ID

33155

Descripción

Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT01176149

Link

https://clinicaltrials.gov/show/NCT01176149

Palabras clave

Versiones (1)
  1. 29/11/18 29/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT01176149

Inglés

Eligibility Type 2 Diabetes NCT01176149

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
patients on treatment with oha monotherapy (i.e. metformin alone or sulphonylureas alone or tzds alone);
Descripción

Oral hypoglycemic | Metformin | Sulfonylureas | Thiazolidinediones

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0038766
UMLS CUI [4]
C1257987
no need for insulin treatment;
Descripción

Requirement Absent Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0557978
male and female patients, aged between 45-75 years;
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
no experience of self monitoring of blood glucose in the previous 12 months (smbg performed with a frequency of < 1 times/week)
Descripción

Experience Absent Blood Glucose Self-Monitoring

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0596545
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0005803
ability and willingness to comply with all study requirements
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
signature of consent form
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients incapable to perform smbg
Descripción

Blood Glucose Self-Monitoring Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C1299582
patients needing insulin or multiple oha association therapy
Descripción

Patient need for Insulin | Patient need for Oral hypoglycemic Multiple therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021641
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0359086
UMLS CUI [2,3]
C3854359
patients needing a regular use of smbg (e.g. frequent hypoglycemic episodes)
Descripción

Patient need for Blood Glucose Self-Monitoring Regular | Hypoglycaemic episode Frequent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0005803
UMLS CUI [1,3]
C0205272
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0332183
diabetes care not exclusively managed by diabetic clinics
Descripción

Diabetic care Did not attend diabetic clinic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0150544
UMLS CUI [1,2]
C1272080
patients with serious underlying medical or psychiatric condition
Descripción

Medical condition Serious | Mental condition Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0205404
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Similar models

Eligibility Type 2 Diabetes NCT01176149

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
boolean
C0011860 (UMLS CUI [1])
Oral hypoglycemic | Metformin | Sulfonylureas | Thiazolidinediones
Item
patients on treatment with oha monotherapy (i.e. metformin alone or sulphonylureas alone or tzds alone);
boolean
C0359086 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
Requirement Absent Insulin regime
Item
no need for insulin treatment;
boolean
C1514873 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [1,3])
Age
Item
male and female patients, aged between 45-75 years;
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
boolean
C0474680 (UMLS CUI [1])
Experience Absent Blood Glucose Self-Monitoring
Item
no experience of self monitoring of blood glucose in the previous 12 months (smbg performed with a frequency of < 1 times/week)
boolean
C0596545 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005803 (UMLS CUI [1,3])
Protocol Compliance
Item
ability and willingness to comply with all study requirements
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
signature of consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Blood Glucose Self-Monitoring Unable
Item
patients incapable to perform smbg
boolean
C0005803 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Patient need for Insulin | Patient need for Oral hypoglycemic Multiple therapy
Item
patients needing insulin or multiple oha association therapy
boolean
C0686904 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0359086 (UMLS CUI [2,2])
C3854359 (UMLS CUI [2,3])
Patient need for Blood Glucose Self-Monitoring Regular | Hypoglycaemic episode Frequent
Item
patients needing a regular use of smbg (e.g. frequent hypoglycemic episodes)
boolean
C0686904 (UMLS CUI [1,1])
C0005803 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0745153 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
Diabetic care Did not attend diabetic clinic
Item
diabetes care not exclusively managed by diabetic clinics
boolean
C0150544 (UMLS CUI [1,1])
C1272080 (UMLS CUI [1,2])
Medical condition Serious | Mental condition Serious
Item
patients with serious underlying medical or psychiatric condition
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3840291 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
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