Actively Recruiting
Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT
Led by Shanxi Bethune Hospital · Updated on 2025-04-23
40
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years old
- Underwent neurosurgical procedures for intracranial hemorrhage with Glasgow Coma Scale score of 12 or higher after ICU
- Receiving enteral nutrition postoperatively
- Have a diagnosis of type 2 diabetes mellitus or meet diagnostic criteria per Chinese guidelines (2020 edition)
- Fasting blood glucose ≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L
- Signed informed consent and willing to participate voluntarily
You will not qualify if you...
- Diabetic emergencies such as diabetic ketoacidosis or hyperglycemic hyperosmolar coma
- Type 1 diabetes or other special types of diabetes
- Severe cardiac dysfunction above grade III or serum creatinine > 442 µmol/L
- Diseases affecting glucose metabolism like hyperthyroidism, hypothyroidism, or Cushing's syndrome
- Allergic to drugs used in clinical diagnosis or treatment
- Contraindications for insulin pump treatment
- Allergic constitution or allergy to adhesive tape
- Skin diseases such as rashes or prurigo, or abnormal coagulation
- Impaired consciousness or mental diseases preventing self-expression
- Severe complications during or after surgery judged unfit by researcher
- Other situations deemed inappropriate by the researcher for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
Research Team
S
Shiwei Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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