ID

39027

Beschrijving

Relationship Between HbA1c, Fasting Plasma Glucose, Post-prandial Glucose and Other Measures of Glycemic Control; ODM derived from: https://clinicaltrials.gov/show/NCT02117154

Link

https://clinicaltrials.gov/show/NCT02117154

Trefwoorden

Versies (1)
  1. 22-11-19 22-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02117154

Engels

Eligibility Diabetes Mellitus, Type 2 NCT02117154

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with t2dm with stable hba1c
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | HbA1c Stable

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0019018
UMLS CUI [2,2]
C0205360
on oad, insulin or combination therapy for a minimum of 3 months
Beschrijving

Antidiabetics Oral | Insulin | Combined Modality Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0009429
hba1c ≥ 6%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
estimated glomerular filtration rate (egfr) ≥ 60 ml/min
Beschrijving

Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C3811844
normal haemoglobin level male: 13.0 - 18.0 g/dl female: 11.5 - 16.5 g/dl mean corpuscular volume (mcv): 77 - 95 femtoliters (fl) mean corpuscular hemoglobin (mch): 27 - 32 pg mean corpuscular hemoglobin concentration (mchc): 32 - 36 g/dl
Beschrijving

Hemoglobin measurement | Gender | Mean Corpuscular Volume | Mean Corpuscular Hemoglobin | Mean corpuscular hemoglobin concentration

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0524587
UMLS CUI [4]
C1261502
UMLS CUI [5]
C0474535
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
newly diagnosed t2dm (<3 months)
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Newly Diagnosed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1518321
t1dm patients
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
not on oad or insulin therapy
Beschrijving

Oral Antidiabetics Absent | Insulin regime Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0332197
hospitalized patients
Beschrijving

Hospitalized patients

Datatype

boolean

Alias
UMLS CUI [1]
C0870668
patients with other co-morbidities, eg chronic liver disease, advanced cardiac disease, malignancy, on steroid therapy
Beschrijving

Comorbidity | Chronic liver disease | Heart Disease Advanced | Malignant Neoplasms | Steroid therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0341439
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205179
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0149783
egfr< 60ml /min
Beschrijving

Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C3811844
patients with anaemia
Beschrijving

Anemia

Datatype

boolean

Alias
UMLS CUI [1]
C0002871
known haemoglobinopathies, eg alpha and beta thalassemia, sickle cell disease, hemoglobin-e thalassemia etc
Beschrijving

Hemoglobinopathies | alpha-Thalassemia | beta Thalassemia | Anemia, Sickle Cell | Haemoglobin E-thalassaemia

Datatype

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0002312
UMLS CUI [3]
C0005283
UMLS CUI [4]
C0002895
UMLS CUI [5]
C1328338
patients with history of blood transfusion in the preceding three months
Beschrijving

Blood Transfusion Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0332185
patients who are likely to receive or donate blood / blood products during the study period
Beschrijving

Patients Receiving Blood | Patients Receiving Blood product | Blood Donation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0005767
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0456388
UMLS CUI [3]
C0005794
patients who are on erythropoietin therapy
Beschrijving

Erythropoietin therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0199970
patients who are pregnant or plan for pregnancy
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02117154

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | HbA1c Stable
Item
diagnosed with t2dm with stable hba1c
boolean
C0011860 (UMLS CUI [1])
C0019018 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Antidiabetics Oral | Insulin | Combined Modality Therapy
Item
on oad, insulin or combination therapy for a minimum of 3 months
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
hba1c ≥ 6%
boolean
C0474680 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate (egfr) ≥ 60 ml/min
boolean
C3811844 (UMLS CUI [1])
Hemoglobin measurement | Gender | Mean Corpuscular Volume | Mean Corpuscular Hemoglobin | Mean corpuscular hemoglobin concentration
Item
normal haemoglobin level male: 13.0 - 18.0 g/dl female: 11.5 - 16.5 g/dl mean corpuscular volume (mcv): 77 - 95 femtoliters (fl) mean corpuscular hemoglobin (mch): 27 - 32 pg mean corpuscular hemoglobin concentration (mchc): 32 - 36 g/dl
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0524587 (UMLS CUI [3])
C1261502 (UMLS CUI [4])
C0474535 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Newly Diagnosed
Item
newly diagnosed t2dm (<3 months)
boolean
C0011860 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
t1dm patients
boolean
C0011854 (UMLS CUI [1])
Oral Antidiabetics Absent | Insulin regime Absent
Item
not on oad or insulin therapy
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0557978 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hospitalized patients
Item
hospitalized patients
boolean
C0870668 (UMLS CUI [1])
Comorbidity | Chronic liver disease | Heart Disease Advanced | Malignant Neoplasms | Steroid therapy
Item
patients with other co-morbidities, eg chronic liver disease, advanced cardiac disease, malignancy, on steroid therapy
boolean
C0009488 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4])
C0149783 (UMLS CUI [5])
Estimated Glomerular Filtration Rate
Item
egfr< 60ml /min
boolean
C3811844 (UMLS CUI [1])
Anemia
Item
patients with anaemia
boolean
C0002871 (UMLS CUI [1])
Hemoglobinopathies | alpha-Thalassemia | beta Thalassemia | Anemia, Sickle Cell | Haemoglobin E-thalassaemia
Item
known haemoglobinopathies, eg alpha and beta thalassemia, sickle cell disease, hemoglobin-e thalassemia etc
boolean
C0019045 (UMLS CUI [1])
C0002312 (UMLS CUI [2])
C0005283 (UMLS CUI [3])
C0002895 (UMLS CUI [4])
C1328338 (UMLS CUI [5])
Blood Transfusion Recent
Item
patients with history of blood transfusion in the preceding three months
boolean
C0005841 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Patients Receiving Blood | Patients Receiving Blood product | Blood Donation
Item
patients who are likely to receive or donate blood / blood products during the study period
boolean
C0030705 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0456388 (UMLS CUI [2,3])
C0005794 (UMLS CUI [3])
Erythropoietin therapy
Item
patients who are on erythropoietin therapy
boolean
C0199970 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
patients who are pregnant or plan for pregnancy
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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