NCT07121504 Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition
| NCT ID | NCT07121504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-26 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-06-26 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Xia Li, MD, PhD
PRINCIPAL INVESTIGATOR
Second Xiangya Hospial of Central South University
Frequently Asked Questions
Who can join the NCT07121504 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07121504 currently recruiting?
Yes, NCT07121504 is actively recruiting participants. Contact the research team at lixia2014@vip.163.com for enrollment information.
Where is the NCT07121504 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT07121504 clinical trial?
NCT07121504 is sponsored by Second Xiangya Hospital of Central South University. The principal investigator is Xia Li, MD, PhD at Second Xiangya Hospial of Central South University. The trial plans to enroll 40 participants.
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