IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT04230694 para Diabetes, Diabetes mellitus, Glucosa, alta en sangre, Glucose, Low Blood está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un estudio coincide con los criterios de filtro
Vista de tarjeta
Continuous Glucose Monitoring of Hospitalized Patients With Diabetes 40
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT04230694 es un estudio intervencionista para Diabetes, Diabetes mellitus, Glucosa, alta en sangre, Glucose, Low Blood. Su estado actual es: activo, no reclutando. El estudio se inició el 20 de septiembre de 2021, con el objetivo de reclutar a 40 participantes. Dirigido por Baylor Research Institute, se espera que finalice el 31 de diciembre de 2024. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de diciembre de 2024.
Resumen
Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients with diabetes in ambulatory care settings yet is rarely provided during hospitalization. CGM of inpatients has the potential to be the care delivery innovation that is feasible, cost effective and can improve glucose control, especially by reducing hypoglycemic events. Studies of CGM use in the ICU setting have been ...Mostrar más
Descripción detallada
AIM
1) Test the health impact of CGM of inpatients as defined by rates of hypo- and hyperglycemia and the derivative of time in appropriate glucose range. Forty (40) patients will be randomized 1:1 into one of two conditions. In the treatment condition, patients will receive a Dexcom Gen6 device and the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will be trained to use readings f...
Mostrar másTítulo oficial
Continuous Glucose Monitoring of Hospitalized Patients With Diabetes: A Pilot Study to Establish Evidence
Condiciones médicas
DiabetesDiabetes mellitusGlucosa, alta en sangreGlucose, Low BloodPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- 018-601
Número del NCT
Inicio del estudio (real)
2021-09-20
Última actualización
2024-12-03
Fecha de finalización (estimada)
2024-12-31
Inscripción (prevista)
40
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Activo, no reclutando
Palabras clave
diabetes
Objetivo principal
Diagnóstico
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Comparador activoControl Group Control Group subjects will wear the CGM device during their hospitalization, up to 10 days, but glucose readings will NOT be continuously monitored. Control Group subjects will have their glucose management guided by routine standard of care finger sticks. The readings from the CGM device are recorded and reviewed retrospectively, but not used for glucose management during the hospital stay. | Dexcom Generation 6 CGM (Dexcom Gen6) device Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings. |
ExperimentalTreatment Group Treatment Group subjects will wear the CGM device during their hospitalization, up to 10 days, and glucose readings WILL be continuously monitored. Treatment Group subjects will have their glucose management guided by readings from the CGM device and standard of care finger sticks. | Dexcom Generation 6 CGM (Dexcom Gen6) device Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of Hypoglycemia Events during hospitalization | Dexcom Gen6 readings | Up to 10 days |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of Hyperglycemia Events during hospitalization | Dexcom Gen6 readings | Up to 10 days |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Patients with Type 1 and Type 2 diabetes.
- Subjects 18 years of age or older with diabetes.
- Subjects willing to avoid using high dose acetaminophen (defined as greater than 4 gm per day)
- Subjects with expected hospital length-of-stay of 2 or more days beyond the time of enrollment.
- Subjects willing to wear CGM device.
- Female subjects who are pregnant or lactating at the time of enrollment into the study. Females with childbearing potential will be queried about the possibility of pregnancy and a serum pregnancy test will be performed.
- Subjects with greater than 4gm use of Tylenol/24 hr.
- Surgical patients or patients with pre-planned surgery or procedure in the next 48 hours.
- Subjects with acute illness admitted to the ICU or expected to require admission to the ICU.
- Patients who may potentially require IV insulin.
- Patients with skin lesions, severe psoriasis, burns, tattoos, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
- Patient with a known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Patients who have had organ transplant.
- Patients with any severe medical conditions such as end-stage renal disease on dialysis, status post renal transplantation, end-stage liver disease with diffuse anasarca, heart failure on inotropic support, Ejection Fraction (EF) < 15 % or severe sepsis.
- Any condition for which, in the opinion of the investigators, it would not be in the best interest of the participant.
- Legally protected subjects (under judicial protection, guardianship, or supervision), persons deprived of their liberty, mental or language barriers rendering the subject unable to understand the nature, scope and possible consequences of the study.
- Subjects with active substance abuse.
- Subjects with infaust prognosis.
Baylor Research InstituteNo hay datos de contacto.
1 Centros del estudio en 1 países
Texas
Baylor Scott & White Medical Center - Temple, Temple, Texas, 76508, United States