Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial

NCT06295289 | Completed

• 1 other identifier: ZRKY-2023-04
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• TIR

  time in range

  5-10days

Secondary Outcomes (3)

• TAR

  5-10days

• TBR

  5-10days

• MBG

  5-10days

Other Outcomes (1)

• postoperative infection

  5-10days

Study Arms (2)

Hybrid closed-loop insulin delivery system group

EXPERIMENTAL

After patients signed the informed consent form in the ward, the nurse installed the insulin pump and the subcutaneous, real-time, continuous glucose monitor (CGM). The insulin pump was installed in the abdomen or upper arm, and the CGM was installed in the upper arm. A Hybrid closed-loop insulin delivery system with an open-source algorithm was set up for participants by the clinical trial investigators. The algorithm was initialized with the participant's weight and basal insulin requirements. The control algorithm modulated insulin delivery every 5 min based on the CGM glucose level, anticipated glucose trends, and patient-specific information such as the basal rate profile to guarantee blood glucose control within the target range. The perioperative patients in the hybrid closed-loop insulin delivery group who were admitted to the hospital received 3-5 days of glucose-lowering therapy.

Device: Hybrid Closed-loop Insulin Delivery System

Insulin pump therapy group (Control group)

PLACEBO COMPARATOR

The insulin treatment with a pump and CGM was applied according to the local clinical guidelines. The insulin pump was installed in the abdomen or upper arm, and the CGM was inserted in the upper arm by the investigator. Doctors adjust the insulin dose according to the patient's glucose level.

Device: Insulin pump

Interventions

Hybrid Closed-loop Insulin Delivery System DEVICE

The Hybrid Closed-loop Insulin Delivery System system consisted of a Medtronic pump, a continuous glucose monitoring system（SIBIONICS®）and an open-source algorithm integrated into the phone. Insulin pump therapy group consisted of a Medtronic pump, and a continuous glucose monitoring system（SIBIONICS®). The difference between the two groups is that the artificial pancreas system automatically regulates the basal rate to maintain blood glucose in a target range.

Hybrid closed-loop insulin delivery system group

Insulin pump DEVICE

Participants used conventional insulin pumps to control blood glucose, At the same time, a continuous glucose monitoring system was used to monitor glucose changes. Health care providers adjust the insulin dose of patients according to their blood glucose level.

Insulin pump therapy group (Control group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）18\~75 years old (including 18 years old and 75 years old),
• ）Perioperative patients with need diabetes including type 2 diabetes mellitus and other special types of diabetes mellitus and need insulin therapy;
• ）Fasting blood glucose ≥7.0mmol/L or random blood glucose 11.1≥mmol/L;
• ）Patients signed the informed consent form and volunteered to participate in the clinical trial.
• ) Patients who have already undergone surgery and are still hospitalized during the perioperative period with poor glycemic control.

You may not qualify if:

• The patients were complicated with diabetic emergencies, such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma, etc.
• Type 1 diabetes mellitus
• Patients with severe cardiac and renal organ dysfunction: cardiac function above grade III; Serum creatinine over 442μmol/L; Hemoglobin less than 90g/L; White blood cell count \<4.0×109/L or platelet count \<90×109/L;
• Patients who are allergic to drugs specified in clinical protocols
• Patients who are not suitable for conventional insulin pump therapy.
• Patients who are allergic constitution and allergic to tape
• Patients with skin diseases such as rash and prurigo, or abnormal coagulation function;
• Patients who suffer from mental illness, have no self-control, and cannot express themselves clearly.
• Other circumstances that investigator considered to be inappropriate for clinical trial participation;
• \) Patients with severe complications during or after surgery.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

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, Chief Physician，Director of Department of Endocrinology

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: October 16, 2023
• Primary Completion: December 4, 2024
• Study Completion: December 31, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)