Fact CheckerSign in

NCT07121504Recruiting

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

Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
22 May 2025
Start date
26 Jun 2025
Primary completion date
1 Jun 2026
Lead sponsor
Second Xiangya Hospital of Central South University
NCT number
NCT07121504

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 26 Jun 2025 to the primary completion date, 1 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have contraindications to conventional insulin pump therapy.
  • Patients who suffer severe surgical complications.

Other illness

  • 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.

Lab values

  • 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.

Other

  • Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.