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

Sponsored by Second Xiangya Hospital of Central South University

About this trial

Last updated 9 months ago

Study ID

HCL-T2D 2025

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started a year ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

1. Age ≥18 years.

2. 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).

3. 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.

4. Willing to sign the informed consent form.

Exclusion Criteria

1. Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.

2. Patients with type 1 diabetes or other specific types of diabetes.

3. 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

4. Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.

5. Patients with known hypersensitivity to any drugs or materials used in the study protocol.

6. Patients who have contraindications to conventional insulin pump therapy.

7. Patients with dermatological conditions (e.g., skin rash, prurigo) or coagulation disorders.

8. Patients with impaired consciousness or psychiatric disorders affecting decision-making capacity or communication ability.

9. Patients who have other conditions deemed unsuitable for trial participation by investigators.

10. Patients who suffer severe surgical complications.