Real-time CGM in Perioperative Glycemic Management
Real-Time Continuous Glucose Monitoring in Perioperative Glycemic Management of Patients Undergoing Non-Emergency Surgery: Clinical Benefits and Performance - A Randomized Controlled Trial
This is a single-center, prospective, open-label, 1:1 randomized parallel-controlled investigator-initiated trial. A total of 120 adult patients with abnormal glucose undergoing elective or semi-elective non-emergency general or orthopedic surgery will be enrolled. Subjects are randomized to rtCGM-guided perioperative glycemic management (experimental group) or conventional POCT-only glycemic management (control group, using blinded rtCGM sensor for post-hoc data collection). The primary endpoint is hierarchical composite of postoperative length-of-stay and CGM Time-In-Range analyzed by win-ratio. Secondary objectives include glycemic metrics, rtCGM accuracy, postoperative complications, hypoglycemia/hyperglycemia events, health-economic indexes and satisfaction assessments. Safety including adverse events and device-related reactions will be descriptively evaluated. Follow-up includes in-hospital monitoring plus telephone follow-up 30 days after surgery.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Diabetes and stress hyperglycemia are common among perioperative surgical patients and are associated with higher risks of postoperative infection, complications and prolonged hospital stay. Real-time continuous glucose monitoring (rtCGM) can capture continuous interstitial glucose data including asymptomatic hypo- and hyperglycemia, which may optimize perioperative glycemic control. This single-center, prospective, open-label, randomized parallel-controlled trial aims to compare perioperative glycemic management guided by real-time continuous glucose monitoring versus conventional point-of-care capillary glucose testing (POCT) among adults with abnormal glucose receiving non-emergency elective or semi-elective general or orthopedic surgery. One-hundred-twenty eligible subjects will be randomized 1:1 into experimental rtCGM group or POCT control group. Experimental group uses visible rtCGM (Sinocare iCan h6) as main monitoring tool, supplemented by POCT when clinically indicated. Control group wears blinded rtCGM sensor (data and alarms disabled for clinical use) and is managed exclusively by routine POCT finger-stick glucose. Both groups target perioperative glucose 5.6-10.0 mmol/L, and clinical treatment including anti-hyperglycemic drugs and surgical procedures follows standard hospital practice without protocol-mandated modifications. Primary endpoint is hierarchical composite of postoperative length of hospital stay (first priority) and CGM Time-In-Range (TIR, second priority), evaluated with win-ratio analysis. Secondary endpoints cover multiple glycemic variability indices, rtCGM accuracy metrics (MARD, Clarke error grid, Bland-Altman), postoperative complication rates, hypoglycemia and severe metabolic event rates, 30-day unplanned readmission / emergency visit rates, total hospitalization costs, patient and healthcare-worker satisfaction. Safety assessment collects all adverse events, serious adverse events and device-related adverse reactions up to 30 days post-surgery. Study includes screening/baseline period, perioperative in-hospital intervention period, discharge visit, and post-operative 30-day ±3-day telephone follow-up. Statistical analysis will adopt full analysis set (FAS) as primary population; per-protocol set (PPS) and safety set (SS) will also be analyzed.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 18-75 years inclusive at the time of signing informed consent, any gender.
- Scheduled for elective surgery with expected perioperative glycemic monitoring.
- Expected postoperative hospital stay ≥ 24 hours.
- Able to understand and voluntarily sign the written informed consent form.
- Agree to wear the CGM sensor during the perioperative in-hospital period.
Exclusion Criteria:
- History of type 1 diabetes mellitus.
- Severe skin disease or known allergy to CGM sensor adhesive material.
- Planned surgery duration less than 1 hour.
- Severe hepatic or renal dysfunction requiring dialysis.
- Pregnant or breastfeeding women.
- Enrolled in another interventional clinical trial that may interfere with glycemic management.
- Conditions that preclude reliable CGM data acquisition.
- Investigator judgment that the participant is unsuitable to enter this trial for any other reason.
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: Real-time CGM group
Participants use real-time continuous glucose monitoring (rtCGM) for perioperative glycemic management, with glucose alerts and real-time glucose data available to clinicians. |
Real-time continuous glucose monitoring is used during the perioperative period. Clinicians can view live glucose readings and alerts to guide glycemic adjustment. |
|
Comparador activo: Conventional POCT group
Participants receive conventional point-of-care blood glucose testing. A blinded CGM sensor is worn for data collection only; glucose values are not accessible to clinical staff. |
Perioperative glycemic management is performed with routine point-of-care blood glucose testing. Participants wear a blinded CGM sensor only for research data collection; real-time glucose data and alerts are not available to the clinical team for treatment decisions. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hierarchical composite endpoint of postoperative length of hospital stay and CGM-derived time in range (TIR)
Periodo de tiempo: From the day of surgery until hospital discharge, whichever comes first, assessed up to 30 days
|
Hierarchical rank-based composite endpoint assessed by win-ratio analysis (Finkelstein-Schoenfeld method). First priority: postoperative length of hospital stay, defined as integer days from the day of surgery to discharge (discharge day is excluded from counting). Second priority: CGM-derived percentage time in range (TIR), glucose within 5.6-10.0 mmol/L, only compared for participant pairs tied at the first-priority endpoint. |
From the day of surgery until hospital discharge, whichever comes first, assessed up to 30 days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- SN-CGM-PO-003
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .