ID

37404

Description

Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea; ODM derived from: https://clinicaltrials.gov/show/NCT02485132

Link

https://clinicaltrials.gov/show/NCT02485132

Keywords

  1. 7/23/19 7/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 23, 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.

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 NCT02485132

Eligibility Type 2 Diabetes NCT02485132

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes according to canadian diabetes association definition
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
initiation of gliclazide or gliclazide mr at baseline
Description

Gliclazide | Gliclazide MR

Data type

boolean

Alias
UMLS CUI [1]
C0017631
UMLS CUI [2,1]
C0017631
UMLS CUI [2,2]
C1709058
currently treated with stable metformin monotherapy (≥3 months)
Description

Metformin Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0205360
a1c: 7.0% to 10.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
willing and able to comply with study procedures
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or previous usage of any other type of antihyperglycemic medication except metformin
Description

Hypoglycemic Agents | Exception Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
use of medication known to interfere with glucose metabolism
Description

Pharmaceutical Preparation Interferes with Glucose metabolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
insulin requiring patient: catabolic state and/or ketonuria
Description

Patient need for Insulin | Catabolic state | Ketonuria

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021641
UMLS CUI [2]
C0853892
UMLS CUI [3]
C0162275
currently using cgms or within the last 3 months
Description

Continuous glucose monitoring system

Data type

boolean

Alias
UMLS CUI [1,1]
C4523945
UMLS CUI [1,2]
C3888058
recent severe hypoglycemia (<3 months)
Description

Hypoglycemia Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
pregnancy or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
limited life expectancy, high level of functional dependency, extensive coronary disease at high risk of short term ischemic events or multiple major co-morbidities
Description

Life Expectancy Limited | High Level Functional dependency | Coronary disease Extensive | At risk for acute ischemic cardiac event | High risk of Comorbidities major multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C4321237
UMLS CUI [2,2]
C1268609
UMLS CUI [3,1]
C0010068
UMLS CUI [3,2]
C0205231
UMLS CUI [4]
C1443393
UMLS CUI [5,1]
C0332167
UMLS CUI [5,2]
C0009488
UMLS CUI [5,3]
C0205164
UMLS CUI [5,4]
C0439064

Similar models

Eligibility Type 2 Diabetes NCT02485132

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes according to canadian diabetes association definition
boolean
C0011860 (UMLS CUI [1])
Gliclazide | Gliclazide MR
Item
initiation of gliclazide or gliclazide mr at baseline
boolean
C0017631 (UMLS CUI [1])
C0017631 (UMLS CUI [2,1])
C1709058 (UMLS CUI [2,2])
Metformin Stable
Item
currently treated with stable metformin monotherapy (≥3 months)
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
a1c: 7.0% to 10.0%
boolean
C0474680 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with study procedures
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypoglycemic Agents | Exception Metformin
Item
current or previous usage of any other type of antihyperglycemic medication except metformin
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Pharmaceutical Preparation Interferes with Glucose metabolism
Item
use of medication known to interfere with glucose metabolism
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
Patient need for Insulin | Catabolic state | Ketonuria
Item
insulin requiring patient: catabolic state and/or ketonuria
boolean
C0686904 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0853892 (UMLS CUI [2])
C0162275 (UMLS CUI [3])
Continuous glucose monitoring system
Item
currently using cgms or within the last 3 months
boolean
C4523945 (UMLS CUI [1,1])
C3888058 (UMLS CUI [1,2])
Hypoglycemia Severe
Item
recent severe hypoglycemia (<3 months)
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life Expectancy Limited | High Level Functional dependency | Coronary disease Extensive | At risk for acute ischemic cardiac event | High risk of Comorbidities major multiple
Item
limited life expectancy, high level of functional dependency, extensive coronary disease at high risk of short term ischemic events or multiple major co-morbidities
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C4321237 (UMLS CUI [2,1])
C1268609 (UMLS CUI [2,2])
C0010068 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
C1443393 (UMLS CUI [4])
C0332167 (UMLS CUI [5,1])
C0009488 (UMLS CUI [5,2])
C0205164 (UMLS CUI [5,3])
C0439064 (UMLS CUI [5,4])

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

Fields marked with * are required.

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