NCT07121504

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

Effect of Hybrid Closed-Loop Insulin Delivery System on Glycemic Management in Perioperative Patients With Type 2 Diabetes Receiving Parenteral Nutrition: An Open-Label, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Hybrid closed-loop insulin delivery system	Perioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.
DEVICE	conventional insulin pumps combined with CGM	Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.

Timeline

• Start date: 2025-06-26
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: China