ID

39337

Description

A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM; ODM derived from: https://clinicaltrials.gov/show/NCT02176681

Link

https://clinicaltrials.gov/show/NCT02176681

Keywords

Versions (1)
  1. 12/22/19 12/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Haemodialyzed, Type 2 Diabetes NCT02176681

English

Eligibility Haemodialyzed, Type 2 Diabetes NCT02176681

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients treated by haemodialysis for more than 3 months with 1g/l glucose in dialysate fluid
Description

Hemodialysis | Glucose measurement Dialysis Solution

Data type

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2,1]
C0337438
UMLS CUI [2,2]
C0011947
patients treated by stable doses of insulin (any regimen) for type 2 diabetes without any oral antidiabetic agent
Description

Insulin Dose Stable | Insulin regime Any Non-Insulin-Dependent Diabetes Mellitus | Antidiabetics Oral Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C1552551
UMLS CUI [2,3]
C0011860
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0332197
age > 18 and < 83 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hba1c > 7%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
variability in epo doses > 20% of doses (u/kg/month) or blood transfusion in the 2 previous months
Description

Erythropoietin Dose Variability | Blood Transfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0014822
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2827666
UMLS CUI [2]
C0005841
patients suffering from stage 3 and 4 cardiac insufficiency
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
life expectancy less than 1 year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
chronic inflammatory disease
Description

Chronic inflammatory disorder

Data type

boolean

Alias
UMLS CUI [1]
C1290886
steroid treatment
Description

Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
cancer (evolutive or requiring chemotherapy or radiotherapy)
Description

Malignant Neoplasm Developmental | Malignant Neoplasm Requirement Chemotherapy | Malignant Neoplasm Requirement Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0458003
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0392920
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C1522449
patient waiting for programmed surgery
Description

Patient scheduled for surgery

Data type

boolean

Alias
UMLS CUI [1]
C3242215
history of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months
Description

Cardiovascular Disease | Cerebrovascular accident | Coronary heart disease | Hospitalization Due to Heart Failure

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0010068
UMLS CUI [4]
C3898876
non-compliant patients
Description

Patient Non-Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0376405
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Similar models

Eligibility Haemodialyzed, Type 2 Diabetes NCT02176681

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hemodialysis | Glucose measurement Dialysis Solution
Item
patients treated by haemodialysis for more than 3 months with 1g/l glucose in dialysate fluid
boolean
C0019004 (UMLS CUI [1])
C0337438 (UMLS CUI [2,1])
C0011947 (UMLS CUI [2,2])
Insulin Dose Stable | Insulin regime Any Non-Insulin-Dependent Diabetes Mellitus | Antidiabetics Oral Absent
Item
patients treated by stable doses of insulin (any regimen) for type 2 diabetes without any oral antidiabetic agent
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0557978 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Age
Item
age > 18 and < 83 years
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c > 7%
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Erythropoietin Dose Variability | Blood Transfusion
Item
variability in epo doses > 20% of doses (u/kg/month) or blood transfusion in the 2 previous months
boolean
C0014822 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2827666 (UMLS CUI [1,3])
C0005841 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
patients suffering from stage 3 and 4 cardiac insufficiency
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Chronic inflammatory disorder
Item
chronic inflammatory disease
boolean
C1290886 (UMLS CUI [1])
Steroid therapy
Item
steroid treatment
boolean
C0149783 (UMLS CUI [1])
Malignant Neoplasm Developmental | Malignant Neoplasm Requirement Chemotherapy | Malignant Neoplasm Requirement Therapeutic radiology procedure
Item
cancer (evolutive or requiring chemotherapy or radiotherapy)
boolean
C0006826 (UMLS CUI [1,1])
C0458003 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
Patient scheduled for surgery
Item
patient waiting for programmed surgery
boolean
C3242215 (UMLS CUI [1])
Cardiovascular Disease | Cerebrovascular accident | Coronary heart disease | Hospitalization Due to Heart Failure
Item
history of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0010068 (UMLS CUI [3])
C3898876 (UMLS CUI [4])
Patient Non-Compliance
Item
non-compliant patients
boolean
C0376405 (UMLS CUI [1])
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