Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT

NCT06909071 | Recruiting

• 1 other identifier: YXLL-2025-083
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we plan to use an open-source hybrid closed-loop artificial pancreas system and a combination of a traditional insulin pump and continuous glucose monitoring (CGM) respectively to conduct short-term intensive insulin treatment for patients with type 2 diabetes mellitus (T2DM) during the perioperative period who are hospitalized in the Department of Neurosurgery of Shanxi Bethune Hospital. By comparing the blood glucose control status of patients under different intensive insulin treatment regimens and other clinical indicators such as postoperative complications, we will comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop artificial pancreas system.

Conditions

T2DM Patients With Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Time in Range (TIR)

  The percentage of time that blood glucose is within the target range of 6.0-12.0 mmol/L. The calculation formula is: TIR = (Time within the target range / Total time) × 100%

  During the 5- to 7-day period of hospitalization

Secondary Outcomes (8)

• Blood glucose target criteria

  During the 5- to 7-day period of hospitalization

• Time Below Range (TBR)、Time Above Range (TAR)

  During the 5- to 7-day period of hospitalization

• Hypoglycemia Incidence Rate

  During the 5- to 7-day period of hospitalization

• Blood glucose fluctuation level (IQR)

  During the 5- to 7-day period of hospitalization

• Perioperative Infection Rate and Inflammatory Markers

  During the 5- to 7-day period of hospitalization

Study Arms (2)

Traditional insulin pump group

PLACEBO COMPARATOR

Based on the patient's weight, the total daily insulin requirement is calculated at 0.3\~0.6U/(kg\*d) and distributed before meals according to the specific conditions of the patient. Continuous glucose monitoring system is used along with daily capillary blood glucose monitoring (fasting, 2 hours after breakfast, lunch, and dinner, totaling 4 times). Insulin doses are adjusted according to the patient's blood glucose level until the target blood glucose level is achieved.

Device: Hybrid Closed-Loop Artificial Pancreas System

Hybrid Closed-Loop Artificial Pancreas System Group

EXPERIMENTAL

The open-source hybrid closed-loop artificial pancreas system, utilizing ultra-rapid-acting insulin, was employed for perioperative blood glucose management in neurosurgery. Insulin requirements were calculated based on patient weight. The system auto-adjusted basal rates according to blood glucose, while bolus treatments were manually inputted by nurses following physician instructions. Continuous and daily capillary blood glucose monitoring were conducted.

Device: Hybrid Closed-Loop Artificial Pancreas System

Interventions

Hybrid Closed-Loop Artificial Pancreas System DEVICE

The total daily insulin requirement is calculated as 0.3 - 0.6 U/(kg·d) according to patient's weight. The system automatically adjusts the basal rate during operation. Nurses enter bolus dose orders in AAPS software as directed by physicians. Blood glucose is monitored via continuous glucose monitoring and 4 daily fingerstick measurements (fasting and 2 hours after each meal).

Hybrid Closed-Loop Artificial Pancreas System Group; Traditional insulin pump 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:

• Aged between 18 and 75 years old.
• Patients who have undergone neurosurgical procedures for intracranial hemorrhage (including subdural hemorrhage, basal ganglia hemorrhage, and subarachnoid hemorrhage), have a Glasgow Coma Scale score of 12 or higher after leaving the intensive care unit, receive enteral nutrition postoperatively, and have a previously established diagnosis of type 2 diabetes mellitus, or meet the diagnostic criteria for type 2 diabetes mellitus in the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes" (2020 edition) .
• Fasting blood glucose ≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L.
• Those who have signed the informed consent form and are willing to participate in this clinical trial voluntarily.

You may not qualify if:

• Patients with diabetic emergencies, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.
• Patients with type 1 diabetes or other special types of diabetes.
• Patients with severe cardiac and renal dysfunction: those with cardiac function above grade III; those with serum creatinine exceeding 442 μmol/L.
• Patients with diseases that affect glucose metabolism, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.
• Patients who are allergic to the drugs involved in the clinical diagnosis and treatment plan.
• Populations and contraindications that are not suitable for insulin pump treatment.
• Patients with allergic constitution and those who are allergic to adhesive tape.
• Patients with skin diseases such as rashes and prurigo, or those with abnormal coagulation function.
• Patients with impaired consciousness or mental diseases, who lack self-control and cannot express themselves clearly.
• Other situations that the researcher deems inappropriate for participating in the clinical trial.
• Patients who develop severe complications during or after surgery and are judged by the researcher as unfit for enrollment.

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

Central Study Contacts

Shiwei Liu, Doctor

CONTACT

+86 13191072733; lswspring6@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)