ID

38943

Description

Comparing the Effect of Structured Care Versus Usual Care in Type 2 Diabetes Patients Across the Asia Pacific Region; ODM derived from: https://clinicaltrials.gov/show/NCT01631084

Link

https://clinicaltrials.gov/show/NCT01631084

Keywords

Versions (1)
  1. 11/14/19 11/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01631084

English

Eligibility Diabetes NCT01631084

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01631084
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetic patients who are willing or can be persuaded to return for 'regular'
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
follow-up at 3-4 monthly intervals
Description

Follow-up Time Interval Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0872291
UMLS CUI [1,3]
C0600109
patients with newly diagnosed or established disease, treated with lifestyle modification or blood glucose lowering drugs including oral agents with or without insulin
Description

Disease Newly Diagnosed | Disease Established | Lifestyle change therapy | Hypoglycemic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443211
UMLS CUI [3]
C2960841
UMLS CUI [4]
C0020616
for newly diagnosed type 2 diabetic patients, their plasma glucose levels should be:
Description

Non-Insulin-Dependent Diabetes Mellitus Newly Diagnosed | Plasma glucose level Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0455280
UMLS CUI [2,2]
C1514873
fasting plasma glucose (pg) >7.0 mmol/l on 2 or more occasions, and/or
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
random or 2-hour pg >11.1 mmol/l (after 75 gram oral glucose tolerance test) on 2 or more occasions, and/or
Description

Plasma random glucose measurement | Status post Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1]
C0583512
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0029161
hba1c >6.5%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis
Description

Diabetes Mellitus, Insulin-Dependent | Ketosis | Symptoms Ketonuria Severe | Ketoacidosis | Requirement Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0022638
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0162275
UMLS CUI [3,3]
C0205082
UMLS CUI [4]
C0220982
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0021641
patients with reduced life expectancy (e.g. less than 6 months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life-threatening conditions
Description

Reduced life expectancy | Advanced cancer | Condition Life Threatening

Data type

boolean

Alias
UMLS CUI [1]
C1858274
UMLS CUI [2]
C0877373
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2826244
patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
Description

Study Protocol Comprehension Unable | Etiology Mental condition

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C3840291
patients actively enrolled in another intervention study
Description

Study Subject Participation Status | Interventional Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
patients who are unwilling to return for regular follow up.
Description

Follow-up Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Diabetes NCT01631084

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01631084
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetic patients who are willing or can be persuaded to return for 'regular'
boolean
C0011860 (UMLS CUI [1])
Follow-up Time Interval Willing
Item
follow-up at 3-4 monthly intervals
boolean
C3274571 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Disease Newly Diagnosed | Disease Established | Lifestyle change therapy | Hypoglycemic Agents
Item
patients with newly diagnosed or established disease, treated with lifestyle modification or blood glucose lowering drugs including oral agents with or without insulin
boolean
C0012634 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443211 (UMLS CUI [2,2])
C2960841 (UMLS CUI [3])
C0020616 (UMLS CUI [4])
Non-Insulin-Dependent Diabetes Mellitus Newly Diagnosed | Plasma glucose level Required
Item
for newly diagnosed type 2 diabetic patients, their plasma glucose levels should be:
boolean
C0011860 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0455280 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose (pg) >7.0 mmol/l on 2 or more occasions, and/or
boolean
C0583513 (UMLS CUI [1])
Plasma random glucose measurement | Status post Oral Glucose Tolerance Test
Item
random or 2-hour pg >11.1 mmol/l (after 75 gram oral glucose tolerance test) on 2 or more occasions, and/or
boolean
C0583512 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0029161 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
hba1c >6.5%
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketosis | Symptoms Ketonuria Severe | Ketoacidosis | Requirement Insulin
Item
type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis
boolean
C0011854 (UMLS CUI [1])
C0022638 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0162275 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0220982 (UMLS CUI [4])
C1514873 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
Reduced life expectancy | Advanced cancer | Condition Life Threatening
Item
patients with reduced life expectancy (e.g. less than 6 months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life-threatening conditions
boolean
C1858274 (UMLS CUI [1])
C0877373 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
Study Protocol Comprehension Unable | Etiology Mental condition
Item
patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C3840291 (UMLS CUI [2,2])
Study Subject Participation Status | Interventional Study
Item
patients actively enrolled in another intervention study
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
Follow-up Unwilling
Item
patients who are unwilling to return for regular follow up.
boolean
C3274571 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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