ID

32892

Beschrijving

Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study; ODM derived from: https://clinicaltrials.gov/show/NCT00874809

Link

https://clinicaltrials.gov/show/NCT00874809

Trefwoorden

Versies (1)
  1. 19-11-18 19-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00874809

Engels

Eligibility Type 2 Diabetes Mellitus NCT00874809

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes > 3month duration
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
age 18
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
hb a1c <12%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
on any hypoglycemic therapy including insulin for 5 patients and 5 patients naive to insulin and failing oral treatment
Beschrijving

Patients Quantity | Hypoglycemic Agents | Insulin | Patients Quantity | Insulin Absent | Oral medication failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0020616
UMLS CUI [3]
C0021641
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C0021641
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0175795
UMLS CUI [6,2]
C0231175
normal creatine
Beschrijving

Creatine normal

Datatype

boolean

Alias
UMLS CUI [1]
C0860943
negative for gad antibodies
Beschrijving

Anti-GAD antibody negative

Datatype

boolean

Alias
UMLS CUI [1]
C1167898
smbg >4/d and willing/able to comply with study requirements
Beschrijving

Blood Glucose Self-Monitoring times/day | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0439511
UMLS CUI [2]
C0525058
demonstrated adherence to visits and instructions.
Beschrijving

Adherence Visits | Adherence Instructions

Datatype

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0008952
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C2051542
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypoglycemic during the last month
Beschrijving

Hypoglycemia Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
severe cardiac, pulmonary or cerebral disease
Beschrijving

Heart Disease Severe | Lung disease Severe | Cerebral disorder Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0234387
UMLS CUI [3,2]
C0205082
demonstrated non compliance with clinical recommendations
Beschrijving

Compliance behavior Absent Recommendations Clinical

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0034866
UMLS CUI [1,4]
C0205210
pregnancy, nursing or women who could potentially become pregnant
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
presence of physical, psychological or cognitive impairments that would interfere with adherence to an intensive insulin therapy program or compliance with dietary, diary keeping or maintenance of cgm sensor or pump
Beschrijving

Physical impairment Interferes with Insulin regime | Mental impairment Interferes with Insulin regime | Impaired cognition Interferes with Insulin regime | Physical impairment Interferes with Protocol Compliance | Mental impairment Interferes with Protocol Compliance | Impaired cognition Interferes with Protocol Compliance | Diary Dietary Completion | Maintenance CGM sensor | Maintenance CGM pump

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231171
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0557978
UMLS CUI [2,1]
C0683322
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0557978
UMLS CUI [3,1]
C0338656
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0557978
UMLS CUI [4,1]
C0231171
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0683322
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0338656
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C3890583
UMLS CUI [7,2]
C0012155
UMLS CUI [7,3]
C0205197
UMLS CUI [8,1]
C0024501
UMLS CUI [8,2]
C4523945
UMLS CUI [8,3]
C0183210
UMLS CUI [9,1]
C0024501
UMLS CUI [9,2]
C4523945
UMLS CUI [9,3]
C0182537
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00874809

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
type 2 diabetes > 3month duration
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Age
Item
age 18
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hb a1c <12%
boolean
C0474680 (UMLS CUI [1])
Patients Quantity | Hypoglycemic Agents | Insulin | Patients Quantity | Insulin Absent | Oral medication failed
Item
on any hypoglycemic therapy including insulin for 5 patients and 5 patients naive to insulin and failing oral treatment
boolean
C0030705 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020616 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
C0030705 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0175795 (UMLS CUI [6,1])
C0231175 (UMLS CUI [6,2])
Creatine normal
Item
normal creatine
boolean
C0860943 (UMLS CUI [1])
Anti-GAD antibody negative
Item
negative for gad antibodies
boolean
C1167898 (UMLS CUI [1])
Blood Glucose Self-Monitoring times/day | Protocol Compliance
Item
smbg >4/d and willing/able to comply with study requirements
boolean
C0005803 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Adherence Visits | Adherence Instructions
Item
demonstrated adherence to visits and instructions.
boolean
C1510802 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C1510802 (UMLS CUI [2,1])
C2051542 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypoglycemia Severe
Item
severe hypoglycemic during the last month
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Heart Disease Severe | Lung disease Severe | Cerebral disorder Severe
Item
severe cardiac, pulmonary or cerebral disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0234387 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Compliance behavior Absent Recommendations Clinical
Item
demonstrated non compliance with clinical recommendations
boolean
C1321605 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0034866 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
Pregnancy | Breast Feeding | Childbearing Potential
Item
pregnancy, nursing or women who could potentially become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Physical impairment Interferes with Insulin regime | Mental impairment Interferes with Insulin regime | Impaired cognition Interferes with Insulin regime | Physical impairment Interferes with Protocol Compliance | Mental impairment Interferes with Protocol Compliance | Impaired cognition Interferes with Protocol Compliance | Diary Dietary Completion | Maintenance CGM sensor | Maintenance CGM pump
Item
presence of physical, psychological or cognitive impairments that would interfere with adherence to an intensive insulin therapy program or compliance with dietary, diary keeping or maintenance of cgm sensor or pump
boolean
C0231171 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0557978 (UMLS CUI [1,3])
C0683322 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0557978 (UMLS CUI [2,3])
C0338656 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0557978 (UMLS CUI [3,3])
C0231171 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0683322 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0338656 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C3890583 (UMLS CUI [7,1])
C0012155 (UMLS CUI [7,2])
C0205197 (UMLS CUI [7,3])
C0024501 (UMLS CUI [8,1])
C4523945 (UMLS CUI [8,2])
C0183210 (UMLS CUI [8,3])
C0024501 (UMLS CUI [9,1])
C4523945 (UMLS CUI [9,2])
C0182537 (UMLS CUI [9,3])
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