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Clinical Trials in China / NCT07121504
Recruiting Not applicable

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

NCT07121504 · tracked via the Priya Life Science China tracker
Sponsor
Second Xiangya Hospital of Central South University
Phase
Not applicable
Started
2025-06-26
Last updated
2025-08-13

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

Hybrid closed-loop insulin delivery systemconventional insulin pumps combined with CGM

Hybrid closed-loop insulin delivery system: Perioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.

conventional insulin pumps combined with CGM: Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011 Changsha Hunan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07121504 on ClinicalTrials.gov ↗ ← All trials in China