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Eligibility Diabetes Mellitus, Type 2 NCT02225691

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
hba1c ≥ 8% measured within the a month prior to enrolment
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
have not been performing smbg on a regular (daily) basis within the 3 months prior to enrolment
Description

Blood Glucose Self-Monitoring Regular Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0332197
willing and able to use accu-chek® active blood glucose meter to perform daily smbg
Description

Use of Accu-Chek Glucose Control Willing | Blood Glucose Self-Monitoring Daily Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0724912
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0005803
UMLS CUI [2,2]
C0332173
UMLS CUI [2,3]
C0600109
willing and able to complete participant questionnaires
Description

Questionnaires Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
willing and able to visit the physician at month 3 and month 6
Description

Physician Visits

Data type

boolean

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0545082
provide informed consent prior to enrolling in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any retinopathy that required photocoagulation or retinal surgery in the 6 months prior to enrolment or that may require photocoagulation or retinal surgery during the study
Description

Retinal Disease Requirement Light Coagulation | Retinal Disease Requirement Operation on retina

Data type

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0023694
UMLS CUI [2,1]
C0035309
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0197770
any clinically significant condition that required hospitalization in the last 2 months prior to enrolment or that may require hospitalization (e.g. elective surgery) during the study
Description

Medical condition Hospitalization Required | Elective Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1708385
UMLS CUI [2]
C0206058
any clinically significant psychosis or cognitive impairment
Description

Psychotic Disorders | Impaired cognition

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0338656
unlikelihood to comply or complete the study
Description

Compliance behavior Unlikely | Completion of clinical trial Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0750558
UMLS CUI [2,1]
C2732579
UMLS CUI [2,2]
C0750558
women who are pregnant, lactating or planning to become pregnant during the study period
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02225691

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus
Item
diagnosed with diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≥ 8% measured within the a month prior to enrolment
boolean
C0474680 (UMLS CUI [1])
Blood Glucose Self-Monitoring Regular Absent
Item
have not been performing smbg on a regular (daily) basis within the 3 months prior to enrolment
boolean
C0005803 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Use of Accu-Chek Glucose Control Willing | Blood Glucose Self-Monitoring Daily Willing
Item
willing and able to use accu-chek® active blood glucose meter to perform daily smbg
boolean
C1524063 (UMLS CUI [1,1])
C0724912 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0005803 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Questionnaires Completion
Item
willing and able to complete participant questionnaires
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Physician Visits
Item
willing and able to visit the physician at month 3 and month 6
boolean
C0031831 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Informed Consent
Item
provide informed consent prior to enrolling in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Retinal Disease Requirement Light Coagulation | Retinal Disease Requirement Operation on retina
Item
any retinopathy that required photocoagulation or retinal surgery in the 6 months prior to enrolment or that may require photocoagulation or retinal surgery during the study
boolean
C0035309 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0023694 (UMLS CUI [1,3])
C0035309 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0197770 (UMLS CUI [2,3])
Medical condition Hospitalization Required | Elective Surgical Procedures
Item
any clinically significant condition that required hospitalization in the last 2 months prior to enrolment or that may require hospitalization (e.g. elective surgery) during the study
boolean
C3843040 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
C0206058 (UMLS CUI [2])
Psychotic Disorders | Impaired cognition
Item
any clinically significant psychosis or cognitive impairment
boolean
C0033975 (UMLS CUI [1])
C0338656 (UMLS CUI [2])
Compliance behavior Unlikely | Completion of clinical trial Unlikely
Item
unlikelihood to comply or complete the study
boolean
C1321605 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C2732579 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, lactating or planning to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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