ID

29052

Descripción

International Navigator Hypoglycaemia Study; ODM derived from: https://clinicaltrials.gov/show/NCT00843609

Link

https://clinicaltrials.gov/show/NCT00843609

Palabras clave

Versiones (1)
  1. 22/2/18 22/2/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de febrero de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Diabetes Mellitus, Type 1 NCT00843609

Inglés

Eligibility Diabetes Mellitus, Type 1 NCT00843609

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject with type 1 diabetes (> 1year since diagnosis)
Descripción

Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
csii or mdi
Descripción

Continuous subcutaneous infusion of insulin | Injection of insulin Daily Dose Multiple

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0393124
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C2348070
UMLS CUI [2,3]
C0439064
hba1c at inclusion < 7.5 %
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
no concomitant diseases that influence metabolic control
Descripción

Absence Comorbidity Influence Metabolic Control

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009488
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C1513158
no current use of cgm
Descripción

Blood glucose monitoring Continuous Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1820407
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has known allergy to medical grade adhesives
Descripción

Hypersensitivity Adhesives Medical

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001516
UMLS CUI [1,3]
C0205476
subject has a medical condition, which in the investigator's opinion, may compromise patient safety
Descripción

Medical condition compromises Patient safety

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
Descripción

Study Subject Participation Status | Glucose monitoring device Affecting Glucose measurement | Glucose monitoring device Affecting Blood glucose management | Investigational New Drugs Affecting Glucose measurement | Investigational New Drugs Affecting Blood glucose management

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0202048
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0337438
UMLS CUI [3,1]
C0202048
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1638311
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0337438
UMLS CUI [5,1]
C0013230
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1638311
subject is currently using another cgm device or has used real-time continuous glucose monitoring in the previous 4 weeks
Descripción

Blood glucose monitoring Continuous | Medical Device Other | Blood glucose monitoring Continuous Real Time

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1820407
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0025080
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C1820407
UMLS CUI [3,2]
C0549178
UMLS CUI [3,3]
C1550177
subject is receiving peritoneal dialysis solutions containing icodextrin
Descripción

Peritoneal dialysis solution Containing Icodextrin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0353714
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0538727
female subject who is pregnant or planning to become pregnant within the planned study duration
Descripción

Pregnancy | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
Volver a la parte superior de la página

Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00843609

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
subject with type 1 diabetes (> 1year since diagnosis)
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Continuous subcutaneous infusion of insulin | Injection of insulin Daily Dose Multiple
Item
csii or mdi
boolean
C0393124 (UMLS CUI [1])
C0199782 (UMLS CUI [2,1])
C2348070 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
Glucohemoglobin measurement
Item
hba1c at inclusion < 7.5 %
boolean
C0202054 (UMLS CUI [1])
Absence Comorbidity Influence Metabolic Control
Item
no concomitant diseases that influence metabolic control
boolean
C0332197 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C1513158 (UMLS CUI [1,4])
Blood glucose monitoring Continuous Absent
Item
no current use of cgm
boolean
C1820407 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Adhesives Medical
Item
subject has known allergy to medical grade adhesives
boolean
C0020517 (UMLS CUI [1,1])
C0001516 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
Medical condition compromises Patient safety
Item
subject has a medical condition, which in the investigator's opinion, may compromise patient safety
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
Study Subject Participation Status | Glucose monitoring device Affecting Glucose measurement | Glucose monitoring device Affecting Blood glucose management | Investigational New Drugs Affecting Glucose measurement | Investigational New Drugs Affecting Blood glucose management
Item
subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
boolean
C2348568 (UMLS CUI [1])
C0202048 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0337438 (UMLS CUI [2,3])
C0202048 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1638311 (UMLS CUI [3,3])
C0013230 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0337438 (UMLS CUI [4,3])
C0013230 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1638311 (UMLS CUI [5,3])
Blood glucose monitoring Continuous | Medical Device Other | Blood glucose monitoring Continuous Real Time
Item
subject is currently using another cgm device or has used real-time continuous glucose monitoring in the previous 4 weeks
boolean
C1820407 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0025080 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1820407 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
C1550177 (UMLS CUI [3,3])
Peritoneal dialysis solution Containing Icodextrin
Item
subject is receiving peritoneal dialysis solutions containing icodextrin
boolean
C0353714 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0538727 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
female subject who is pregnant or planning to become pregnant within the planned study duration
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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