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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.
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. They will be randomly divided into two groups: 20 patients in the hybrid closed-loop artificial pancreas system group and 20 patients in the traditional pump combined with continuous glucose monitoring (CGM) group. Both groups of patients will use continuous glucose monitoring to measure blood glucose levels. After collecting baseline data, the two groups of patients will receive short-term intensive insulin therapy according to the above-mentioned plans. Relevant clinical data will be collected during and after the treatment to compare the advantages and disadvantages of the two intensive insulin treatment plans in controlling blood glucose levels in perioperative T2DM patients undergoing neurosurgery and their impact on complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiwei Liu, Doctor | Contact | +86 13191072733 | 0351-2170956 | lswspring6@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Bethune Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
If there is a need to use data, please contact the person in charge and follow the relevant procedures to achieve data sharing. Without permission, do not use the data directly.
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| During the 5- to 7-day period of hospitalization |
| 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%. | During the 5- to 7-day period of hospitalization |
| 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. | During the 5- to 7-day period of hospitalization |
| Blood glucose fluctuation level (IQR) | The 25th and 75th percentile values of the blood glucose fluctuation range | During the 5- to 7-day period of hospitalization |
| Perioperative Infection Rate and Inflammatory Markers | The percentage of patients with fever, positive bacterial culture of incision secretions, other secretions or blood during the perioperative period, calculated as (Number of patients with positive results / Total number of patients) × 100%. Perioperative inflammatory indicators include white blood cell count (WBC), percentage of neutrophils, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), procalcitonin, etc. | During the 5- to 7-day period of hospitalization |
| Adverse event(AE)、Serious adverse event(SAE) | Adverse events are defined as any unfavorable medical events that occur during the use of the investigational medical device, regardless of whether they are related to the device. Serious adverse events are defined as events that result in death or a serious deterioration of the health status during the clinical trial. The incidences of adverse events and serious adverse events during the treatment process in the three groups were statistically analyzed and compared. | During the 5- to 7-day period of hospitalization |
| Perioperative infection rate and inflammatory markers | The perioperative infection rate is calculated as the number of patients who develop fever, have incision secretions, positive bacterial cultures from other secretions or blood during the perioperative period divided by the total number of patients, multiplied by 100%. Perioperative inflammatory markers include white blood cell count (WBC), percentage of neutrophils, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), procalcitonin, etc. | During the 5- to 7-day period of hospitalization |
| Suture removal time, total hospital stay days, and postoperative hospital stay days | Suture removal time, total hospital stay days, and postoperative hospital stay days | During the 5- to 7-day period of hospitalization |