ID
44639
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT01134107
Link
http://clinicaltrials.gov/show/NCT01134107
Stichworte
Versionen (4)
- 06.12.13 06.12.13 - Martin Dugas
- 06.12.13 06.12.13 - Martin Dugas
- 17.04.14 17.04.14 - Julian Varghese
- 27.09.21 27.09.21 -
Hochgeladen am
27. September 2021
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility NCT01134107 Diabetes Mellitus, Type 1
Eligibility
- StudyEvent: Eligibility
Beschreibung
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschreibung
Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study
Datentyp
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
Beschreibung
Impaired renal function (serum creatinine >= 2.0 mg/dl)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1565489
- SNOMED CT 2011_0131
- 236423003
- MedDRA 14.1
- 10062237
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Beschreibung
Legal blindness
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0271215
- SNOMED CT 2011_0131
- 65956007
Beschreibung
Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation
Datentyp
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
Beschreibung
Have had hypoglycemia unawareness (routinely asymptomatic at BG < 45 mg/dl) in the 12 months prior to screening.
Datentyp
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
Beschreibung
Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
Datentyp
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
Beschreibung
Have had a pump-related infusion site abscess in the 12 months prior to screening.
Datentyp
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
Beschreibung
Have had multiple, clinically significant occlusions as judged by the investigator.
Datentyp
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
Beschreibung
Have had any infection with Staph aureus in the past 5 years
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1318973
- SNOMED CT 2011_0131
- 406602003
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.
Datentyp
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
Beschreibung
Have an irregular sleep/wake cycle in the investigator's opinion.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1862910
Beschreibung
Have a known hypersensitivity or allergy to any of the study insulins or their excipients
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
Datentyp
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
Ähnliche Modelle
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C0549178 (UMLS CUI 2011AA)
C0586328 (UMLS CUI 2011AA)
308755006 (SNOMED CT 2011_0131)
255586005 (SNOMED CT 2011_0131)
C2348070 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C1519795 (UMLS CUI 2011AA)
C1289877 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
15240007 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0549178 (UMLS CUI 2011AA)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
65956007 (SNOMED CT 2011_0131)
272128006 (SNOMED CT 2011_0131)
C0020617 (UMLS CUI 2011AA)
267384006 (SNOMED CT 2011_0131)
10021000 (MedDRA 14.1)
E15 (ICD-10-CM Version 2010)
251.0 (ICD-9-CM Version 2011)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0233407 (UMLS CUI 2011AA)
62476001 (SNOMED CT 2011_0131)
10013395 (MedDRA 14.1)
MTHU013516 (LOINC Version 232)
R41.0 (ICD-10-CM Version 2010)
10020997 (MedDRA 14.1)
C0205547 (UMLS CUI 2011AA)
50811001 (SNOMED CT 2011_0131)
C0231221 (UMLS CUI 2011AA)
84387000 (SNOMED CT 2011_0131)
C0005802 (UMLS CUI 2011AA)
ER (HL7 V3 2006_05)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C0726398 (UMLS CUI 2011AA)
44668000 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C1142012 (UMLS CUI 2011AA)
10058464 (MedDRA 14.1)
255204007 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
CL354751 (UMLS CUI 2011AA)
26036001 (SNOMED CT 2011_0131)
10029990 (MedDRA 14.1)
406602003 (SNOMED CT 2011_0131)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C2242489 (UMLS CUI 2011AA)
10067777 (MedDRA 14.1)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
116859006 (SNOMED CT 2011_0131)
10005835 (MedDRA 14.1)
MTHU020992 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C0019045 (UMLS CUI 2011AA)
80141007 (SNOMED CT 2011_0131)
10060892 (MedDRA 14.1)
MTHU029621 (LOINC Version 232)
D58.2 (ICD-10-CM Version 2010)
C0002878 (UMLS CUI 2011AA)
61261009 (SNOMED CT 2011_0131)
10018916 (MedDRA 14.1)
D55-D59 (ICD-10-CM Version 2010)
C0002895 (UMLS CUI 2011AA)
127040003 (SNOMED CT 2011_0131)
10040641 (MedDRA 14.1)
MTHU021603 (LOINC Version 232)
D57.1 (ICD-10-CM Version 2010)
282.6 (ICD-9-CM Version 2011)
C0349705 (UMLS CUI 2011AA)
10018879 (MedDRA 14.1)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0969625 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
CL428886 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
10006247 (MedDRA 14.1)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C1096117 (UMLS CUI 2011AA)
10053762 (MedDRA 14.1)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0010995 (UMLS CUI 2011AA)
C0699733 (UMLS CUI 2011AA)
49062001 (SNOMED CT 2011_0131)
MTHU020022 (LOINC Version 232)