ID

35738

Descripción

Three Approaches to Glucose Monitoring in Non-insulin Treated Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02033499

Link

https://clinicaltrials.gov/show/NCT02033499

Palabras clave

Versiones (1)
  1. 19/3/19 19/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder) NCT02033499

Inglés

Eligibility DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder) NCT02033499

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of type 2 diabetes
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
age > 30
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
an established patient at the participating uncpn practice who identifies a uncpn health care provider within that practice as their primary provider of diabetes care.
Descripción

Diabetes Mellitus Primary Care Provider Specified

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1547431
UMLS CUI [1,3]
C0205369
a1c >6.5% but <9.5% within the 6 months preceding the screening call/visit, as obtained from the patient's medical record.
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
willing to comply with the results of random assignment into a study group.
Descripción

Compliance behavior Random assignment Clinical trial group

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0814868
UMLS CUI [1,3]
C1320290
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently sees or plans to see an endocrinologist or other diabetes specialist in the next year.
Descripción

Visit Endocrinologist | Visit Endocrinologist Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0259863
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C0259863
UMLS CUI [2,3]
C1301732
use of insulin
Descripción

Insulin use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0240016
is or plans to become pregnant in the next 12 months.
Descripción

Pregnancy | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
plans to relocate in the next 12 months.
Descripción

Relocation of home Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
has other conditions (e.g. renal or cardiovascular disease, poor visual acuity), other factors (e.g. frailty,) or comorbidities (e.g. cancer) that might put the patient at risk when following study protocols.
Descripción

Condition Patient At risk | Kidney Disease | Cardiovascular Disease | Reduced visual acuity | Factor Patient At risk | Frailty | Comorbidity Patient At risk | Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C1444641
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0234632
UMLS CUI [5,1]
C1521761
UMLS CUI [5,2]
C0030705
UMLS CUI [5,3]
C1444641
UMLS CUI [6]
C0424594
UMLS CUI [7,1]
C0009488
UMLS CUI [7,2]
C0030705
UMLS CUI [7,3]
C1444641
UMLS CUI [8]
C0006826
no history of significant issues with known or suspected hypoglycemia or any history of "severe" hypoglycemia (requiring assistance from a third party).
Descripción

Hypoglycemia | Hypoglycemia Suspected | Hypoglycemia Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020615
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0020615
UMLS CUI [3,2]
C0205082
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Similar models

Eligibility DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder) NCT02033499

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
a diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
age > 30
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus Primary Care Provider Specified
Item
an established patient at the participating uncpn practice who identifies a uncpn health care provider within that practice as their primary provider of diabetes care.
boolean
C0011849 (UMLS CUI [1,1])
C1547431 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
a1c >6.5% but <9.5% within the 6 months preceding the screening call/visit, as obtained from the patient's medical record.
boolean
C0474680 (UMLS CUI [1])
Compliance behavior Random assignment Clinical trial group
Item
willing to comply with the results of random assignment into a study group.
boolean
C1321605 (UMLS CUI [1,1])
C0814868 (UMLS CUI [1,2])
C1320290 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Visit Endocrinologist | Visit Endocrinologist Planned
Item
currently sees or plans to see an endocrinologist or other diabetes specialist in the next year.
boolean
C0545082 (UMLS CUI [1,1])
C0259863 (UMLS CUI [1,2])
C0545082 (UMLS CUI [2,1])
C0259863 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Insulin use
Item
use of insulin
boolean
C0240016 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
is or plans to become pregnant in the next 12 months.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Relocation of home Planned
Item
plans to relocate in the next 12 months.
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Condition Patient At risk | Kidney Disease | Cardiovascular Disease | Reduced visual acuity | Factor Patient At risk | Frailty | Comorbidity Patient At risk | Malignant Neoplasms
Item
has other conditions (e.g. renal or cardiovascular disease, poor visual acuity), other factors (e.g. frailty,) or comorbidities (e.g. cancer) that might put the patient at risk when following study protocols.
boolean
C0348080 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0234632 (UMLS CUI [4])
C1521761 (UMLS CUI [5,1])
C0030705 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0424594 (UMLS CUI [6])
C0009488 (UMLS CUI [7,1])
C0030705 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0006826 (UMLS CUI [8])
Hypoglycemia | Hypoglycemia Suspected | Hypoglycemia Severe
Item
no history of significant issues with known or suspected hypoglycemia or any history of "severe" hypoglycemia (requiring assistance from a third party).
boolean
C0020615 (UMLS CUI [1])
C0020615 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0020615 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
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