Actively Recruiting
Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition
Led by Second Xiangya Hospital of Central South University · Updated on 2025-08-13
40
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of type 2 diabetes mellitus requiring surgery lasting at least 2 hours
- Anticipated short-term total parenteral nutrition during perioperative period with expected hospitalization over 72 hours
- Glycemic control criteria: HbA1c 7.5% or higher, or random plasma glucose 13.9 mmol/L or higher
- T2DM patients with poor glycemic control despite 2 or more oral antidiabetic drugs, or insulin-treated with suboptimal control (HbA1c 7.0% or higher)
- Willingness to sign informed consent form
You will not qualify if you...
- Acute diabetic complications such as diabetic ketoacidosis or hyperglycemic hyperosmolar state
- Type 1 diabetes or other specific diabetes types
- Severe organ dysfunction including cardiac function class III or higher, ALT/AST over 3 times upper limit of normal, eGFR below 30 mL/min/1.73 m²
- Hemoglobin below 90 g/L, white blood cell count below 4.0x10⁹/L, or platelet count below 90x10⁹/L
- Hemodynamic instability
- Endocrine disorders affecting glucose metabolism such as hyperthyroidism, hypothyroidism, or Cushing's syndrome
- Known hypersensitivity to drugs or materials used in the study
- Contraindications to conventional insulin pump therapy
- Dermatological conditions like skin rash or prurigo, or coagulation disorders
- Impaired consciousness or psychiatric disorders affecting decision-making or communication
- Other conditions judged unsuitable by investigators
- Severe surgical complications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011
Changsha, Hunan, China, 410011
Actively Recruiting
Research Team
X
Xia Li, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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