Hybrid closed-loop insulin control for surgical patients on short-term parenteral nutrition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, open-label, randomized 1:1 trial in Changsha compares hybrid closed-loop insulin delivery to open-loop pump therapy paired with continuous glucose monitoring in adults with type 2 diabetes undergoing surgery and expected short-term total parenteral nutrition. Participants are randomized to use identical hardware either in automated closed-loop mode or in manual open-loop mode for 5–7 days during the perioperative hospitalization. Eligible patients meet glycemic-control thresholds (for example higher HbA1c or elevated random glucose) and the trial excludes type 1 diabetes, acute diabetic crises, and severe organ dysfunction. The study measures glycemic outcomes such as time-in-range, episodes of hypoglycemia and hyperglycemia, and device-related safety events.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Xia Li, MD, PhD — Second Xiangya Hospial of Central South University
• Study coordinator: Xia Li, MD, PhD
• Email: lixia2014@vip.163.com
• Phone: +86 13974885753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.