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

NCT06295289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-05-23

No results posted yet for this study

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

Interventions

DEVICE

Hybrid Closed-loop Insulin Delivery System

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.

DEVICE

Insulin pump

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.

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2024-12-04
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06295289 on ClinicalTrials.gov