ID

20590

Description

Semi-automatic Response System(SARS)in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01058733

Link

https://clinicaltrials.gov/show/NCT01058733

Keywords

Versions (1)
  1. 3/5/17 3/5/17 -
Uploaded on

March 5, 2017

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 NCT01058733

English

Eligibility Diabetes Mellitus NCT01058733

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women aged 20-70 years with type 2 diabetes
Description

Age | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
lasting more than one year who had used the online communication system for diabetes management at the web site https://www.bi odang.com for more than six months
Description

Diabetes mellitus management Communication System Web Site

Data type

boolean

Alias
UMLS CUI [1,1]
C0948092
UMLS CUI [1,2]
C0868936
UMLS CUI [1,3]
C2349146
baseline hba1c level was 6-10%
Description

Glycosylated hemoglobin A Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
patients who able and willing to complete glucose-monitoring diaries on a web chart as instructed.
Description

Glucose measurement by monitoring device Web Site Patient Diary Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0202048
UMLS CUI [1,2]
C2349146
UMLS CUI [1,3]
C3890583
UMLS CUI [1,4]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who required intensive insulin therapy (multiple insulin injections or insulin pump therapy) or who were unwilling to use self-monitoring of blood glucose (smbg)
Description

Insulin regime Patient need for | Administration of insulin multiple | Insulin pump Therapeutic procedure | Blood Glucose Self-Monitoring Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0439064
UMLS CUI [3,1]
C1140609
UMLS CUI [3,2]
C0087111
UMLS CUI [4,1]
C0005803
UMLS CUI [4,2]
C0558080
acute metabolic complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar non-ketotic hyperglycaemia, lactic acidosis)
Description

metabolic complications Diabetes Mellitus | Diabetic Ketoacidosis | NON-KETOTIC HYPEROSMOLAR HYPERGLYCEMIA | Acidosis, Lactic

Data type

boolean

Alias
UMLS CUI [1,1]
C1393263
UMLS CUI [1,2]
C0011849
UMLS CUI [2]
C0011880
UMLS CUI [3]
C0242019
UMLS CUI [4]
C0001125
serum creatinine concentration >2.0 mg/dl at screening
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
active liver disease or alt or ast activities >2.5 times the upper limit of normal
Description

Liver diseases | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
acute illness, chronic infection, heart failure of nyha class iii or iv
Description

Illness | Chronic infectious disease | Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0151317
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
recent myocardial infarction or stroke during the past six months
Description

Myocardial Infarction | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
pregnancy or gdm, or any other factor likely to limit protocol compliance or reporting of adverse events
Description

Pregnancy | Gestational Diabetes | Factor Protocol Compliance Limited | Reporting Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0085207
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0700287
UMLS CUI [4,2]
C0877248
Back to the top of the page

Similar models

Eligibility Diabetes Mellitus NCT01058733

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent
Item
men or women aged 20-70 years with type 2 diabetes
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Diabetes mellitus management Communication System Web Site
Item
lasting more than one year who had used the online communication system for diabetes management at the web site https://www.bi odang.com for more than six months
boolean
C0948092 (UMLS CUI [1,1])
C0868936 (UMLS CUI [1,2])
C2349146 (UMLS CUI [1,3])
Glycosylated hemoglobin A Percentage
Item
baseline hba1c level was 6-10%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Glucose measurement by monitoring device Web Site Patient Diary Completion
Item
patients who able and willing to complete glucose-monitoring diaries on a web chart as instructed.
boolean
C0202048 (UMLS CUI [1,1])
C2349146 (UMLS CUI [1,2])
C3890583 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Insulin regime Patient need for | Administration of insulin multiple | Insulin pump Therapeutic procedure | Blood Glucose Self-Monitoring Unwilling
Item
patients who required intensive insulin therapy (multiple insulin injections or insulin pump therapy) or who were unwilling to use self-monitoring of blood glucose (smbg)
boolean
C0557978 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0199782 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C1140609 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0005803 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
metabolic complications Diabetes Mellitus | Diabetic Ketoacidosis | NON-KETOTIC HYPEROSMOLAR HYPERGLYCEMIA | Acidosis, Lactic
Item
acute metabolic complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar non-ketotic hyperglycaemia, lactic acidosis)
boolean
C1393263 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0011880 (UMLS CUI [2])
C0242019 (UMLS CUI [3])
C0001125 (UMLS CUI [4])
Creatinine measurement, serum
Item
serum creatinine concentration >2.0 mg/dl at screening
boolean
C0201976 (UMLS CUI [1])
Liver diseases | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
active liver disease or alt or ast activities >2.5 times the upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Illness | Chronic infectious disease | Heart failure New York Heart Association Classification
Item
acute illness, chronic infection, heart failure of nyha class iii or iv
boolean
C0221423 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
Myocardial Infarction | Cerebrovascular accident
Item
recent myocardial infarction or stroke during the past six months
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Pregnancy | Gestational Diabetes | Factor Protocol Compliance Limited | Reporting Adverse event
Item
pregnancy or gdm, or any other factor likely to limit protocol compliance or reporting of adverse events
boolean
C0032961 (UMLS CUI [1])
C0085207 (UMLS CUI [2])
C1521761 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0700287 (UMLS CUI [4,1])
C0877248 (UMLS CUI [4,2])
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