Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition
Recruiting · NCT07121504 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Xiangya Hospital of Central South University
View the official record on ClinicalTrials.gov →Interventions studied
Hybrid closed-loop insulin delivery systemconventional insulin pumps combined with CGM
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.
- Patients with type 1 diabetes or other specific types of diabetes.
- 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.
- Patients with known hypersensitivity to any drugs or materials used in the study protocol.
- Patients who have contraindications to conventional insulin pump therapy.
- 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.
- Patients who suffer severe surgical complications.
Where it is running
1 location listed.
- Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011 - Changsha, Hunan, China