ID

37304

Beskrivning

How to be Safe With Alcoholic Drinks in Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02518022

Länk

https://clinicaltrials.gov/show/NCT02518022

Nyckelord

Versioner (1)
  1. 2019-07-15 2019-07-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT02518022

Engelsk

Eligibility Type 1 Diabetes Mellitus NCT02518022

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent by participants
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
signed informed consent by parent or legal guardian of adolescent participants <18 years of age
Beskrivning

Informed Consent Parent | Informed Consent Guardian | Adolescent | Age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
UMLS CUI [3]
C0205653
UMLS CUI [4]
C0001779
age between16-21 years (both including)
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
>1 year type 1 diabetes
Beskrivning

Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
continuous subcutaneous insulin infusion for at least 3 months
Beskrivning

Continuous subcutaneous infusion of insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0393124
hba1c 7-10 % (both including)
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
bmi between10-95th percentile for gender and age (both including) for adolescents, <95th percentile for adults
Beskrivning

Body mass index | Gender | Age | Adolescent | Adult

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0205653
UMLS CUI [5]
C0001675
ability to wear glucose sensor
Beskrivning

Ability Use of Glucose sensor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0872382
normal liver enzymes (alanine aminotransferase , aspartate transaminase , gamma-glutamyl-transferase, bilirubin) in age appropriate range by local lab
Beskrivning

Liver enzymes normal Age Appropriate | Alanine aminotransferase normal | Aspartate aminotransferase normal | Gamma-glutamyltransferase normal | Bilirubin normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0438236
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C1548787
UMLS CUI [2]
C0855620
UMLS CUI [3]
C0855624
UMLS CUI [4]
C0855631
UMLS CUI [5]
C0858307
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypoglycaemia or diabetic ketoacidosis in the past 6 month
Beskrivning

Hypoglycemia Severe | Diabetic Ketoacidosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0011880
alcohol or drug abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
psychiatric disorder
Beskrivning

Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
unstable other metabolic disease as judged by investigator
Beskrivning

Metabolic Disease Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C0443343
intake of glucocorticoids or growth hormone
Beskrivning

Glucocorticoids | Growth Hormone

Datatyp

boolean

Alias
UMLS CUI [1]
C0017710
UMLS CUI [2]
C0037663
allergy to adhesive
Beskrivning

Allergy to adhesive

Datatyp

boolean

Alias
UMLS CUI [1]
C1635164
coeliac disease
Beskrivning

Celiac Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007570
women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
Beskrivning

Childbearing Potential Pregnancy test positive | Childbearing Potential Planned Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032992
Tillbaka till toppen

Similar models

Eligibility Type 1 Diabetes Mellitus NCT02518022

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent by participants
boolean
C0021430 (UMLS CUI [1])
Informed Consent Parent | Informed Consent Guardian | Adolescent | Age
Item
signed informed consent by parent or legal guardian of adolescent participants <18 years of age
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
C0205653 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Age
Item
age between16-21 years (both including)
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
>1 year type 1 diabetes
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Continuous subcutaneous infusion of insulin
Item
continuous subcutaneous insulin infusion for at least 3 months
boolean
C0393124 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c 7-10 % (both including)
boolean
C0474680 (UMLS CUI [1])
Body mass index | Gender | Age | Adolescent | Adult
Item
bmi between10-95th percentile for gender and age (both including) for adolescents, <95th percentile for adults
boolean
C1305855 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0205653 (UMLS CUI [4])
C0001675 (UMLS CUI [5])
Ability Use of Glucose sensor
Item
ability to wear glucose sensor
boolean
C0085732 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0872382 (UMLS CUI [1,3])
Liver enzymes normal Age Appropriate | Alanine aminotransferase normal | Aspartate aminotransferase normal | Gamma-glutamyltransferase normal | Bilirubin normal
Item
normal liver enzymes (alanine aminotransferase , aspartate transaminase , gamma-glutamyl-transferase, bilirubin) in age appropriate range by local lab
boolean
C0438236 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C1548787 (UMLS CUI [1,3])
C0855620 (UMLS CUI [2])
C0855624 (UMLS CUI [3])
C0855631 (UMLS CUI [4])
C0858307 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Hypoglycemia Severe | Diabetic Ketoacidosis
Item
severe hypoglycaemia or diabetic ketoacidosis in the past 6 month
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0011880 (UMLS CUI [2])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Mental disorders
Item
psychiatric disorder
boolean
C0004936 (UMLS CUI [1])
Metabolic Disease Unstable
Item
unstable other metabolic disease as judged by investigator
boolean
C0025517 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Glucocorticoids | Growth Hormone
Item
intake of glucocorticoids or growth hormone
boolean
C0017710 (UMLS CUI [1])
C0037663 (UMLS CUI [2])
Allergy to adhesive
Item
allergy to adhesive
boolean
C1635164 (UMLS CUI [1])
Celiac Disease
Item
coeliac disease
boolean
C0007570 (UMLS CUI [1])
Childbearing Potential Pregnancy test positive | Childbearing Potential Planned Pregnancy
Item
women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0032992 (UMLS CUI [2,2])
Tillbaka till toppen 

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