Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition
NCT ID: NCT07121504
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-06-26
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hybrid closed-loop insulin delivery system
T2DM patients in the experimental group will receive the hybrid closed-loop insulin delivery system.
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 pump with CGM
T2DM patients in the control group will receive conventional insulin pump therapy with CGM.
conventional insulin pumps combined with CGM
Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Second Xiangya Hospital of Central South University
OTHER
Responsible Party
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Xia Li
Professor
Principal Investigators
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Xia Li, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Xiangya Hospial of Central South University
Locations
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Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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HCL-T2D 2025
Identifier Type: -
Identifier Source: org_study_id
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