ID

33155

Description

Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT01176149

Link

https://clinicaltrials.gov/show/NCT01176149

Keywords

Versions (1)
  1. 11/29/18 11/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 29, 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 Type 2 Diabetes NCT01176149

English

Eligibility Type 2 Diabetes NCT01176149

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
patients on treatment with oha monotherapy (i.e. metformin alone or sulphonylureas alone or tzds alone);
Description

Oral hypoglycemic | Metformin | Sulfonylureas | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0038766
UMLS CUI [4]
C1257987
no need for insulin treatment;
Description

Requirement Absent Insulin regime

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0557978
male and female patients, aged between 45-75 years;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
no experience of self monitoring of blood glucose in the previous 12 months (smbg performed with a frequency of < 1 times/week)
Description

Experience Absent Blood Glucose Self-Monitoring

Data type

boolean

Alias
UMLS CUI [1,1]
C0596545
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0005803
ability and willingness to comply with all study requirements
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
signature of consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients incapable to perform smbg
Description

Blood Glucose Self-Monitoring Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C1299582
patients needing insulin or multiple oha association therapy
Description

Patient need for Insulin | Patient need for Oral hypoglycemic Multiple therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021641
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0359086
UMLS CUI [2,3]
C3854359
patients needing a regular use of smbg (e.g. frequent hypoglycemic episodes)
Description

Patient need for Blood Glucose Self-Monitoring Regular | Hypoglycaemic episode Frequent

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0005803
UMLS CUI [1,3]
C0205272
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0332183
diabetes care not exclusively managed by diabetic clinics
Description

Diabetic care Did not attend diabetic clinic

Data type

boolean

Alias
UMLS CUI [1,1]
C0150544
UMLS CUI [1,2]
C1272080
patients with serious underlying medical or psychiatric condition
Description

Medical condition Serious | Mental condition Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0205404
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes NCT01176149

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
boolean
C0011860 (UMLS CUI [1])
Oral hypoglycemic | Metformin | Sulfonylureas | Thiazolidinediones
Item
patients on treatment with oha monotherapy (i.e. metformin alone or sulphonylureas alone or tzds alone);
boolean
C0359086 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
Requirement Absent Insulin regime
Item
no need for insulin treatment;
boolean
C1514873 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [1,3])
Age
Item
male and female patients, aged between 45-75 years;
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
boolean
C0474680 (UMLS CUI [1])
Experience Absent Blood Glucose Self-Monitoring
Item
no experience of self monitoring of blood glucose in the previous 12 months (smbg performed with a frequency of < 1 times/week)
boolean
C0596545 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005803 (UMLS CUI [1,3])
Protocol Compliance
Item
ability and willingness to comply with all study requirements
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
signature of consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Blood Glucose Self-Monitoring Unable
Item
patients incapable to perform smbg
boolean
C0005803 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Patient need for Insulin | Patient need for Oral hypoglycemic Multiple therapy
Item
patients needing insulin or multiple oha association therapy
boolean
C0686904 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0359086 (UMLS CUI [2,2])
C3854359 (UMLS CUI [2,3])
Patient need for Blood Glucose Self-Monitoring Regular | Hypoglycaemic episode Frequent
Item
patients needing a regular use of smbg (e.g. frequent hypoglycemic episodes)
boolean
C0686904 (UMLS CUI [1,1])
C0005803 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0745153 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
Diabetic care Did not attend diabetic clinic
Item
diabetes care not exclusively managed by diabetic clinics
boolean
C0150544 (UMLS CUI [1,1])
C1272080 (UMLS CUI [1,2])
Medical condition Serious | Mental condition Serious
Item
patients with serious underlying medical or psychiatric condition
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3840291 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
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