ID

5107

Description

ODM derived from http://clinicaltrials.gov/show/NCT01234727

Link

http://clinicaltrials.gov/show/NCT01234727

Keywords

Versions (2)
  1. 2/12/13 2/12/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01234727 Diabetes Mellitus

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 18 Years to 75 Years
Description

age 18 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subjects diagnosed with type 1 or type 2 diabetes mellitus
Description

Subjects diagnosed with type 1 or type 2 diabetes mellitus

Data type

boolean

Alias
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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
Patients with stable blood glucose in judgment of the investigator.
Description

Patients with stable blood glucose in judgment of the investigator.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0005802
Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)
Description

Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)

Data type

boolean

Alias
UMLS CUI 2011AA
C0522510
SNOMED CT 2011_0131
103370009
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
UMLS CUI 2011AA
C0332173
SNOMED CT 2011_0131
69620002
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
Patients perform blood glucose self measurements on a routine basis
Description

Patients perform blood glucose self measurements on a routine basis

Data type

boolean

Alias
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0005803
SNOMED CT 2011_0131
308113006
UMLS CUI 2011AA
C0205547
SNOMED CT 2011_0131
50811001
UMLS CUI 2011AA
C1527178
Patients must have experience in self measurement blood glucose for at least 6 months.
Description

Patients must have experience in self measurement blood glucose for at least 6 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0596545
UMLS CUI 2011AA
C0005803
SNOMED CT 2011_0131
308113006
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Exclusion Criteria
Description

Exclusion Criteria

Patients with unstable blood glucose in judgment of the investigator.
Description

Patients with unstable blood glucose in judgment of the investigator.

Data type

boolean

Alias
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0005802
Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.
Description

Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1335499
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0302523
UMLS CUI 2011AA
C1948053
Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.
Description

Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0457432
SNOMED CT 2011_0131
258143003
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2346608
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Subject without legal capacity.
Description

Subject without legal capacity.

Data type

boolean

Alias
UMLS CUI 2011AA
C1705492
UMLS CUI 2011AA
C0683673
Blood donation within the last 30 days.
Description

Blood donation within the last 30 days.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005794
SNOMED CT 2011_0131
25179006
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Pregnancy, Gestation
Description

Known pregnancy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Subject has already participated in the study.
Description

Subject has already participated in the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects diagnosed with type 1 or type 2 diabetes mellitus
Item
Subjects diagnosed with type 1 or type 2 diabetes mellitus
boolean
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)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
Patients with stable blood glucose in judgment of the investigator.
Item
Patients with stable blood glucose in judgment of the investigator.
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0005802 (UMLS CUI 2011AA)
Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)
Item
Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)
boolean
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
Patients perform blood glucose self measurements on a routine basis
Item
Patients perform blood glucose self measurements on a routine basis
boolean
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
C0205547 (UMLS CUI 2011AA)
50811001 (SNOMED CT 2011_0131)
C1527178 (UMLS CUI 2011AA)
Patients must have experience in self measurement blood glucose for at least 6 months.
Item
Patients must have experience in self measurement blood glucose for at least 6 months.
boolean
C0596545 (UMLS CUI 2011AA)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Item Group
Exclusion Criteria
Patients with unstable blood glucose in judgment of the investigator.
Item
Patients with unstable blood glucose in judgment of the investigator.
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0005802 (UMLS CUI 2011AA)
Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.
Item
Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1335499 (UMLS CUI 2011AA)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0302523 (UMLS CUI 2011AA)
C1948053 (UMLS CUI 2011AA)
Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.
Item
Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.
boolean
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2346608 (UMLS CUI 2011AA)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Subject without legal capacity.
Item
Subject without legal capacity.
boolean
C1705492 (UMLS CUI 2011AA)
C0683673 (UMLS CUI 2011AA)
Blood donation within the last 30 days.
Item
Blood donation within the last 30 days.
boolean
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Known pregnancy.
Item
Pregnancy, Gestation
boolean
C0549206 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Subject has already participated in the study.
Item
Subject has already participated in the study.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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