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

Central South University

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Device: Hybrid closed-loop insulin delivery system; Device: conventional insulin pumps combined with CGM

Study type: Interventional

Funder types: Other

Identifiers

NCT07121504

HCL-T2D 2025

Details and patient eligibility

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Hybrid closed-loop insulin delivery system

Experimental group

Description:

T2DM patients in the experimental group will receive the hybrid closed-loop insulin delivery system.

Treatment:

Device: Hybrid closed-loop insulin delivery system

Conventional insulin pump with CGM

Active Comparator group

Description:

T2DM patients in the control group will receive conventional insulin pump therapy with CGM.

Treatment:

Device: conventional insulin pumps combined with CGM