ID
44639
Description
ODM derived from http://clinicaltrials.gov/show/NCT01134107
Link
http://clinicaltrials.gov/show/NCT01134107
Keywords
Versions (4)
- 12/6/13 12/6/13 - Martin Dugas
- 12/6/13 12/6/13 - Martin Dugas
- 4/17/14 4/17/14 - Julian Varghese
- 9/27/21 9/27/21 -
Uploaded on
September 27, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01134107 Diabetes Mellitus, Type 1
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0549178
- UMLS CUI 2011AA
- C0005803
- SNOMED CT 2011_0131
- 308113006
Description
Impaired renal function (serum creatinine >= 2.0 mg/dl)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1565489
- SNOMED CT 2011_0131
- 236423003
- MedDRA 14.1
- 10062237
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Description
Legal blindness
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0271215
- SNOMED CT 2011_0131
- 65956007
Description
Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332189
- SNOMED CT 2011_0131
- 272128006
- UMLS CUI 2011AA
- C0020617
- SNOMED CT 2011_0131
- 267384006
- MedDRA 14.1
- 10021000
- ICD-10-CM Version 2010
- E15
- ICD-9-CM Version 2011
- 251.0
- UMLS CUI 2011AA
- C0036572
- SNOMED CT 2011_0131
- 91175000
- MedDRA 14.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
- UMLS CUI 2011AA
- C0233407
- SNOMED CT 2011_0131
- 62476001
- MedDRA 14.1
- 10013395
- LOINC Version 232
- MTHU013516
- ICD-10-CM Version 2010
- R41.0
Description
Have had hypoglycemia unawareness (routinely asymptomatic at BG < 45 mg/dl) in the 12 months prior to screening.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0342317
- MedDRA 14.1
- 10020997
- UMLS CUI 2011AA
- C0205547
- SNOMED CT 2011_0131
- 50811001
- UMLS CUI 2011AA
- C0231221
- SNOMED CT 2011_0131
- 84387000
- UMLS CUI 2011AA
- C0005802
Description
Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1546435
- HL7 V3 2006_05
- ER
- UMLS CUI 2011AA
- C1512346
- HL7 V3 2006_05
- ENC
- UMLS CUI 2011AA
- C0019993
- SNOMED CT 2011_0131
- 394656005
- MedDRA 14.1
- 10054112
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C0205169
- SNOMED CT 2011_0131
- 556001
- UMLS CUI 2011AA
- C0726398
Description
Have had a pump-related infusion site abscess in the 12 months prior to screening.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0182537
- SNOMED CT 2011_0131
- 44668000
- UMLS CUI 2011AA
- C0699792
- SNOMED CT 2011_0131
- 263498003
- UMLS CUI 2011AA
- C1142012
- MedDRA 14.1
- 10058464
Description
Have had multiple, clinically significant occlusions as judged by the investigator.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0439064
- SNOMED CT 2011_0131
- 255204007
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- CL354751
- SNOMED CT 2011_0131
- 26036001
- MedDRA 14.1
- 10029990
Description
Have had any infection with Staph aureus in the past 5 years
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1318973
- SNOMED CT 2011_0131
- 406602003
Description
Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0243087
- UMLS CUI 2011AA
- C0018939
- SNOMED CT 2011_0131
- 191124002
- MedDRA 14.1
- 10061590
- ICD-10-CM Version 2010
- D75.9
- ICD-9-CM Version 2011
- 289.9
- UMLS CUI 2011AA
- C2242489
- MedDRA 14.1
- 10067777
- UMLS CUI 2011AA
- C0022658
- SNOMED CT 2011_0131
- 90708001
- MedDRA 14.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- UMLS CUI 2011AA
- C0023895
- SNOMED CT 2011_0131
- 235856003
- MedDRA 14.1
- 10024670
- ICD-10-CM Version 2010
- K76.9
- ICD-9-CM Version 2011
- 573.9
- UMLS CUI 2011AA
- C0017178
- SNOMED CT 2011_0131
- 119292006
- MedDRA 14.1
- 10017944
Description
Patients with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
Description
Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0005841
- SNOMED CT 2011_0131
- 116859006
- MedDRA 14.1
- 10005835
- LOINC Version 232
- MTHU020992
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0019080
- SNOMED CT 2011_0131
- 50960005
- MedDRA 14.1
- 10055798
- ICD-10-CM Version 2010
- R58
- ICD-9-CM Version 2011
- 459.0
- UMLS CUI 2011AA
- C0019045
- SNOMED CT 2011_0131
- 80141007
- MedDRA 14.1
- 10060892
- LOINC Version 232
- MTHU029621
- ICD-10-CM Version 2010
- D58.2
- UMLS CUI 2011AA
- C0002878
- SNOMED CT 2011_0131
- 61261009
- MedDRA 14.1
- 10018916
- ICD-10-CM Version 2010
- D55-D59
- UMLS CUI 2011AA
- C0002895
- SNOMED CT 2011_0131
- 127040003
- MedDRA 14.1
- 10040641
- LOINC Version 232
- MTHU021603
- ICD-10-CM Version 2010
- D57.1
- ICD-9-CM Version 2011
- 282.6
- UMLS CUI 2011AA
- C0349705
- MedDRA 14.1
- 10018879
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0019018
- SNOMED CT 2011_0131
- 33601001
- LOINC Version 232
- MTHU018890
- UMLS CUI 2011AA
- C0969625
Description
Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- CL428886
- MedDRA 14.1
- 10071104
Description
Have an irregular sleep/wake cycle in the investigator's opinion.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1862910
Description
Have a known hypersensitivity or allergy to any of the study insulins or their excipients
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 257550005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0021641
- SNOMED CT 2011_0131
- 67866001
- LOINC Version 232
- MTHU019392
- UMLS CUI 2011AA
- C0015237
- SNOMED CT 2011_0131
- 360215002
Description
Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0032992
- SNOMED CT 2011_0131
- 169565003
- UMLS CUI 2011AA
- C0241028
- SNOMED CT 2011_0131
- 228453005
- MedDRA 14.1
- 10066098
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0420844
- SNOMED CT 2011_0131
- 169450001
Description
Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1516879
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
- UMLS CUI 2011AA
- C1096117
- MedDRA 14.1
- 10053762
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C2346570
Description
Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0457432
- SNOMED CT 2011_0131
- 258143003
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0010995
- UMLS CUI 2011AA
- C0699733
- SNOMED CT 2011_0131
- 49062001
- LOINC Version 232
- MTHU020022
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10028997 (MedDRA 14.1)
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