Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- ALT/AST >3× upper limit of normal (ULN) ③ eGFR ≤30 mL/min/1.73 m²
- Cardiac function ≥Class III (NYHA classification)
- 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.