Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition

Официальное название

Effect of Hybrid Closed-Loop Insulin Delivery System on Glycemic Management in Perioperative Patients With Type 2 Diabetes Receiving Parenteral Nutrition: An Open-Label, Randomized Controlled Trial

Обзор

Glycemic control in surgical patients with type 2 diabetes mellitus (T2DM) receiving parenteral nutrition represents a major clinical challenge. This randomized controlled trial evaluates the comparative effectiveness and safety of hybrid closed-loop (HCL) insulin delivery versus conventional insulin pumps combined with continuous glucose monitoring (CGM) in perioperative T2DM patients requiring short-term parenteral nutrition.

Подробное описание

This study is a single-center, open-label, 1:1 randomized controlled exploratory trial. Participants were randomly allocated via complete randomization into two groups: the experimental group (hybrid closed-loop insulin delivery system) and the control group (using identical hardware devices, with the experimental group operating in closed-loop mode while the control group in open-loop mode). The intervention duration ranged from 5 to 7 days, adjusted based on glycemic control status, aiming to compare the efficacy and clinical benefits of hybrid closed-loop insulin delivery versus insulin pumps combined with CGM for glycemic management.

Вмешательства

• Устройство Hybrid closed-loop insulin delivery system
  Perioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.
• Устройство conventional insulin pumps combined with CGM
  Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.

Первичные конечные точки

• CGM-measured Time in Range (TIR 5.6-10.0 mmol/L) [Срок оценки: Up to 28 days]

Вторичные конечные точки (12)

• Time above range (TAR) >10.0 mmol/L [Срок оценки: Up to 28 days]
• Time above range (TAR) >20.0 mmol/L [Срок оценки: Up to 28 days]
• Time below range (TBR) <5.6 mmol/L [Срок оценки: Up to 28 days]
• Time below range (TBR) < 3.9 mmol/L [Срок оценки: Up to 28 days]
• Time below range (TBR) < 3.0 mmol/L [Срок оценки: Up to 28 days]
• Time below range (TBR) < 2.8 mmol/L [Срок оценки: Up to 28 days]
• CGM-measured Mean Glucose Level [Срок оценки: Up to 28 days]
• CGM-measured Glucose Standard Deviation (SD) [Срок оценки: Up to 28 days]
• CGM-Measured Glucose Coefficient of Variation (CV) [Срок оценки: Up to 28 days]
• CGM-Measured Glucose Risk Index (GRI) [Срок оценки: Up to 28 days]
• Insulin dose [Срок оценки: Up to 28 days]
• Preoperative optimization duration (days) [Срок оценки: Up to 28 days]

Критерии участия

Критерии включения

• Age ≥18 years.
• Diagnosis of T2DM requiring surgical procedures (duration ≥2 hours) with anticipated short-term total parenteral nutrition (TPN) during the perioperative period (expected hospitalization >72 hours).
• Glycemic control criteria (meeting any of the following):

①HbA1c ≥7.5% or random plasma glucose ≥13.9 mmol/L

• Established T2DM with poor glycemic control (HbA1c ≥7.5%) despite combination therapy (≥2 oral antidiabetic drugs) ③Insulin-treated patients with suboptimal control (HbA1c ≥7.0%) after adequate dose adjustment.
• Willing to sign the informed consent form.

Критерии исключения

• Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.
• Patients with type 1 diabetes or other specific types of diabetes.
• Patients with severe organ dysfunction, defined as:

• Cardiac function ≥Class III (NYHA classification)

• ALT/AST >3× upper limit of normal (ULN) ③ eGFR ≤30 mL/min/1.73 m²

• Hemoglobin <90 g/L ⑤ WBC count <4.0×10⁹/L or platelets <90×10⁹/L ⑥ Hemodynamic instability
• Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
• Patients with known hypersensitivity to any drugs or materials used in the study protocol.
• Patients who have contraindications to conventional insulin pump therapy.
• Patients with dermatological conditions (e.g., skin rash, prurigo) or coagulation disorders.
• Patients with impaired consciousness or psychiatric disorders affecting decision-making capacity or communication ability.
• Patients who have other conditions deemed unsuitable for trial participation by investigators.
• Patients who suffer severe surgical complications.

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

Лечение

Центры проведения

Китай · 1 центр

• Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South Univer — Чанша

Идентификаторы

NCT: NCT07121504 · HCL-T2D 2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗