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.
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.
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
Parallel
Hybrid closed-loop insulin delivery system
DevicePerioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.
conventional insulin pumps combined with CGM
DevicePerioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.
CGM-measured Time in Range (TIR 5.6-10.0 mmol/L)
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.
Time above range (TAR) >10.0 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \> 10.0 mmol/L between group
Time above range (TAR) >20.0 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \> 20.0 mmol/L between group
Time below range (TBR) <5.6 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \<5.6 mmol/L between groups
Time below range (TBR) < 3.9 mmol/L
The difference in the CGM-measured percentage of time with sensor glucose values \<3.9 mmol/L between groups
Safety outcomes
Safety outcomes will include the difference in the incidence rates of: (1) perioperative infections, (2) hypoglycemia (Level 1: \<3.9 mmol/L; Level 2: \<3.0 mmol/L; severe: requiring assistance), (3) diabetic ketoacidosis/ketosis, (4) adverse events and device-related adverse events, and (5) all serious adverse events (SAEs), between groups.
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