ID

37304

Description

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

Lien

https://clinicaltrials.gov/show/NCT02518022

Mots-clés

Versions (1)
  1. 15/07/2019 15/07/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

15 juillet 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Type 1 Diabetes Mellitus NCT02518022

Anglais

Eligibility Type 1 Diabetes Mellitus NCT02518022

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent by participants
Description

Informed Consent

Type de données

boolean

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

Informed Consent Parent | Informed Consent Guardian | Adolescent | Age

Type de données

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)
Description

Age

Type de données

boolean

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

Insulin-Dependent Diabetes Mellitus Disease length

Type de données

boolean

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

Continuous subcutaneous infusion of insulin

Type de données

boolean

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

Hemoglobin A1c measurement

Type de données

boolean

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

Body mass index | Gender | Age | Adolescent | Adult

Type de données

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
Description

Ability Use of Glucose sensor

Type de données

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
Description

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

Type de données

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
Description

Exclusion Criteria

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

Hypoglycemia Severe | Diabetic Ketoacidosis

Type de données

boolean

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

Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
psychiatric disorder
Description

Mental disorders

Type de données

boolean

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

Metabolic Disease Unstable

Type de données

boolean

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

Glucocorticoids | Growth Hormone

Type de données

boolean

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

Allergy to adhesive

Type de données

boolean

Alias
UMLS CUI [1]
C1635164
coeliac disease
Description

Celiac Disease

Type de données

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
Description

Childbearing Potential Pregnancy test positive | Childbearing Potential Planned Pregnancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032992
Retour au début de la page

Similar models

Eligibility Type 1 Diabetes Mellitus NCT02518022

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial