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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CGM-measured Time in Range (TIR 5.6-10.0 mmol/L)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hybrid closed-loop insulin delivery system
T2DM patients in the experimental group will receive the hybrid closed-loop insulin delivery system.
干预措施: Hybrid closed-loop insulin delivery system (Device)
Conventional insulin pump with CGM
T2DM patients in the control group will receive conventional insulin pump therapy with CGM.
干预措施: conventional insulin pumps combined with CGM (Device)
结局指标
主要结局
CGM-measured Time in Range (TIR 5.6-10.0 mmol/L)
时间窗: Up to 28 days
The difference in percentage of time spent within target glucose range (5.6-10.0 mmol/L) between groups, as continuously monitored by a CGM device, to evaluate the effectiveness of hybrid closed-loop insulin delivery versus control in improving glycemic control for perioperative T2DM patients receiving parenteral nutrition.
次要结局
- Time below range (TBR) < 3.9 mmol/L(Up to 28 days)
- Time below range (TBR) < 3.0 mmol/L(Up to 28 days)
- CGM-measured Mean Glucose Level(Up to 28 days)
- Time below range (TBR) <5.6 mmol/L(Up to 28 days)
- Time above range (TAR) >10.0 mmol/L(Up to 28 days)
- Time above range (TAR) >20.0 mmol/L(Up to 28 days)
- Time below range (TBR) < 2.8 mmol/L(Up to 28 days)
- CGM-measured Glucose Standard Deviation (SD)(Up to 28 days)
- CGM-Measured Glucose Coefficient of Variation (CV)(Up to 28 days)
- CGM-Measured Glucose Risk Index (GRI)(Up to 28 days)
- Insulin dose(Up to 28 days)
- Preoperative optimization duration (days)(Up to 28 days)
- Time in range (TIR) 4.4-10.0 mmol/L(Up to 28 days)
研究者
Xia Li
Professor
Second Xiangya Hospital of Central South University