ID

38645

Descrição

Continuous Glucose Monitoring Self-Monitored Blood Glucose Type 2 Therapy Matrix Definition; ODM derived from: https://clinicaltrials.gov/show/NCT01390610

Link

https://clinicaltrials.gov/show/NCT01390610

Palavras-chave

Versões (1)
  1. 29/10/2019 29/10/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

29 de outubro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01390610

Inglês

Eligibility Diabetes Mellitus, Type 2 NCT01390610

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
diagnosed with type 2 diabetes and treated with diabetes medication(s) as required by the protocol (see section 3.1)
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Protocol Required

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C1514873
age 18 and older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
willing to give informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
motivated and capable of following the protocol and instructions provided by the healthcare professional
Descrição

Adherence Study Protocol | Adherence Instructions Research Personnel

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C1442085
UMLS CUI [2,3]
C0035173
available for the study on the scheduled visit days
Descrição

Patient Available Clinical Trial | Patient Available Clinic Visits

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C0008952
have not participated in a prior research trial at idc that utilized cgm
Descrição

Participation Absent Clinical Trial Continuous glucose monitoring

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C4523945
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
under 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
skin abnormalities at the cgm insertion sites that would confound assessment of the effect of the device on the skin
Descrição

Skin Abnormalities Continuous glucose monitoring Site

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037268
UMLS CUI [1,2]
C4523945
UMLS CUI [1,3]
C1515974
allergy to adhesives
Descrição

Allergy to adhesive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1635164
taken prednisone or cortisone medications in the previous 30 days
Descrição

Prednisone | Cortisone

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032952
UMLS CUI [2]
C0010137
currently pregnant or planning pregnancy during the study period
Descrição

Pregnancy | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the subject's safety or successful participation in the study
Descrição

Medical condition Severe compromises Patient safety | Mental condition Severe compromises Patient safety | Chronic condition compromises Patient safety | Chronic infectious disease compromises Patient safety | Medical condition Severe compromises Study Subject Participation Status | Mental condition Severe compromises Study Subject Participation Status | Chronic condition compromises Study Subject Participation Status | Chronic infectious disease compromises Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C4315615
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0151317
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C1113679
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C2945640
UMLS CUI [5,4]
C2348568
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C2945640
UMLS CUI [6,4]
C2348568
UMLS CUI [7,1]
C4315615
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C2348568
UMLS CUI [8,1]
C0151317
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C2348568
unable to follow the study protocol
Descrição

Protocol Compliance Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
unable to speak, read and write in english
Descrição

Lacking Able to speak English Language | Lacking Able to read English Language | Lacking Able to write English Language

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0586740
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0584993
UMLS CUI [3,3]
C0376245
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01390610

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Protocol Required
Item
diagnosed with type 2 diabetes and treated with diabetes medication(s) as required by the protocol (see section 3.1)
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Age
Item
age 18 and older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing to give informed consent
boolean
C0021430 (UMLS CUI [1])
Adherence Study Protocol | Adherence Instructions Research Personnel
Item
motivated and capable of following the protocol and instructions provided by the healthcare professional
boolean
C1510802 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1510802 (UMLS CUI [2,1])
C1442085 (UMLS CUI [2,2])
C0035173 (UMLS CUI [2,3])
Patient Available Clinical Trial | Patient Available Clinic Visits
Item
available for the study on the scheduled visit days
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0008952 (UMLS CUI [2,3])
Participation Absent Clinical Trial Continuous glucose monitoring
Item
have not participated in a prior research trial at idc that utilized cgm
boolean
C0679823 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C4523945 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Age
Item
under 18 years of age
boolean
C0001779 (UMLS CUI [1])
Skin Abnormalities Continuous glucose monitoring Site
Item
skin abnormalities at the cgm insertion sites that would confound assessment of the effect of the device on the skin
boolean
C0037268 (UMLS CUI [1,1])
C4523945 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Allergy to adhesive
Item
allergy to adhesives
boolean
C1635164 (UMLS CUI [1])
Prednisone | Cortisone
Item
taken prednisone or cortisone medications in the previous 30 days
boolean
C0032952 (UMLS CUI [1])
C0010137 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned
Item
currently pregnant or planning pregnancy during the study period
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Medical condition Severe compromises Patient safety | Mental condition Severe compromises Patient safety | Chronic condition compromises Patient safety | Chronic infectious disease compromises Patient safety | Medical condition Severe compromises Study Subject Participation Status | Mental condition Severe compromises Study Subject Participation Status | Chronic condition compromises Study Subject Participation Status | Chronic infectious disease compromises Study Subject Participation Status
Item
presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the subject's safety or successful participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C4315615 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0151317 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C2945640 (UMLS CUI [5,3])
C2348568 (UMLS CUI [5,4])
C3840291 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C2945640 (UMLS CUI [6,3])
C2348568 (UMLS CUI [6,4])
C4315615 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0151317 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
Protocol Compliance Unable
Item
unable to follow the study protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Lacking Able to speak English Language | Lacking Able to read English Language | Lacking Able to write English Language
Item
unable to speak, read and write in english
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0586740 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C0584993 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
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