- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00522210
Comparison of a Twice Daily Versus a Three Times Daily Insulin Regimen in Children With Type 1 Diabetes
A Comparison of Insulin Detemir in a BID Insulin Regimen Versus a TID Insulin Regimen in Children With Type 1 Diabetes: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Children with type 1 diabetes (DM1) can only be treated with subcutaneous insulin at the present time in Canada. It has been shown that intensive insulin treatment using at least three times daily (TID) insulin injections achieves superior blood glucose control with less long term complications of diabetes than conventional insulin treatment using once daily (OD) or twice daily (BID) insulin injections. However, many patients find it difficult to adhere to TID insulin injections since it is an invasive and painful therapy, which results in frequent insulin omission.
This study is a randomized controlled open-labeled non-inferiority trial to compare the glycemic control as measured by HbA1c after 6 months of a BID insulin regimen using detemir insulin, or the currently used TID insulin with intermediate acting insulin (Novolin NPH or Humulin N). Patients will be randomized to either the active control group (standard TID regimen) or the treatment group (BID regimen with new long acting insulin analogue). A run-in period of 1 month will be used to facilitate the change in insulin regimen. Insulin doses will be adjusted by weekly phone contact with the research nurse for one month prior to baseline blood work. Patients will continue on the same diet and exercise routine as recommended by their usual diabetes team. They will also be seen every 3 months by the research nurse to review blood glucose, assess height and weight and arrange for blood work to be done in conjunction with their routine bloodwork. All patients will continue to be seen by their usual diabetologist, nurse, and dietician at their regularly scheduled clinic visits (every 3 months).
Outcomes include: HA1c between groups at 6 months (surrogate marker of metabolic control for diabetes measured through a venous or capillary blood sample), frequency of adverse events (severe hypoglycemia, mild hypoglycemia, episodes of diabetic ketoacidosis, weight gain), diabetes quality of life for youth (DQOL).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T3B 6A8
- Alberta Children's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Children with DM1 6-17 years old that are currently on a TID regimen of insulin with rapid acting insulin and intermediate acting insulin.
- Currently being followed at the Alberta Children's Hospital Diabetes Clinic.
- Duration of diabetes of at least 12 months.
Exclusion Criteria:
- Children younger than 6 years of age will be excluded since long-acting analogue has not been approved in children younger than 6 years old.
- Children with compromised metabolic control (HA1c greater than 10%).
- Children with other chronic underlying medical conditions that could affect glycemic control i.e. uncontrolled hypothyroidism, hyperthyroidism, celiac disease, etc.
- Language or psychosocial barrier preventing the family from completing the study.
- Diabetes duration of less than 12 months.
- Participation in other clinical trials with specified clinic visit schedule.
- Patients currently on insulin pump therapy or multiple daily injections of greater than three injections per day.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: BID insulin with LA analogue
Treatment Group: BID Insulin Regimen with Long Acting Insulin Analogue (Detemir)
|
Patients will discontinue their usual bedtime dose of intermediate acting insulin and replace this with the same unit dose of detemir at supper time.
The detemir will not be mixed with the rapid acting insulin and will be given as a separate injection.
The patient's morning dose of intermediate acting insulin will be decreased by 20% to adjust for the longer duration of action of detemir.
Doses of rapid acting insulin will remain the same at breakfast and at supper.
Otros nombres:
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Comparador activo: Standard TID insulin
Active Control Group: Usual TID Insulin Regimen (intermediate insulin- Humulin N or Novolin NPH)
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Patients will continue on their usual insulin regimen of insulin three times per day.
Intermediate and rapid acting insulin at breakfast, rapid acting insulin at supper, and intermediate acting insulin at bedtime.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Hemoglobina a1c
Periodo de tiempo: 6 meses
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6 meses
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of episodes of hypoglycemia (severe and mild)
Periodo de tiempo: 6 months
|
6 months
|
Number of episodes of diabetic ketoacidosis (DKA)
Periodo de tiempo: 6 months
|
6 months
|
Body Mass Index (BMI) kg/m2
Periodo de tiempo: 6 months
|
6 months
|
Diabetes Quality of Life Questionaire-youth version
Periodo de tiempo: 6 months
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Josephine Ho, MD, University of Calgary
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Diabetes Mellitus, Tipo 1
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Insulina
- Insulina Isófana, Humana
Otros números de identificación del estudio
- E-20635
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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