Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanxi Bethune Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hybrid Closed-Loop Artificial Pancreas System
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov