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

NCT07121504 | Recruiting DMC

• 1 other identifier: HCL-T2D 2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

hybrid closed-loop; perioperative; parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• CGM-measured Time in Range (TIR 5.6-10.0 mmol/L)

  The difference in percentage of time spent within target glucose range (5.6-10.0 mmol/L) between groups, as continuously monitored by a CGM device, to evaluate the effectiveness of hybrid closed-loop insulin delivery versus control in improving glycemic control for perioperative T2DM patients receiving parenteral nutrition.

  Up to 28 days

Secondary Outcomes (13)

• Time above range (TAR) >10.0 mmol/L

  Up to 28 days

• Time above range (TAR) >20.0 mmol/L

  Up to 28 days

• Time below range (TBR) <5.6 mmol/L

  Up to 28 days

• Time below range (TBR) < 3.9 mmol/L

  Up to 28 days

• Time below range (TBR) < 3.0 mmol/L

  Up to 28 days

Other Outcomes (1)

• Safety outcomes

  Up to 28 days

Study Arms (2)

Hybrid closed-loop insulin delivery system

EXPERIMENTAL

T2DM patients in the experimental group will receive the hybrid closed-loop insulin delivery system.

Device: Hybrid closed-loop insulin delivery system

Conventional insulin pump with CGM

ACTIVE COMPARATOR

T2DM patients in the control group will receive conventional insulin pump therapy with CGM.

Device: conventional insulin pumps combined with CGM

Interventions

Hybrid closed-loop insulin delivery system DEVICE

Perioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.

Hybrid closed-loop insulin delivery system

conventional insulin pumps combined with CGM DEVICE

Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.

Conventional insulin pump with CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperphagia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Xia Li, MD, PhD

  Second Xiangya Hospial of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia Li, MD, PhD

CONTACT

+86 13974885753; lixia2014@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: August 13, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)