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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

Qualifiers

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).

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.

Disqualifiers

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.

Cardiac function ≥Class III (NYHA classification)

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

Trial design

Treatments tested in this trial

  • Hybrid closed-loop insulin delivery system
  • conventional insulin pumps combined with CGM

Treatment groups

40 Participants
are divided into 2 treatment groups