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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Hybrid Closed-Loop Artificial Pancreas System
DeviceThe 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).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Traditional insulin pump groupPlacebo comparator 1 intervention
Group B: Hybrid Closed-Loop Artificial Pancreas System GroupExperimental treatment 1 intervention
Trial outcomes
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%
Time frame
During the 5- to 7-day period of hospitalizationSecondary outcomes
1
Blood glucose target criteria
FPG (fasting plasma glucose) or pre-prandial blood glucose of 8\~10 mmol/L, 2hPG (2-hour postprandial glucose) or blood glucose at any time point when unable to eat is 8\~12 mmol/L. General criteria: FPG or pre-prandial blood glucose of 6\~8 mmol/L, 2hPG or blood glucose at any time point when unable to eat is 8\~10 mmol/L (Expert Consensus on Perioperative Blood Glucose Monitoring for Adults - 2021) . The blood glucose target achievement rate within 1 week of insulin intensification therapy is calculated using the formula: Blood glucose target achievement rate = Number of patients achieving blood glucose targets / Total number of patients \* 100%.
Time frame
During the 5- to 7-day period of hospitalization2
Time Below Range (TBR)、Time Above Range (TAR)
Time Below Range (TBR) refers to the percentage of time when blood glucose is below the target range, that is, blood glucose \< 3.9 mmol/L. The calculation formula is: TBR = (Time with blood glucose \< 3.9 mmol/L) / Total Time × 100%. Time Above Range (TAR) refers to the percentage of time when blood glucose is above the target range, that is, blood glucose \> 10.0 mmol/L. The calculation formula is: TAR = (Time with blood glucose \> 10.0 mmol/L) / Total Time × 100%.
Time frame
During the 5- to 7-day period of hospitalization3
Hypoglycemia Incidence Rate
Using a blood glucose range of 3.0 - 3.9 mmol/L as the diagnostic criterion for hypoglycemia, the incidence of hypoglycemia during the treatment process in the two groups was counted and compared. Taking a blood glucose level \< 3.0 mmol/L as the diagnostic criterion for severe hypoglycemia, the incidence of severe hypoglycemia during the treatment process in the two groups was also counted and compared.
Time frame
During the 5- to 7-day period of hospitalization4
Blood glucose fluctuation level (IQR)
The 25th and 75th percentile values of the blood glucose fluctuation range
Time frame
During the 5- to 7-day period of hospitalizationSponsors and contacts
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Source ClinicalTrials.gov