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

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

Hybrid Closed-loop Insulin Delivery System

Insulin pump

Clinical Study ID

NCT06295289

ZRKY-2023-04

Ages 18-75
All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

1）18~75 years old (including 18 years old and 75 years old),

2）Perioperative patients with need diabetes including type 2 diabetes mellitus and other special types of diabetes mellitus and need insulin therapy;

3）Fasting blood glucose ≥7.0mmol/L or random blood glucose 11.1≥mmol/L;

4）Patients signed the informed consent form and volunteered to participate in the clinical trial.

5 ) Patients who have already undergone surgery and are still hospitalized during the perioperative period with poor glycemic control.

Exclusion

Exclusion Criteria:

The patients were complicated with diabetic emergencies, such as diabeticketoacidosis, diabetic hyperosmolar non-ketotic coma, etc.
Type 1 diabetes mellitus
Patients with severe cardiac and renal organ dysfunction: cardiac function abovegrade III; Serum creatinine over 442μmol/L; Hemoglobin less than 90g/L; White bloodcell 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 coagulationfunction;
Patients who suffer from mental illness, have no self-control, and cannot expressthemselves clearly.
Other circumstances that investigator considered to be inappropriate for clinicaltrial participation;

Patients with severe complications during or after surgery.

Study Design

Hybrid Closed-loop Insulin Delivery System

October 16, 2023

December 31, 2024

Study Description

Hyperglycemia is particularly frequent in the perioperative period, which leads to metabolic and functional disorders, aggravates organ damage, induces various complications, and increases the risk of postoperative infection and even death.

However, glucose level management among perioperative patients remains challenging because of the frequent blood glucose monitoring requirement and insulin adjustment to accommodate the physiological changes of patients before surgery.

In this study, we planned to use an open-source, hybrid closed-loop insulin delivery system and common insulin pump combined with CGM for short-term intensive insulin therapy in patients with diabetes during the perioperative period. To comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop insulin delivery system, we planned to compare the blood glucose control and other clinical indicators such as postoperative complications of patients with different intensive insulin therapy regimens If the participant is enrolled before the surgery, the following procedure will be followed:

Preoperative: the participants wear the open-source AP system for treatment.

Intraoperative: participants should discontinue the insulin pump in advance, with the specific timing determined by the endocrinologist. The CGM can remain in place as long as it does not interfere with the surgery.

Postoperative: After the subject returns to the ward, the nurse will reinstall the open-source AP system, and the treatment will continue for at least 3-4 days.

Connect with a study center

Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430030
China
Site Not Available

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