-10-CM Version 2010
- E16.2
- ICD-9-CM Version 2011
- 251.2
- CTCAE 1105E
- E12322
- UMLS CUI 2011AA
- C0332189
- SNOMED CT 2011_0131
- 272128006
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
- UMLS CUI 2011AA
- C0009421
- SNOMED CT 2011_0131
- 371632003
- MedDRA 14.1
- 10010071
- LOINC Version 232
- MTHU020645
- ICD-10-CM Version 2010
- R40.20
- ICD-9-CM Version 2011
- 780.01
- UMLS CUI 2011AA
- C0011880
- SNOMED CT 2011_0131
- 420422005
- MedDRA 14.1
- 10012671
- ICD-9-CM Version 2011
- 250.1
Beschrijving
Need for chronic treatment with acetaminophen (paracetamol)-containing medications
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0686904
- SNOMED CT 2011_0131
- 103325001
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0000970
- SNOMED CT 2011_0131
- 387517004
- LOINC Version 232
- MTHU003399
- UMLS CUI 2011AA
- C0332256
- SNOMED CT 2011_0131
- 42504009
- UMLS CUI 2011AA
- C0013227
Beschrijving
Serum creatinine > 2.0mg/dL at screening
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C1409616
Beschrijving
Serum ALT or AST > 3x upper limit of normal for the patient's age and gender, at screening
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- C1409616
Beschrijving
Hemoglobin < 10g/dL, or platelet count < 100,000/cu mm, at screening
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0019046
- SNOMED CT 2011_0131
- 38082009
- MedDRA 14.1
- 10019481
- LOINC Version 232
- LP14449-0
- UMLS CUI 2011AA
- C1287267
- SNOMED CT 2011_0131
- 365632008
- LOINC Version 232
- 777-3
- UMLS CUI 2011AA
- C1409616
Beschrijving
Treatment with any pharmacologic anti-hyperglycemic oral agent for > 3 months at any time
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205464
- SNOMED CT 2011_0131
- 56183000
- UMLS CUI 2011AA
- C0359086
- SNOMED CT 2011_0131
- 346597008
- LOINC Version 232
- MTHU003326
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205449
- SNOMED CT 2011_0131
- 421291004
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Beschrijving
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin) for the 3 months prior to screening
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C2825234
- UMLS CUI 2011AA
- C1174780
- SNOMED CT 2011_0131
- 427360000
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
Beschrijving
Treatment with systemic glucocorticoids within the month prior to screening
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- CL428886
- MedDRA 14.1
- 10071104
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
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- StudyEvent: Eligibility
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