Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT

Официальное название

Application of the Hybrid Closed-Loop Artificial Pancreas System in Neurosurgical Perioperative Hyperglycemic Patients: An Open, Randomized Controlled Trial

Обзор

In this study, we plan to use an open-source hybrid closed-loop artificial pancreas system and a combination of a traditional insulin pump and continuous glucose monitoring (CGM) respectively to conduct short-term intensive insulin treatment for patients with type 2 diabetes mellitus (T2DM) during the perioperative period who are hospitalized in the Department of Neurosurgery of Shanxi Bethune Hospital. By comparing the blood glucose control status of patients under different intensive insulin treatment regimens and other clinical indicators such as postoperative complications, we will comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop artificial pancreas system.

Подробное описание

According to the inclusion and exclusion criteria, 40 perioperative patients with type 2 diabetes mellitus (T2DM) will be screened and enrolled from the neurosurgical ward of Shanxi Bethune Hospital. They will be randomly divided into two groups: 20 patients in the hybrid closed-loop artificial pancreas system group and 20 patients in the traditional pump combined with continuous glucose monitoring (CGM) group. Both groups of patients will use continuous glucose monitoring to measure blood glucose levels. After collecting baseline data, the two groups of patients will receive short-term intensive insulin therapy according to the above-mentioned plans. Relevant clinical data will be collected during and after the treatment to compare the advantages and disadvantages of the two intensive insulin treatment plans in controlling blood glucose levels in perioperative T2DM patients undergoing neurosurgery and their impact on complications.

Вмешательства

• Устройство Hybrid Closed-Loop Artificial Pancreas System
  The total daily insulin requirement is calculated as 0.3 - 0.6 U/(kg·d) according to patient's weight. The system automatically adjusts the basal rate during operation. Nurses enter bolus dose orders in AAPS software as directed by physicians. Blood glucose is monitored via continuous glucose monitoring and 4 daily fingerstick measurements (fasting and 2 hours after each meal).

Первичные конечные точки

• Time in Range (TIR) [Срок оценки: During the 5- to 7-day period of hospitalization]

Вторичные конечные точки (8)

• Blood glucose target criteria [Срок оценки: During the 5- to 7-day period of hospitalization]
• Time Below Range (TBR)、Time Above Range (TAR) [Срок оценки: During the 5- to 7-day period of hospitalization]
• Hypoglycemia Incidence Rate [Срок оценки: During the 5- to 7-day period of hospitalization]
• Blood glucose fluctuation level (IQR) [Срок оценки: During the 5- to 7-day period of hospitalization]
• Perioperative Infection Rate and Inflammatory Markers [Срок оценки: During the 5- to 7-day period of hospitalization]
• Adverse event（AE）、Serious adverse event（SAE） [Срок оценки: During the 5- to 7-day period of hospitalization]
• Perioperative infection rate and inflammatory markers [Срок оценки: During the 5- to 7-day period of hospitalization]
• Suture removal time, total hospital stay days, and postoperative hospital stay days [Срок оценки: During the 5- to 7-day period of hospitalization]

Критерии участия

Критерии включения

• Aged between 18 and 75 years old.
• Patients who have undergone neurosurgical procedures for intracranial hemorrhage (including subdural hemorrhage, basal ganglia hemorrhage, and subarachnoid hemorrhage), have a Glasgow Coma Scale score of 12 or higher after leaving the intensive care unit, receive enteral nutrition postoperatively, and have a previously established diagnosis of type 2 diabetes mellitus, or meet the diagnostic criteria for type 2 diabetes mellitus in the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes" (2020 edition) .
• Fasting blood glucose ≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L.
• Those who have signed the informed consent form and are willing to participate in this clinical trial voluntarily.

Критерии исключения

• Patients with diabetic emergencies, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.
• Patients with type 1 diabetes or other special types of diabetes.
• Patients with severe cardiac and renal dysfunction: those with cardiac function above grade III; those with serum creatinine exceeding 442 μmol/L.
• Patients with diseases that affect glucose metabolism, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
• Patients who are allergic to the drugs involved in the clinical diagnosis and treatment plan.
• Populations and contraindications that are not suitable for insulin pump treatment.
• Patients with allergic constitution and those who are allergic to adhesive tape.
• Patients with skin diseases such as rashes and prurigo, or those with abnormal coagulation function.
• Patients with impaired consciousness or mental diseases, who lack self-control and cannot express themselves clearly.
• Other situations that the researcher deems inappropriate for participating in the clinical trial.
• Patients who develop severe complications during or after surgery and are judged by the researcher as unfit for enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Shanxi Bethune Hospital — Taiyuan

Идентификаторы

NCT: NCT06909071 · YXLL-2025-083

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗