Inpatient Diabetes on Corticosteroids
9 de septiembre de 2019 actualizado por: Hennepin Healthcare Research Institute
Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia.
Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids.
NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen.
Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay.
The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
As above.
Tipo de estudio
Intervencionista
Inscripción (Actual)
85
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55415
- Hennepin County Medical Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 79 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Prior history of diabetes
- Able to provide informed consent
- Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
- Expect to be hospitalized for 48 hours
Exclusion Criteria:
- Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2
- ALT (alanine aminotransferase) > 2 times upper normal for laboratory
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: NPH with steroid dose
Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg |
NPH given per study table based on steroid dose and patient weight in kg.
Otros nombres:
Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl.
Administered qid during study duration.
Otros nombres:
|
|
Comparador activo: Control - Background and correction insulin
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
|
Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl.
Administered qid during study duration.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean POC Glucose Level Between Groups
Periodo de tiempo: Assessed from enrollment to discharge or enrollment to day five.
|
Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention.
Values shown are the overall mean point of care blood glucose.
|
Assessed from enrollment to discharge or enrollment to day five.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Episodes of Hypoglycemia Between NPH and Control Groups
Periodo de tiempo: Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.
|
Hypoglycemia was defined as point of care glucose less than 70 mg/dL.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
Periodo de tiempo: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl.
|
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
|
Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL
Periodo de tiempo: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL.
|
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
|
Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl
Periodo de tiempo: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl.
|
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
|
Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL
Periodo de tiempo: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements > 400 mg/dL.
|
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
|
Difference in Length of Stay Between NPH and Control Group
Periodo de tiempo: Measured from the day of admission till the day of discharge
|
Time difference of hospitalization between the NPH and control groups.
|
Measured from the day of admission till the day of discharge
|
|
Mean Point of Care (POC) Glucose Level in Both Groups.
Periodo de tiempo: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
|
The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.
|
On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
|
|
Mean Point of Care (POC) Glucose Level in Both Groups.
Periodo de tiempo: On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
|
The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.
|
On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
|
|
Correlation of C-peptide With Age
Periodo de tiempo: plasma C-peptide was measured once at the time of enrollment
|
plasma C-peptide was measured once at the time of enrollment
|
|
|
Correlation of C-peptide With BMI
Periodo de tiempo: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
|
|
Correlation of C-peptide With eGFR
Periodo de tiempo: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
|
|
Correlation of C-peptide With Serum Creatinine
Periodo de tiempo: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
|
|
Correlation of C-peptide With ALT
Periodo de tiempo: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
|
|
Correlation of C-peptide With Hemoglobin A1c
Periodo de tiempo: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
|
|
Correlation of C-peptide With Duration of Diabetes
Periodo de tiempo: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
|
|
Correlation of C-peptide With Plasma Glucose
Periodo de tiempo: Measured the time of enrollment
|
Measured the time of enrollment
|
|
|
Correlation of C-peptide With Length of Stay
Periodo de tiempo: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lisa Fish, MD, Hennepin County Medical Center, Minneapolis
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2014
Finalización primaria (Actual)
1 de junio de 2016
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
4 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
24 de octubre de 2013
Publicado por primera vez (Estimar)
28 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MMRF-13-3658
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. .