ID

25565

Beschrijving

GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets; ODM derived from: https://clinicaltrials.gov/show/NCT00499824

Link

https://clinicaltrials.gov/show/NCT00499824

Trefwoorden

Versies (1)
  1. 06-09-17 06-09-17 -
Geüploaded op

6 september 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00499824

Engels

Eligibility Type 2 Diabetes Mellitus NCT00499824

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women who are 30 to 75 years of age (inclusive) at study visit 1.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
clinical diagnosis of type 2 diabetes (defined according to idf guidelines) for a minimum of 6 months prior to study visit 1
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
patients for whom the gp is the primary medical provider of diabetes care and for whom referral to another doctor for diabetes care is not anticipated within 3 months of study visit 1
Beschrijving

Medical care Diabetes Mellitus General Practitioner

Datatype

boolean

Alias
UMLS CUI [1,1]
C0496675
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0017319
patients who give informed consent to participate.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria
Beschrijving

Exclusion Criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
patients with type 1 diabetes mellitus
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
patients with any previous episode of ketoacidosis
Beschrijving

Ketoacidosis Episode of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220982
UMLS CUI [1,2]
C0332189
patients who required chronic use (>/= 6 months) of insulin at any time in the past, with the exception of females during pregnancy
Beschrijving

Insulin use chronic Patient need for | Exception Gender Pregnancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0240016
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0079399
UMLS CUI [2,3]
C0032961
patients receiving insulin treatment at study visit 1 or within the previous 6 months, with the exception of patients who received short-term treatment (= 7 days) with insulin to maintain glycaemic control for an acute event (e.g. hospitalisation or medical procedure/intervention, infection or trauma).
Beschrijving

Insulin regime | Exception Insulin regime short-term | Maintenance Glycaemia control Event | Hospitalization | Medical procedure | Intervention | Communicable Disease | Trauma

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0557978
UMLS CUI [2,3]
C0443303
UMLS CUI [3,1]
C0024501
UMLS CUI [3,2]
C3267174
UMLS CUI [3,3]
C0441471
UMLS CUI [4]
C0019993
UMLS CUI [5]
C0199171
UMLS CUI [6]
C0184661
UMLS CUI [7]
C0009450
UMLS CUI [8]
C3714660
treatment with glucocorticoid at study visit 1 or within the previous 6 months, with the exception of topical or inhaled glucocorticoid
Beschrijving

Glucocorticoid therapy | Exception Topical glucocorticoid | Exception Glucocorticoids Inhaled

Datatype

boolean

Alias
UMLS CUI [1]
C0744425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017712
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0017710
UMLS CUI [3,3]
C0001559
females who are pregnant or considering pregnancy or stopping contraception within the course of the study
Beschrijving

Pregnancy | Pregnancy, Planned | Gender Contraceptive methods Discontinued

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1444662
patients with end-stage renal disease, defined as glomerular filtration rate (gfr) by the mdrd (modification of diet in renal disease) formula < 15 ml/min/1.73 m2, or on renal replacement therapy with haemodialysis, peritoneal dialysis or renal transplant.
Beschrijving

Kidney Failure, Chronic | Glomerular Filtration Rate MDRD formula | Renal Replacement Therapy | Hemodialysis | Peritoneal Dialysis | Kidney Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C0017654
UMLS CUI [2,2]
C3839656
UMLS CUI [3]
C0206074
UMLS CUI [4]
C0019004
UMLS CUI [5]
C0031139
UMLS CUI [6]
C0022671
patients with psychiatric disease, active drug or alcohol abuse or other cognitive impairment that may interfere with treatment compliance.
Beschrijving

Mental disorders | Substance Use Disorders | Impaired cognition Interferes with Treatment compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C0338656
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1321605
receipt of any investigational drug within 30 days of study visit 1.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
patients receiving diabetes care from another doctor (specialist endocrinologist, general physician, or another gp) other eligibility criteria considerations the hba1c at entry for newly recruited patients will be monitored centrally. if there is a significant risk that more than 25% of the total study population will have a baseline hba1c </= 6.5%, then recruitment of subsequent patients will be restricted to those with hba1c > 6.5%.
Beschrijving

Medical care Diabetes Mellitus Endocrinologist | Medical care Diabetes Mellitus General Practitioners | Clinical Trial Eligibility Criteria | Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1,1]
C0496675
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0259863
UMLS CUI [2,1]
C0496675
UMLS CUI [2,2]
C0011849
UMLS CUI [2,3]
C0017319
UMLS CUI [3]
C1516637
UMLS CUI [4]
C0019018
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00499824

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women who are 30 to 75 years of age (inclusive) at study visit 1.
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
clinical diagnosis of type 2 diabetes (defined according to idf guidelines) for a minimum of 6 months prior to study visit 1
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Medical care Diabetes Mellitus General Practitioner
Item
patients for whom the gp is the primary medical provider of diabetes care and for whom referral to another doctor for diabetes care is not anticipated within 3 months of study visit 1
boolean
C0496675 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0017319 (UMLS CUI [1,3])
Informed Consent
Item
patients who give informed consent to participate.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria
boolean
C0680251 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
patients with type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Ketoacidosis Episode of
Item
patients with any previous episode of ketoacidosis
boolean
C0220982 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
Insulin use chronic Patient need for | Exception Gender Pregnancy
Item
patients who required chronic use (>/= 6 months) of insulin at any time in the past, with the exception of females during pregnancy
boolean
C0240016 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0079399 (UMLS CUI [2,2])
C0032961 (UMLS CUI [2,3])
Insulin regime | Exception Insulin regime short-term | Maintenance Glycaemia control Event | Hospitalization | Medical procedure | Intervention | Communicable Disease | Trauma
Item
patients receiving insulin treatment at study visit 1 or within the previous 6 months, with the exception of patients who received short-term treatment (= 7 days) with insulin to maintain glycaemic control for an acute event (e.g. hospitalisation or medical procedure/intervention, infection or trauma).
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0024501 (UMLS CUI [3,1])
C3267174 (UMLS CUI [3,2])
C0441471 (UMLS CUI [3,3])
C0019993 (UMLS CUI [4])
C0199171 (UMLS CUI [5])
C0184661 (UMLS CUI [6])
C0009450 (UMLS CUI [7])
C3714660 (UMLS CUI [8])
Glucocorticoid therapy | Exception Topical glucocorticoid | Exception Glucocorticoids Inhaled
Item
treatment with glucocorticoid at study visit 1 or within the previous 6 months, with the exception of topical or inhaled glucocorticoid
boolean
C0744425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017712 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0017710 (UMLS CUI [3,2])
C0001559 (UMLS CUI [3,3])
Pregnancy | Pregnancy, Planned | Gender Contraceptive methods Discontinued
Item
females who are pregnant or considering pregnancy or stopping contraception within the course of the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
Kidney Failure, Chronic | Glomerular Filtration Rate MDRD formula | Renal Replacement Therapy | Hemodialysis | Peritoneal Dialysis | Kidney Transplantation
Item
patients with end-stage renal disease, defined as glomerular filtration rate (gfr) by the mdrd (modification of diet in renal disease) formula < 15 ml/min/1.73 m2, or on renal replacement therapy with haemodialysis, peritoneal dialysis or renal transplant.
boolean
C0022661 (UMLS CUI [1])
C0017654 (UMLS CUI [2,1])
C3839656 (UMLS CUI [2,2])
C0206074 (UMLS CUI [3])
C0019004 (UMLS CUI [4])
C0031139 (UMLS CUI [5])
C0022671 (UMLS CUI [6])
Mental disorders | Substance Use Disorders | Impaired cognition Interferes with Treatment compliance
Item
patients with psychiatric disease, active drug or alcohol abuse or other cognitive impairment that may interfere with treatment compliance.
boolean
C0004936 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0338656 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
Investigational New Drugs
Item
receipt of any investigational drug within 30 days of study visit 1.
boolean
C0013230 (UMLS CUI [1])
Medical care Diabetes Mellitus Endocrinologist | Medical care Diabetes Mellitus General Practitioners | Clinical Trial Eligibility Criteria | Glycosylated hemoglobin A
Item
patients receiving diabetes care from another doctor (specialist endocrinologist, general physician, or another gp) other eligibility criteria considerations the hba1c at entry for newly recruited patients will be monitored centrally. if there is a significant risk that more than 25% of the total study population will have a baseline hba1c </= 6.5%, then recruitment of subsequent patients will be restricted to those with hba1c > 6.5%.
boolean
C0496675 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0259863 (UMLS CUI [1,3])
C0496675 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0017319 (UMLS CUI [2,3])
C1516637 (UMLS CUI [3])
C0019018 (UMLS CUI [4])
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