ID

29031

Description

A Study for Patients With Diabetes Mellitus (IOPA); ODM derived from: https://clinicaltrials.gov/show/NCT00420095

Link

https://clinicaltrials.gov/show/NCT00420095

Keywords

Versions (2)
  1. 2/21/18 2/21/18 -
  2. 2/21/18 2/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 21, 2018

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, Type 1 NCT00420095

English

Eligibility Diabetes Mellitus, Type 1 NCT00420095

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically diagnosed type 1or type 2 diabetes for at least 2 months
Description

Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
aged between 18 and 70 (inclusive)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study
Description

Insulin Mix | Insulin Dosage Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1720722
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0439603
have glycosylated hemoglobin (hb1ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at visit 1
Description

Glycosylated haemoglobin increased

Data type

boolean

Alias
UMLS CUI [1]
C0239940
compliance with diet and insulin therapy and performs regular blood glucose monitoring
Description

Compliance behavior Diet therapy | Compliance behavior Insulin regime | Blood Glucose Self-Monitoring Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0012159
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0557978
UMLS CUI [3,1]
C0005803
UMLS CUI [3,2]
C0205272
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have used oral antidiabetic agents within 30 days prior to entry into the study
Description

Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
receive a total daily dose of insulin >2 units/kilogram
Description

Insulin U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0456683
have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
Description

Hypoglycemia Severe Episode Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
have a body mass index >35 kilograms per square meter (kg/m2)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
receive chronic systemic glucocorticoid therapy
Description

Systemic Glucocorticoids chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C0205191
Back to the top of the page

Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00420095

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
clinically diagnosed type 1or type 2 diabetes for at least 2 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Age
Item
aged between 18 and 70 (inclusive)
boolean
C0001779 (UMLS CUI [1])
Insulin Mix | Insulin Dosage Frequency
Item
have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study
boolean
C0021641 (UMLS CUI [1,1])
C1720722 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2,3])
Glycosylated haemoglobin increased
Item
have glycosylated hemoglobin (hb1ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at visit 1
boolean
C0239940 (UMLS CUI [1])
Compliance behavior Diet therapy | Compliance behavior Insulin regime | Blood Glucose Self-Monitoring Regular
Item
compliance with diet and insulin therapy and performs regular blood glucose monitoring
boolean
C1321605 (UMLS CUI [1,1])
C0012159 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0005803 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral
Item
have used oral antidiabetic agents within 30 days prior to entry into the study
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Insulin U/day
Item
receive a total daily dose of insulin >2 units/kilogram
boolean
C0021641 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Hypoglycemia Severe Episode Quantity
Item
have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Body mass index
Item
have a body mass index >35 kilograms per square meter (kg/m2)
boolean
C1305855 (UMLS CUI [1])
Systemic Glucocorticoids chronic
Item
receive chronic systemic glucocorticoid therapy
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
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