ID

38983

Beschrijving

RetroMASTER - Retrospective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02109978

Link

https://clinicaltrials.gov/show/NCT02109978

Trefwoorden

Versies (1)
  1. 17-11-19 17-11-19 -
Houder van rechten

See clinicaltrials.gov

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17 november 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT02109978

Engels

Eligibility Diabetes NCT02109978

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02109978
Criteria
Beschrijving

Criteria

demographics: age 18-90 inclusive
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ethnicity: reflective of local demographic
Beschrijving

Ethnicity | Demographic Factor Local

Datatype

boolean

Alias
UMLS CUI [1]
C0015031
UMLS CUI [2,1]
C0011292
UMLS CUI [2,2]
C0205276
medical history: clinical diagnosis of type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
mental capacity: capacity to consent
Beschrijving

Legal capacity Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C1511481
responders cohort inclusion criteria:
Beschrijving

Therapy responder Cohort Inclusion criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C0919876
UMLS CUI [1,2]
C0599755
UMLS CUI [1,3]
C1512693
on sulphonylurea, dpp-4 inhibitor, glp-1r agonist, sglt2 inhibitor or glitazone for > 4 months.
Beschrijving

Sulfonylurea | Dipeptidyl Peptidase 4 Inhibitors | GLP-1 Receptor Agonist | SGLT2 Inhibitor | Thiazolidinediones

Datatype

boolean

Alias
UMLS CUI [1]
C0038766
UMLS CUI [2]
C2917254
UMLS CUI [3]
C2917359
UMLS CUI [4]
C3273807
UMLS CUI [5]
C1257987
pre-treatment hba1c≥ 58mmol/mol (7.5%).
Beschrijving

Pretreatment Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C3539075
UMLS CUI [1,2]
C0474680
progressors cohort inclusion criteria:
Beschrijving

Other Coding

Datatype

boolean

Alias
UMLS CUI [1]
C3846158
type 2 diabetes (not on insulin treatment within 6 months of diagnosis)
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Insulin regime Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0332197
either: requirement for insulin treatment ≤10 years from diagnosis (defined as insulin treatment or hba1c ≥ 69mmol/mol (8/5%) treated with two or more non-insulin diabetes therapies) or: no requirement for insulin treatment >10 years from diagnosis (defined as not on insulin treatment and hba1c <69mmol/mol (8.5%).
Beschrijving

Requirement Insulin regime | Hemoglobin A1c measurement | Diabetes Therapy Quantity | Exception Insulin | Insulin regime Absent | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0557978
UMLS CUI [2]
C0474680
UMLS CUI [3,1]
C3274787
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0021641
UMLS CUI [5,1]
C0557978
UMLS CUI [5,2]
C0332197
UMLS CUI [6]
C0474680
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
age less than 18 years old and greater than 90 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
incapacity to consent
Beschrijving

Legal capacity Consent Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C1511481
UMLS CUI [1,3]
C0332268
type 1 diabetes.
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
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Similar models

Eligibility Diabetes NCT02109978

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02109978
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Age
Item
demographics: age 18-90 inclusive
boolean
C0001779 (UMLS CUI [1])
Ethnicity | Demographic Factor Local
Item
ethnicity: reflective of local demographic
boolean
C0015031 (UMLS CUI [1])
C0011292 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
medical history: clinical diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Legal capacity Consent
Item
mental capacity: capacity to consent
boolean
C0683673 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
Therapy responder Cohort Inclusion criteria
Item
responders cohort inclusion criteria:
boolean
C0919876 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Sulfonylurea | Dipeptidyl Peptidase 4 Inhibitors | GLP-1 Receptor Agonist | SGLT2 Inhibitor | Thiazolidinediones
Item
on sulphonylurea, dpp-4 inhibitor, glp-1r agonist, sglt2 inhibitor or glitazone for > 4 months.
boolean
C0038766 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
C2917359 (UMLS CUI [3])
C3273807 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
Pretreatment Hemoglobin A1c measurement
Item
pre-treatment hba1c≥ 58mmol/mol (7.5%).
boolean
C3539075 (UMLS CUI [1,1])
C0474680 (UMLS CUI [1,2])
Other Coding
Item
progressors cohort inclusion criteria:
boolean
C3846158 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Insulin regime Absent
Item
type 2 diabetes (not on insulin treatment within 6 months of diagnosis)
boolean
C0011860 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Requirement Insulin regime | Hemoglobin A1c measurement | Diabetes Therapy Quantity | Exception Insulin | Insulin regime Absent | Hemoglobin A1c measurement
Item
either: requirement for insulin treatment ≤10 years from diagnosis (defined as insulin treatment or hba1c ≥ 69mmol/mol (8/5%) treated with two or more non-insulin diabetes therapies) or: no requirement for insulin treatment >10 years from diagnosis (defined as not on insulin treatment and hba1c <69mmol/mol (8.5%).
boolean
C1514873 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
C3274787 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])
C0557978 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0474680 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Age
Item
age less than 18 years old and greater than 90 years old
boolean
C0001779 (UMLS CUI [1])
Legal capacity Consent Lacking
Item
incapacity to consent
boolean
C0683673 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes.
boolean
C0011854 (UMLS CUI [1])
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