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Recruiting NCT07121504

Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hybrid closed-loop insulin delivery system, conventional insulin pumps combined with CGM.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Hybrid Closed-Loop Insulin Delivery System on Glycemic Management in Perioperative Patients With Type 2 Diabetes Receiving Parenteral Nutrition: An Open-Label, Randomized Controlled Trial

Overview

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.

Detailed description

This study is a single-center, open-label, 1:1 randomized controlled exploratory trial. Participants were randomly allocated via complete randomization into two groups: the experimental group (hybrid closed-loop insulin delivery system) and the control group (using identical hardware devices, with the experimental group operating in closed-loop mode while the control group in open-loop mode). The intervention duration ranged from 5 to 7 days, adjusted based on glycemic control status, aiming to compare the efficacy and clinical benefits of hybrid closed-loop insulin delivery versus insulin pumps combined with CGM for glycemic management.

Interventions

  • Device Hybrid closed-loop insulin delivery system
    Perioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.
  • Device conventional insulin pumps combined with CGM
    Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.

Primary outcome measures

  • CGM-measured Time in Range (TIR 5.6-10.0 mmol/L) [Time frame: Up to 28 days]
Secondary outcome measures (12)
  • Time above range (TAR) >10.0 mmol/L [Time frame: Up to 28 days]
  • Time above range (TAR) >20.0 mmol/L [Time frame: Up to 28 days]
  • Time below range (TBR) <5.6 mmol/L [Time frame: Up to 28 days]
  • Time below range (TBR) < 3.9 mmol/L [Time frame: Up to 28 days]
  • Time below range (TBR) < 3.0 mmol/L [Time frame: Up to 28 days]
  • Time below range (TBR) < 2.8 mmol/L [Time frame: Up to 28 days]
  • CGM-measured Mean Glucose Level [Time frame: Up to 28 days]
  • CGM-measured Glucose Standard Deviation (SD) [Time frame: Up to 28 days]
  • CGM-Measured Glucose Coefficient of Variation (CV) [Time frame: Up to 28 days]
  • CGM-Measured Glucose Risk Index (GRI) [Time frame: Up to 28 days]
  • Insulin dose [Time frame: Up to 28 days]
  • Preoperative optimization duration (days) [Time frame: Up to 28 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South Univer — Changsha

Identifiers

NCT: NCT07121504 · HCL-T2D 2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗