ID

35718

Description

Abbott Sensor Based Glucose Monitoring System Paediatric Study; ODM derived from: https://clinicaltrials.gov/show/NCT02388815

Link

https://clinicaltrials.gov/show/NCT02388815

Keywords

Versions (1)
  1. 3/18/19 3/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 18, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes Mellitus NCT02388815

English

Eligibility Diabetes Mellitus NCT02388815

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 4 years, ≤17 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
each participant has an identified caregiver of ≥18 years
Description

Caregiver | Age

Data type

boolean

Alias
UMLS CUI [1]
C0085537
UMLS CUI [2]
C0001779
type 1 or type 2 diabetes using insulin administered by injections or csii
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Administration of insulin | Continuous subcutaneous infusion of insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0199782
UMLS CUI [4]
C0393124
currently testing blood glucose, on average at least 2 times per day
Description

Blood glucose measurement times/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0392201
UMLS CUI [1,2]
C0439511
in the investigator's opinion, technically capable of using device (participant and/or caregiver).
Description

Study Subject Using device | Caregiver Using device

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1828349
UMLS CUI [2,1]
C0085537
UMLS CUI [2,2]
C1828349
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition
Description

Comorbidity compromises Patient safety | Cystic Fibrosis | Mental Disorders, Severe | Eating Disorder | Eating Disorder Suspected | Medical condition Long-term Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2]
C0010674
UMLS CUI [3]
C4046029
UMLS CUI [4]
C0013473
UMLS CUI [5,1]
C0013473
UMLS CUI [5,2]
C0750491
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0443252
UMLS CUI [6,3]
C0205318
currently prescribed oral steroid therapy for any acute or chronic condition
Description

Oral steroid therapy Medical condition | Oral steroid therapy Chronic condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0574135
UMLS CUI [1,2]
C3843040
UMLS CUI [2,1]
C0574135
UMLS CUI [2,2]
C4315615
currently receiving dialysis treatment or planning to receive dialysis during the study
Description

Dialysis | Dialysis Planned

Data type

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C1301732
female participant known to be pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management
Description

Study Subject Participation Status | Glucose monitoring device Affecting Glucose measurement | Investigational New Drugs Affecting Glucose measurement | Glucose monitoring device Affecting Blood glucose management | Investigational New Drugs Affecting Blood glucose management

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0202048
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0337438
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0337438
UMLS CUI [4,1]
C0202048
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1638311
UMLS CUI [5,1]
C0013230
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1638311
currently using a continuous glucose monitoring (cgm) device
Description

Continuous glucose monitoring Device

Data type

boolean

Alias
UMLS CUI [1,1]
C4523945
UMLS CUI [1,2]
C0025080
known (or suspected) allergy to medical grade adhesives
Description

Hypersensitivity MEDICAL ADHESIVE | Hypersensitivity Suspected MEDICAL ADHESIVE

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0726995
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0726995
in the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered)
Description

Study Subject Participation Status Inappropriate | Caregiver Inappropriate Participation Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0085537
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0679823
UMLS CUI [2,4]
C0008976
Back to the top of the page

Similar models

Eligibility Diabetes Mellitus NCT02388815

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 4 years, ≤17 years
boolean
C0001779 (UMLS CUI [1])
Caregiver | Age
Item
each participant has an identified caregiver of ≥18 years
boolean
C0085537 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Administration of insulin | Continuous subcutaneous infusion of insulin
Item
type 1 or type 2 diabetes using insulin administered by injections or csii
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0199782 (UMLS CUI [3])
C0393124 (UMLS CUI [4])
Blood glucose measurement times/day
Item
currently testing blood glucose, on average at least 2 times per day
boolean
C0392201 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
Study Subject Using device | Caregiver Using device
Item
in the investigator's opinion, technically capable of using device (participant and/or caregiver).
boolean
C0681850 (UMLS CUI [1,1])
C1828349 (UMLS CUI [1,2])
C0085537 (UMLS CUI [2,1])
C1828349 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Comorbidity compromises Patient safety | Cystic Fibrosis | Mental Disorders, Severe | Eating Disorder | Eating Disorder Suspected | Medical condition Long-term Uncontrolled
Item
concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition
boolean
C0009488 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0010674 (UMLS CUI [2])
C4046029 (UMLS CUI [3])
C0013473 (UMLS CUI [4])
C0013473 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C3843040 (UMLS CUI [6,1])
C0443252 (UMLS CUI [6,2])
C0205318 (UMLS CUI [6,3])
Oral steroid therapy Medical condition | Oral steroid therapy Chronic condition
Item
currently prescribed oral steroid therapy for any acute or chronic condition
boolean
C0574135 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0574135 (UMLS CUI [2,1])
C4315615 (UMLS CUI [2,2])
Dialysis | Dialysis Planned
Item
currently receiving dialysis treatment or planning to receive dialysis during the study
boolean
C0011946 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Pregnancy
Item
female participant known to be pregnant
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status | Glucose monitoring device Affecting Glucose measurement | Investigational New Drugs Affecting Glucose measurement | Glucose monitoring device Affecting Blood glucose management | Investigational New Drugs Affecting Blood glucose management
Item
participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management
boolean
C2348568 (UMLS CUI [1])
C0202048 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0337438 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0337438 (UMLS CUI [3,3])
C0202048 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1638311 (UMLS CUI [4,3])
C0013230 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1638311 (UMLS CUI [5,3])
Continuous glucose monitoring Device
Item
currently using a continuous glucose monitoring (cgm) device
boolean
C4523945 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
Hypersensitivity MEDICAL ADHESIVE | Hypersensitivity Suspected MEDICAL ADHESIVE
Item
known (or suspected) allergy to medical grade adhesives
boolean
C0020517 (UMLS CUI [1,1])
C0726995 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0726995 (UMLS CUI [2,3])
Study Subject Participation Status Inappropriate | Caregiver Inappropriate Participation Clinical Trial
Item
in the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered)
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0085537 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial