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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295289
• Other study ID #: ZRKY-2023-04
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: December 4, 2024

Study information

• Verified date: August 2023
• Source: Huazhong University of Science and Technology
• Contact: Xuefeng Yu
• Phone: 02783662883
• Email: xfyu188[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 4, 2024
• Est. primary completion date: October 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Exclusion Criteria:

1. The patients were complicated with diabetic emergencies, such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma, etc.

2. Type 1 diabetes mellitus

3. 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;

4. Patients had used glucocorticoids for more than 1 week or were currently using glucocorticoids within 1 month before screening

5. Patients who are allergic to drugs specified in clinical protocols

6. Patients who are not suitable for conventional insulin pump therapy.

7. Patients who are allergic constitution and allergic to tape

8. Patients with skin diseases such as rash and prurigo, or abnormal coagulation function;

9. Patients who suffer from mental illness, have no self-control, and cannot express themselves clearly.

10. Other circumstances that investigator considered to be inappropriate for clinical trial participation;

11) Patients with severe complications during or after surgery.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative infection	rate of postoperative infection in the perioperative period	5-10days
Primary	TIR	time in range	5-10days
Secondary	TAR	time above range	5-10days
Secondary	TBR	time blow range	5-10days
Secondary	MBG	mean blood glucose	5-10days