ID

29091

Descripción

Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00964574

Link

https://clinicaltrials.gov/show/NCT00964574

Palabras clave

Versiones (1)
  1. 23/2/18 23/2/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 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 NCT00964574

Inglés

Eligibility Diabetes Mellitus, Type 1 NCT00964574

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
Descripción

Diabetes Mellitus, Insulin-Dependent | Patient need for Insulin regime Basal | Patient need for Insulin regime Bolus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0557978
UMLS CUI [2,3]
C0650607
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0557978
UMLS CUI [3,3]
C1511237
6.5 <=hba1c <= 11% at visit 1
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
bmi <35 kg/m²
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
provision of signed and dated informed consent prior to any study procedures
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
ability and willingness to complete study diaries and questionnaires
Descripción

Subject Diary Completion | Questionnaires Completion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
Descripción

Blood Glucose Self-Monitoring | Insulin Self-injection aid Use of

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005803
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C3880392
UMLS CUI [2,3]
C1524063
a negative pregnancy test for all females of childbearing potential.
Descripción

Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to insulin glulisine, insulin glargine or one of their excipients
Descripción

Hypersensitivity Insulin Glulisine | Hypersensitivity Insulin Glargine | Hypersensitivity Insulin Glulisine Excipient | Hypersensitivity Insulin Glargine Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1313386
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0907402
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1313386
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0907402
UMLS CUI [4,3]
C0015237
pregnant women
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
active proliferative diabetic retinopathy
Descripción

Proliferative diabetic retinopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0154830
impaired hepatic or renal function
Descripción

Liver Dysfunction | Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descripción

Study Subject Participation Status Aspect Additional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1879746
UMLS CUI [1,3]
C1524062
Volver a la parte superior de la página

Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00964574

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Patient need for Insulin regime Basal | Patient need for Insulin regime Bolus
Item
patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
boolean
C0011854 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0650607 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0557978 (UMLS CUI [3,2])
C1511237 (UMLS CUI [3,3])
Glucohemoglobin measurement
Item
6.5 <=hba1c <= 11% at visit 1
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
bmi <35 kg/m²
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
provision of signed and dated informed consent prior to any study procedures
boolean
C0021430 (UMLS CUI [1])
Subject Diary Completion | Questionnaires Completion
Item
ability and willingness to complete study diaries and questionnaires
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Blood Glucose Self-Monitoring | Insulin Self-injection aid Use of
Item
demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
boolean
C0005803 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C3880392 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
Childbearing Potential Pregnancy test negative
Item
a negative pregnancy test for all females of childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Insulin Glulisine | Hypersensitivity Insulin Glargine | Hypersensitivity Insulin Glulisine Excipient | Hypersensitivity Insulin Glargine Excipient
Item
hypersensitivity to insulin glulisine, insulin glargine or one of their excipients
boolean
C0020517 (UMLS CUI [1,1])
C1313386 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1313386 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0907402 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Proliferative diabetic retinopathy
Item
active proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1])
Liver Dysfunction | Renal Insufficiency
Item
impaired hepatic or renal function
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Study Subject Participation Status Aspect Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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