IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT04818242 para Diabetes, Diabetes mellitus, tipo 2 está completado. 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
Volver a la búsqueda
Universidad EmoryDexcom Continuous Glucose Monitoring in Long-term Care 100
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 NCT04818242 fue un estudio intervencionista para Diabetes, Diabetes mellitus, tipo 2. Su estado actual es: completado. El estudio se inició el 19 de abril de 2021, con el objetivo de reclutar a 100 participantes. Dirigido por la Universidad Emory, la fecha de finalización prevista fue el 21 de octubre de 2022. Los datos se actualizaron por última vez en ClinicalTrials.gov el 13 de noviembre de 2023.
Resumen
The goal of this study is to determine whether the use of Dexcom Continuous Glucose Monitoring with Glucose Telemetry System (CGM-GTS) with hypoglycemia alarm will facilitate diabetes treatment and reduce the risk of hypoglycemia in insulin and non-insulin treated patients with type 2 diabetes (T2D) in long-term care facilities, when compared to standard of care using capillary point of care testing.
Descripción detallada
The prevalence of diabetes increases with age, and it is estimated that more than 20% of older adults aged 65-75 years and 40% of adults over 80 years of age have diabetes. The prevalence of diabetes in older adults is expected to increase due to longer life expectancy and improvements in care. The estimated prevalence of diabetes in subacute and long-term skilled nursing care facilities is reported to be around 20% ...Mostrar más
Título oficial
Randomized Controlled Trial To Assess the Benefits of Dexcom Continuous Glucose Monitoring With Glucose Telemetry System for the Management of Diabetes in Long-term Care Setting: The CGM-GTS in Long-term Care
Condiciones médicas
DiabetesDiabetes mellitus, tipo 2Otros ID del estudio
- STUDY00001529
Número del NCT
Inicio del estudio (real)
2021-04-19
Última actualización
2023-11-13
Fecha de finalización (estimada)
2022-10-21
Inscripción (prevista)
100
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Completado
Palabras clave
Continuous glucose monitoring
Glucose telemetry system
Long term care
Glucose telemetry system
Long term care
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Comparador activoPOC testing with Blinded CGM (Standard of Care) Patients in the standard of care study arm will wear a blinded CGM and receive POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results. | POC Blood Glucose Test + Blinded CGM Point of Care (POC) testing before meals and bedtime (standard of care). For the control group, participants will also get a CGM sensor (blinded CGM). CGM alarms are turned off, however if the POC is found to be between \<80 mg/dl by POC, 15 grams of carbohydrates will be given as a preventive measurement for hypoglycemia (standard of care). |
ExperimentalDexcom CGM with Glucose Telemetry System (CGM-GTS) Patients in the intervention CGM study arm will have a single daily fasting POC testing and will wear a real-time Dexcom G6 with GTS, and providers will adjust oral or insulin therapy based on CGM-GTS profile information. | Dexcom G6 CGM with GTS CGM sensor will be placed after consent. Glucose values obtained from the CGM sensor will be sent to the CGM transmitter by Bluetooth technology and Dexcom Share2 software application to a smart phone that serves as an intermediate-transmitting (routing) device. Glucose values from the smart phone will be transmitted wirelessly to a table computer (I-Pad) using the Dexcom Follow application. Information on the CGM wi...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of Participants Experiencing Hypoglycemia (BG<70 mg/dL) | The number of participants with hypoglycemia detected, where hypoglycemia is defined as blood glucose (BG) of less than 70 mg/dL. | During hospitalization (up to 60 days of admission) |
Number of Participants Experiencing Clinically Significant Hypoglycemia (BG<54 mg/dL) | Clinically significant hypoglycemia is defined as blood glucose levels less than 54 mg/dL. | During hospitalization (up to 60 days of admission) |
Time in Range (TIR) Between 70-180 mg/dL | Glycemic control is measured by time that blood glucose levels are in the range of 70 to 180 mg/dL. | During hospitalization (up to 60 days of admission) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of Events of Nocturnal Hypoglycemia | The average number of events of nocturnal hypoglycemic events across all participants for BG \< 70 mg/dL and \<54 mg/dL occurring between 22:00 and 06:00. | During hospitalization (up to 60 days of admission) |
Number of Hypoglycemia Events | The total number of events of hypoglycemia events (BG \<70 mg/dL and \<54 mg/dL) across participants. | During hospitalization (up to 60 days of admission) |
Time in Hypoglycemia (BG<70 mg/dL) | The percent of time in hypoglycemia, defined as blood glucose level \<70 mg/dL, is assessed. | During hospitalization (up to 60 days of admission) |
Percent of Time in Hypoglycemia (BG<54 mg/dL) | The percentage of time in hypoglycemia with blood glucose levels less than 54 mg/dL. | During hospitalization (up to 60 days of admission) |
Percent of Time in Hyperglycemia (BG > 180 mg/dL) | The percentage of time in hyperglycemia with blood glucose levels greater than 180 mg/dL. | During hospitalization (up to 60 days of admission) |
Percent of Time in Hyperglycemia (BG>250 mg/dL) | The percentage of time in hyperglycemia with blood glucose levels \>250 mg/dL. | During hospitalization (up to 60 days of admission) |
Number of Events of Prolonged Hypoglycemia | The number of events of prolonged hypoglycemia, defined as \> 1 and 2 hours, as determined by CGM. | During hospitalization (up to 60 days of admission) |
Number of Hypoglycemia Events During the Day and Night | The number of hypoglycemia events during the day and night in the POC testing group and the CGM-GTS group. | During hospitalization (up to 60 days of admission) |
Number of Events of Hyperglycemia > 180 mg/dL | Number of events of hyperglycemia \> 180 mg/dL during the day and night between POC testing group and CGM-GTS group | During hospitalization (up to 60 days of admission) |
Number of Events of Hyperglycemia > 240 mg/dL | Number of events of hyperglycemia \> 240 mg/dL during the day and night between POC testing group and CGM-GTS group | During hospitalization (up to 60 days of admission) |
Percentage of POC BG Readings Within Target BG of 70 and 180 mg/dL | The percentage of POC blood glucose readings within the target BG range of 70 and 180 mg/dL. | During hospitalization (up to 60 days of admission) |
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) | Mean amplitude of glycemic excursions (MAGE), together with mean and standard deviation (SD), is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one SD of mean glycemia. It is designated to assess major glucose swings and exclude minor ones. | During hospitalization (up to 60 days of admission) |
Number of Participants With Problems With Sensor Insertion | The number of participants who experienced problems or issues while the sensor was being inserted was documented. | During hospitalization (up to 60 days of admission) |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Males and females admitted to subacute and long-term skilled nursing care facilities.
- Known history of T2D treated with insulin or insulin secretagogues with or without additional oral antidiabetic agents, short- and long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA).
- Patients with an expected long-term care facility length-of-stay > 1 week.
- Patients expected to require MRI procedures during admission.
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
Universidad Emory398 estudios activos para explorarDexCom, Inc.Parte responsable del estudio
Guillermo Umpierrez, Investigador principal, Professor, Emory University
No hay datos de contacto.
2 Centros del estudio en 1 países
Georgia
A.G. Rhodes, Atlanta, Georgia, 30329, United States
Emory Wesley Woods Hospital, Atlanta, Georgia, 30329, United States