Automated Insulin Device Tested for Blood Sugar Control During Surgery in Type 2 Diabetes
Tests an automated insulin device in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition
Key facts
- Where
- Changsha, ChinaSee the site
Where in China
- Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011Changsha, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Xiangya Hospital of Central South University
- Trial code
- NCT07121504
- Record updated
- 13 August 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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); 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; Willing to sign the informed consent form.
Exclusion: Patients who have contraindications to conventional insulin pump therapy; Patients who suffer severe surgical complications; Patients with type 1 diabetes or other specific types of diabetes; Patients with known hypersensitivity to any drugs or materials used in the study protocol; Patients with dermatological conditions (e.g., skin rash, prurigo) or coagulation disorders; Patients with impaired consciousness or psychiatric disorders affecting decision-making capacity or communication ability; Patients who have other conditions deemed unsuitable for trial participation by investigators; 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; Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc; Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.