ID

37404

Beschrijving

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

Trefwoorden

  1. 23-07-19 23-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 juli 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT02485132

Eligibility Type 2 Diabetes NCT02485132

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

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

Gliclazide | Gliclazide MR

Datatype

boolean

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

Metformin Stable

Datatype

boolean

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

Hemoglobin A1c measurement

Datatype

boolean

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

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Hypoglycemic Agents | Exception Metformin

Datatype

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
Beschrijving

Pharmaceutical Preparation Interferes with Glucose metabolism

Datatype

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
Beschrijving

Patient need for Insulin | Catabolic state | Ketonuria

Datatype

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
Beschrijving

Continuous glucose monitoring system

Datatype

boolean

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

Hypoglycemia Severe

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

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
Beschrijving

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

Datatype

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)
Datatype
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])

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