ID

37391

Beschrijving

The Mobile Diabetes Mgmt. Study With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02451631

Link

https://clinicaltrials.gov/show/NCT02451631

Trefwoorden

Versies (1)
  1. 22-07-19 22-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02451631

Engels

Eligibility Type 2 Diabetes NCT02451631

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
20-80 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months)
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral Stable | Insulin | Life Style Improvement

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0021641
UMLS CUI [4,1]
C0023676
UMLS CUI [4,2]
C2986411
in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day
Beschrijving

Insulin regime | Basal insulin times/day | Premixed insulin times/day

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C0650607
UMLS CUI [2,2]
C0439511
UMLS CUI [3,1]
C2069057
UMLS CUI [3,2]
C0439511
hba1c between 7.0% and 10.0%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
ability to understand and use smartphone application
Beschrijving

Comprehension Smartphone Application | Use of Smartphone Application

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C3204335
UMLS CUI [1,3]
C0870325
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C3204335
UMLS CUI [2,3]
C0870325
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes or patients using insulin pump
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Use of Insulin pump

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C1140609
severe complications (stage iv,v chronic kidney failure, diabetic food complications, unstable angina pectoris, mi or stroke, surgical procedure of coronary & peripheral artery within recent 6 months)
Beschrijving

Complication Severe | Chronic Kidney Failure Stage | Complications of Diabetes Mellitus Food Related | Angina, Unstable | Myocardial Infarction | Cerebrovascular accident | Operative procedure on coronary artery | Peripheral artery Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022661
UMLS CUI [2,2]
C1306673
UMLS CUI [3,1]
C0342257
UMLS CUI [3,2]
C0016452
UMLS CUI [3,3]
C0439849
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0190188
UMLS CUI [8,1]
C0489868
UMLS CUI [8,2]
C0543467
uncontrolled hypertension
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
pregnant woman, fertile woman who will not use contraception
Beschrijving

Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
unable to use application during treatment
Beschrijving

Use of Application Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0185125
UMLS CUI [1,3]
C1299582
taking medication which can affect on glucose level
Beschrijving

Pharmaceutical Preparations Affecting Glucose level

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0337438
alcohol abuse or dependency
Beschrijving

Alcohol abuse | Alcoholic Intoxication, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0001973
over 2.5 times from the upper limit of liver enzyme level
Beschrijving

Elevated liver enzymes level

Datatype

boolean

Alias
UMLS CUI [1]
C0857093
dka(diabetic ketoacidosis) or hhs(hyperglycemic hyperosmolar syndrome) history during recent 6 months
Beschrijving

Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C3888846
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Similar models

Eligibility Type 2 Diabetes NCT02451631

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
20-80 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral Stable | Insulin | Life Style Improvement
Item
type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months)
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0021641 (UMLS CUI [3])
C0023676 (UMLS CUI [4,1])
C2986411 (UMLS CUI [4,2])
Insulin regime | Basal insulin times/day | Premixed insulin times/day
Item
in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day
boolean
C0557978 (UMLS CUI [1])
C0650607 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C2069057 (UMLS CUI [3,1])
C0439511 (UMLS CUI [3,2])
Hemoglobin A1c measurement
Item
hba1c between 7.0% and 10.0%
boolean
C0474680 (UMLS CUI [1])
Comprehension Smartphone Application | Use of Smartphone Application
Item
ability to understand and use smartphone application
boolean
C0162340 (UMLS CUI [1,1])
C3204335 (UMLS CUI [1,2])
C0870325 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C3204335 (UMLS CUI [2,2])
C0870325 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Use of Insulin pump
Item
type 1 diabetes or patients using insulin pump
boolean
C0011854 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C1140609 (UMLS CUI [2,2])
Complication Severe | Chronic Kidney Failure Stage | Complications of Diabetes Mellitus Food Related | Angina, Unstable | Myocardial Infarction | Cerebrovascular accident | Operative procedure on coronary artery | Peripheral artery Operative Surgical Procedures
Item
severe complications (stage iv,v chronic kidney failure, diabetic food complications, unstable angina pectoris, mi or stroke, surgical procedure of coronary & peripheral artery within recent 6 months)
boolean
C0009566 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022661 (UMLS CUI [2,1])
C1306673 (UMLS CUI [2,2])
C0342257 (UMLS CUI [3,1])
C0016452 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0190188 (UMLS CUI [7])
C0489868 (UMLS CUI [8,1])
C0543467 (UMLS CUI [8,2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Unwilling
Item
pregnant woman, fertile woman who will not use contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Use of Application Unable
Item
unable to use application during treatment
boolean
C1524063 (UMLS CUI [1,1])
C0185125 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Pharmaceutical Preparations Affecting Glucose level
Item
taking medication which can affect on glucose level
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0337438 (UMLS CUI [1,3])
Alcohol abuse | Alcoholic Intoxication, Chronic
Item
alcohol abuse or dependency
boolean
C0085762 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
Elevated liver enzymes level
Item
over 2.5 times from the upper limit of liver enzyme level
boolean
C0857093 (UMLS CUI [1])
Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic Syndrome
Item
dka(diabetic ketoacidosis) or hhs(hyperglycemic hyperosmolar syndrome) history during recent 6 months
boolean
C0011880 (UMLS CUI [1])
C3888846 (UMLS CUI [2])
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