Status:
RECRUITING
Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT
Lead Sponsor:
Shanxi Bethune Hospital
Conditions:
T2DM Patients With Traumatic Brain Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
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 condu...
Detailed Description
According to the inclusion and exclusion criteria, 40 perioperative patients with type 2 diabetes mellitus (T2DM) will be screened and enrolled from the neurosurgical ward of Shanxi Bethune Hospital. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06909071
Start Date
April 15 2025
End Date
August 31 2027
Last Update
April 23 2025
Active Locations (1)
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1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000