ID

35738

Description

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

Link

https://clinicaltrials.gov/show/NCT02033499

Keywords

Versions (1)
  1. 3/19/19 3/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 19, 2019

DOI

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License

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

English

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

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
age > 30
Description

Age

Data type

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.
Description

Diabetes Mellitus Primary Care Provider Specified

Data type

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.
Description

Hemoglobin A1c measurement

Data type

boolean

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

Compliance behavior Random assignment Clinical trial group

Data type

boolean

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

Exclusion Criteria

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

Visit Endocrinologist | Visit Endocrinologist Planned

Data type

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
Description

Insulin use

Data type

boolean

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

Pregnancy | Pregnancy, Planned

Data type

boolean

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

Relocation of home Planned

Data type

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.
Description

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

Data type

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).
Description

Hypoglycemia | Hypoglycemia Suspected | Hypoglycemia Severe

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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