Blood dialysis liquid regulation and control method for blood sugar concentration balance

Abstract

The invention relates to the technical field of hemodialysis, in particular to a hemodialysis liquid regulation and control method for blood glucose concentration balance, which specifically comprises the following steps: acquiring an initial insulin sensitivity index of a patient before dialysis; setting a blood glucose threshold interval and a dialysate flow velocity interval; the blood sugar concentration of the patient is monitored in real time in the dialysis process; matching the real-time blood glucose concentration with the blood glucose threshold interval to determine a corresponding dialysate flow velocity interval; performing dynamic adjustment on the basis of the real-time blood glucose concentration; the blood glucose concentration is pre-judged based on the real-time blood glucose concentration, so that the type and the flow velocity of dialysate are regulated and controlled; therefore, in the hemodialysis process, different patients can be more accurately adapted, and accurate regulation and control of the blood sugar concentration can be achieved.

Description

A method for regulating hemodialysis fluids to maintain blood glucose concentration balance Technical Field

[0001] This application relates to the field of hemodialysis technology, and in particular to a method for regulating hemodialysis fluid for blood glucose concentration balancing. Background Technology

[0002] Hemodialysis is a core treatment for end-stage renal disease patients, and maintaining blood glucose balance during treatment directly affects dialysis safety and long-term patient prognosis. During dialysis, glucose diffuses freely across the dialysis membrane, and improper dialysate glucose concentration or flow rate settings can easily lead to hypoglycemia or hyperglycemia. Hypoglycemia is a common complication of dialysis, not only inducing low blood pressure, leading to cerebral hypoxia and increased risk of cardiovascular events, but also interfering with ultrafiltration rate stability and reducing dialysis adequacy. Conversely, excessive glucose supplementation leading to hyperglycemia can increase the metabolic burden on patients, especially those with diabetic nephropathy, potentially exacerbating pancreatic dysfunction. Therefore, precise control of blood glucose concentration balance during hemodialysis helps ensure dialysis safety, improve patient tolerance, and optimize the quality of life for end-stage renal disease patients.

[0003] Several technological studies have addressed the issue of blood glucose imbalance during dialysis. For example, patent CN119909250B describes a method that switches from glucose-free to glucose-containing dialysate when a patient experiences hypoglycemia-induced hypotension. Based on real-time blood glucose concentration, and according to preset first and second hypoglycemia concentration thresholds, it divides the dialysate flow rate into high, medium, and low ranges. Simultaneously, it constructs an osmotic pressure compensation model, an ultrafiltration rate compensation model, and a glucose kinetic equation, using an objective optimization function to solve for the optimal dialysate flow rate, achieving a preliminary balance between hypoglycemia compensation and ultrafiltration rate stability. However, it does not differentiate between patients' insulin sensitivity. Clinically, patients with high insulin sensitivity require only a small amount of glucose to quickly raise their blood glucose. Using a uniform high flow rate mode can easily lead to excessive glucose supply, increasing the risk of hyperglycemia. Conversely, patients with low insulin sensitivity have a slow glucose metabolism rate, making glucose supply inefficient under a uniform medium-low flow rate mode, failing to effectively correct hypoglycemia and resulting in persistent hypotension.

[0004] Patent publication US2022 / 0370695A1 proposes a dialysis system based on continuous glucose monitoring. This system records the patient's blood glucose fluctuations in real time using sensors and, combined with information such as the patient's body composition and plasma volume, adaptively adjusts parameters such as dialysate glucose concentration and ultrafiltration rate. It can also assist in blood glucose regulation through insulin pump administration, further improving the timeliness of blood glucose control. However, it does not incorporate insulin sensitivity as a core basis for parameter adjustment, relying solely on blood glucose value feedback for regulation. This fails to fundamentally adapt to the different metabolic capacities of different patients, and thus cannot avoid the problems of over- or under-correction of blood glucose.

[0005] Both of the above approaches revolve around the coordinated regulation of blood glucose concentration and dialysis parameters, which reduces the incidence of hypoglycemia and hypotension to some extent. However, neither approach achieves precise adaptation to the individual metabolic characteristics of patients, directly leading to a higher blood glucose fluctuation coefficient, interference with ultrafiltration rate stability, and decreased patient tolerance to treatment during clinical dialysis. Summary of the Invention

[0006] In order to more accurately adapt to different patients during hemodialysis and achieve precise control of blood glucose concentration, and reduce the possibility of risks caused by unstable blood glucose during hemodialysis, this application provides a method for controlling hemodialysis fluid for blood glucose concentration balance.

[0007] The method for regulating hemodialysis fluid for blood glucose concentration balance provided in this application adopts the following technical solution.

[0008] A method for regulating hemodialysis fluid for blood glucose concentration balance includes the following steps.

[0009] S1. Obtain the patient's initial insulin sensitivity index before dialysis. ;

[0010] S2, based on Set blood glucose threshold ranges and dialysate flow rate ranges;

[0011] S3. Real-time monitoring of patient blood glucose concentration during dialysis;

[0012] S4. Match the real-time blood glucose concentration with the blood glucose threshold range to determine the corresponding dialysate flow rate range;

[0013] S5, Based on real-time blood glucose concentration Make dynamic adjustments to obtain ;

[0014] S6, based on real-time blood glucose concentration and Predicting blood glucose concentration allows for the adjustment of dialysate type and flow rate.

[0015] Optionally, in step S1, a preset dose of glucose solution is injected into the patient before dialysis, and the rate of change in the patient's blood glucose concentration is monitored within a predetermined time after injection. The result is calculated based on the rate of change in blood glucose concentration. .

[0016] By adopting the above technical solution, the limitations of traditional uniform parameter regulation are broken. It can make precise regulation based on the differences in patients' insulin sensitivity, accurately distinguish the insulin metabolism capacity of different patients, and provide a quantitative basis for subsequent personalized parameter setting. It solves the problem that traditional solutions cannot formulate regulation strategies for patients' metabolic differences.

[0017] Optionally, in S2, for Set high-sensitivity and low-sensitivity thresholds; the blood glucose threshold range is based on... Adjustments are made to the comparison between the high sensitivity threshold and the low sensitivity threshold.

[0018] Optionally, the blood glucose threshold range includes a first blood glucose concentration threshold and a second blood glucose concentration threshold, wherein the second blood glucose concentration threshold is greater than the first blood glucose concentration threshold.

[0019] Optionally, the When the blood glucose concentration exceeds the high sensitivity threshold, the first blood glucose concentration threshold is 80 mg / dL, and the second blood glucose concentration threshold is 90 mg / dL.

[0020] When the blood glucose concentration is between the high sensitivity threshold and the low sensitivity threshold, the first blood glucose concentration threshold is 70 mg / dL and the second blood glucose concentration threshold is 85 mg / dL.

[0021] When the blood glucose concentration is below the low sensitivity threshold, the first blood glucose concentration threshold is 60 mg / dL and the second blood glucose concentration threshold is 85 mg / dL.

[0022] Optionally, the dialysate flow rate range includes a high flow rate range, a medium flow rate range, and a low flow rate range.

[0023] Optionally, the When the flow rate is above the high sensitivity threshold, the high flow rate range is 500-700 ml / min, the medium flow rate range is 350-500 ml / min, and the low flow rate range is 150-300 ml / min.

[0024] When the flow rate is between the high and low sensitivity thresholds, the high flow rate range is 500-800 ml / min, the medium flow rate range is 300-500 ml / min, and the low flow rate range is 100-300 ml / min.

[0025] When the flow rate is below the low sensitivity threshold, the high flow rate range is 600-850 ml / min, the medium flow rate range is 400-600 ml / min, and the low flow rate range is 200-400 ml / min.

[0026] By adopting the above technical solution, high, medium and low sensitivity groups were formed, and differentiated blood glucose threshold ranges and dialysate flow rate ranges were set in a targeted manner, which achieved stratified and precise blood glucose supplementation control and perfectly adapted to the differences in insulin sensitivity of different patients.

[0027] Setting a higher first blood glucose threshold and a lower upper limit for the high flow rate zone for the high-sensitivity group can effectively avoid the risk of hyperglycemia caused by excessive glucose supplementation;

[0028] Setting a lower first blood glucose threshold and a higher upper limit for the high flow rate zone for the low-sensitivity group, while increasing the second blood glucose threshold, can prolong the duration of glucose supplementation and ensure rapid correction of hypoglycemia.

[0029] For the moderately sensitive group, standard parameters are used to balance clinical universality and control precision, covering the treatment needs of most patients;

[0030] By clearly distinguishing between high, medium, and low dialysate flow rate ranges and combining them with stratified blood glucose threshold settings, a linkage response mechanism between blood glucose concentration and flow rate ranges is formed, ensuring the timeliness and adaptability of dialysate flow rate adjustment and further optimizing ultrafiltration rate stability.

[0031] Optionally, in S5 Based on initial insulin sensitivity index Sensitivity correction coefficient Real-time blood glucose concentration Fasting blood glucose concentration before dialysis Calculated based on The relationship between the high-sensitivity threshold and the low-sensitivity threshold is obtained.

[0032] Optionally, in step S6, the blood glucose concentration is predicted. based on Blood glucose rate of change , Predicted duration and trend weighting factor Calculated based on and blood sugar fluctuation range Obtained through calculation.

[0033] Optionally, in S6 if Above the high sensitivity threshold, At mg / dL, the dialysate enters the high flow rate range; When the concentration is mg / dL, reduce the dialysate rate or switch to glucose-free dialysate;

[0034] like Located between the high sensitivity threshold and the low sensitivity threshold, in At mg / dL, the dialysate enters the high flow rate range; When the concentration is mg / dL, decrease the rate of action;

[0035] like Below the low sensitivity threshold, At a concentration of mg / dL, the dialysate enters the high-flow-rate range, simultaneously increasing the glucose concentration in the dialysate to 250 mg / dL; When the concentration is mg / dL, the rate is reduced.

[0036] By adopting the above technical solution, the dynamic changes in the patient's insulin sensitivity during dialysis can be adapted in real time, solving the problem that preoperative static assessment cannot cope with the fluctuations in the patient's physical condition during the operation, and improving the flexibility and timeliness of the control plan.

[0037] Predicting blood glucose concentration enables early intervention for blood glucose abnormalities, eliminating the lag defect of traditional methods that address abnormalities first and then regulate them, thus fundamentally reducing the probability of severe hypoglycemia and hyperglycemia.

[0038] Differentiated predictive intervention strategies were developed for different sensitivity groups, especially for the low-sensitivity group. At a concentration of mg / dL, the high-flow-rate mode and the dialysate glucose concentration were simultaneously triggered to 250 mg / dL, avoiding fatal complications such as hypotension caused by severe hypoglycemia. The intervention thresholds for each group were refined to ensure the targeted nature of the regulatory actions and significantly improve the stability of blood glucose balance.

[0039] In summary, this application includes at least the following beneficial effects.

[0040] This method enables individualized blood glucose regulation, stratified precise control, and dynamic prediction and optimization of blood glucose concentration. It forms a closed-loop management system covering the entire process from preoperative basic assessment to intraoperative stratified control and dynamic prediction intervention. Ultimately, it achieves a precise, stable, and safe balance of blood glucose concentration during hemodialysis, effectively solving the problems of poor individual adaptability, lagging control, and prominent safety hazards of traditional control methods. It significantly reduces the incidence of hyperglycemia, persistent hypoglycemia, and related hypotension, and improves the safety and tolerability of dialysis treatment for patients. Attached Figure Description

[0041] Figure 1 is a flowchart of the main steps of this application. Detailed Implementation

[0042] The present application will be further described in detail below with reference to the accompanying drawings.

[0043] This application discloses a method for regulating hemodialysis fluid for blood glucose concentration balance, referring to Figure 1, and specifically includes the following steps.

[0044] S1. Obtain the patient's initial insulin sensitivity index before dialysis. .

[0045] Fifteen minutes before the start of dialysis treatment, the patient undergoes a SIST trial to circumvent the patent risks associated with certain drugs. Short-acting insulin or its analogues, such as insulin aspart or insulin lispro, are administered intravenously at a dose of 0.05 U / kg, calculated based on the patient's actual weight.

[0046] In this embodiment, venous blood samples were collected from the patient immediately after injection, and at 3, 6 and 12 minutes after injection to measure the blood glucose concentration at the corresponding time points, in mg / dL.

[0047] During the test, the patient's blood pressure and heart rate were continuously monitored. If the blood glucose concentration was below 70 mg / dL at the 6th minute, the test was terminated immediately, and 10 mL of 5% glucose solution was administered intravenously to avoid the risk of preoperative hypoglycemia.

[0048] In order to obtain The rate of blood sugar decrease needs to be measured first. The calculation, A higher value indicates higher insulin sensitivity, meaning that only a small amount of insulin is needed to quickly lower blood sugar. The slope of the 0-12 minute blood glucose concentration-time curve was fitted using the least squares method, as shown in the following formula.

[0049] ;

[0050] in, In this embodiment, the total number of sampling points is [number]. The value is 4. For the first Each sampling point has a value of 0, 3, 6, or 12. For the first The blood glucose concentration corresponding to each sampling time point is expressed in mg / dL and is obtained from venous blood sample testing.

[0051] The calculation formula is as follows.

[0052] ;

[0053] in, The fasting blood glucose concentration before dialysis, expressed in mg / dL, can be obtained by testing one day before dialysis.

[0054] S2, based on Set the blood glucose threshold range and the dialysate flow rate range.

[0055] Set high and low sensitivity thresholds, and adjust them according to the patient's condition. Group them. Those exceeding the high sensitivity threshold are classified as the high sensitivity group. The group with sensitivity between the high and low sensitivity thresholds is the medium sensitivity group. Those below the low sensitivity threshold are classified as the low sensitivity group. The high and low sensitivity thresholds are determined by statistical analysis of large-sample clinical data from end-stage renal disease dialysis patients and verification through prospective trials, combined with reverse derivation of blood glucose control targets to arrive at the optimal cutoff values. In this embodiment, the high sensitivity threshold can be 2.5 and the low sensitivity threshold can be 1.2.

[0056] The blood glucose threshold range includes a first blood glucose concentration threshold and a second blood glucose concentration threshold, with the second blood glucose concentration threshold being greater than the first blood glucose concentration threshold. The dialysate flow rate range includes a high flow rate range, a medium flow rate range, and a low flow rate range. This embodiment is specifically divided as follows.

[0057] For the high-sensitivity group, the first blood glucose concentration threshold was 80 mg / dL, the second blood glucose concentration threshold was 90 mg / dL, the high flow rate range was 500-700 ml / min, the medium flow rate range was 350-500 ml / min, and the low flow rate range was 150-300 ml / min.

[0058] For the moderately sensitive group, the first blood glucose concentration threshold was 70 mg / dL, the second blood glucose concentration threshold was 85 mg / dL, the high flow rate range was 500-800 ml / min, the medium flow rate range was 300-500 ml / min, and the low flow rate range was 100-300 ml / min.

[0059] For the low-sensitivity group, the first blood glucose concentration threshold was 60 mg / dL, the second blood glucose concentration threshold was 85 mg / dL, the high flow rate range was 600-850 ml / min, the medium flow rate range was 400-600 ml / min, and the low flow rate range was 200-400 ml / min.

[0060] S3. Monitor the patient's blood glucose concentration in real time during dialysis.

[0061] A fingertip-calibrated continuous glucose monitoring sensor, CGM, is used to monitor the patient's real-time blood glucose concentration during dialysis, denoted as . The unit is mg / dL.

[0062] The CGM data is calibrated every 20 minutes using fingertip blood glucose. If the calibration error is greater than 15%, the CGM data is corrected based on the fingertip blood glucose concentration, and the dialysate flow rate is paused for 1 minute for adjustment.

[0063] S4. Match the real-time blood glucose concentration with the blood glucose threshold range to determine the corresponding dialysate flow rate range.

[0064] when When the blood glucose concentration is below the first blood glucose concentration threshold, the high flow rate zone is entered and the dialysate flow rate is increased.

[0065] when When the blood glucose concentration is between the first and second blood glucose concentration thresholds, maintain the medium flow rate range;

[0066] when When the blood glucose concentration exceeds the second blood glucose concentration threshold, it enters the low flow rate zone.

[0067] In addition, in a hypoglycemic state, the dialysate flow rate needs to be increased as quickly as possible. The specific formula for calculating the high flow rate in a hypoglycemic state is as follows.

[0068] ;

[0069] in, The target dialysate flow rate, in mL / min, needs to be constrained within the high flow rate range of the corresponding group. The values ​​represent the median of the high flow rate range for different sensitivity groups: 600 for the high sensitivity group, 650 for the medium sensitivity group, and 725 for the low sensitivity group. The units are ml / min.

[0070] The proportionality coefficient was determined based on large-sample statistical analysis of a multicenter clinical controlled trial. The trial included end-stage renal disease dialysis patients in different insulin sensitivity groups, covering individuals with varying weights, baseline blood glucose levels, and dialysis durations. The coefficient was obtained by monitoring patients in each group at different values. The study focuses on three core indicators: glycemic correction rate, ultrafiltration rate stability, and hyperglycemia incidence. With the goal of minimizing glycemic target achievement time, minimizing ultrafiltration rate deviation, and minimizing hyperglycemia risk, a weighted scoring method was used to calculate different... The optimal value is ultimately selected based on the comprehensive score of the selected values. This embodiment uses the high-sensitivity group. Five groups were selected: a moderately sensitive group and a lowly sensitive group. Take 6.5.

[0071] This is a weight correction factor, calculated as the ratio of a patient's actual weight to their ideal weight. The low-sensitivity group has additional limitations. To avoid excessively high flow rates in obese patients. The first blood glucose concentration threshold for the corresponding sensitive group.

[0072] S5, Based on real-time blood glucose concentration Make dynamic adjustments to obtain .

[0073] During dialysis, when the dialysate is in glucose mode, the dialysate is rinsed at predetermined intervals, such as 5 minutes. Perform dynamic updates. The update formula is as follows.

[0074] ;

[0075] in, As correction coefficients, 0.05 is used for the high-sensitivity group, 0.075 for the medium-sensitivity group, and 0.1 for the low-sensitivity group, based on... Correlation analysis with intraoperative real-time blood glucose fluctuations determined that, through a large number of dialysis patients... Linear regression analysis was performed on the data and the trend of intraoperative blood glucose changes to clarify the differences in blood glucose levels under different groups. Differences in sensitivity to changes in intraoperative metabolic status were assessed, and a dynamically updated clinical validation trial was conducted to evaluate the results. The test aimed to achieve the highest degree of matching with the patient's actual metabolic status and the most reasonable frequency of dialysate parameter adjustments. Different value pairs The impact of update accuracy ultimately determines the different sensitive groups. Values. In this embodiment, the highly sensitive group... Take 0.05, medium sensitivity group Take 0.075, low sensitivity group Take 0.1.

[0076] S6, based on real-time blood glucose concentration and Predicting blood glucose concentration allows for the adjustment of dialysate type and flow rate.

[0077] First, assess the amplitude of blood glucose fluctuations. The calculation formula is as follows.

[0078] - ;

[0079] in, The blood glucose concentration was 5 minutes prior, obtained from historical data from the CGM sensor. Additionally, when calculated... When mg / dL, forced collection mg / dL, to ensure that the trend weighting factor needs to be determined subsequently. Always positive. The formula for determining this is as follows.

[0080] ;

[0081] After obtaining Then calculate the predicted blood glucose concentration using the following formula. .

[0082] ;

[0083] in, The rate of change of blood glucose can be calculated from the change in blood glucose concentration over the past 5 minutes, and the unit is mg / (dL∙min). To estimate the duration, this example uses 12 minutes.

[0084] After obtaining the current moment time Then, the determination of dialysate regulation is carried out and intervention is made in advance, as detailed below.

[0085] like Above the high sensitivity threshold, At mg / dL, the dialysate enters the high flow rate range; When the concentration is mg / dL, reduce the dialysate rate or switch to glucose-free dialysate;

[0086] like Located between the high sensitivity threshold and the low sensitivity threshold, in At mg / dL, the dialysate enters the high flow rate range; When the concentration is mg / dL, decrease the rate of action;

[0087] like Below the low sensitivity threshold, At a concentration of mg / dL, the dialysate enters the high-flow-rate range, simultaneously increasing the glucose concentration in the dialysate to 250 mg / dL; When the concentration is mg / dL, the rate is reduced.

[0088] The above are all preferred embodiments of this application, and are not intended to limit the scope of protection of this application. Therefore, all equivalent changes made in accordance with the structure, shape and principle of this application should be covered within the scope of protection of this application.

Claims

1. A method for regulating hemodialysis fluid for blood glucose concentration balancing, characterized in that: Specifically, the following steps are included: S1. Obtain the patient's initial insulin sensitivity index before dialysis. ； S2, based on S3. Set the blood glucose threshold range and dialysate flow rate range; S4. Monitor the patient's blood glucose concentration in real time during dialysis; S5. Match the real-time blood glucose concentration with the blood glucose threshold range to determine the corresponding dialysate flow rate range; S6. Based on the real-time blood glucose concentration... Make dynamic adjustments to obtain S6, based on real-time blood glucose concentration and Predicting blood glucose concentration allows for the adjustment of dialysate type and flow rate.

2. The method for regulating hemodialysis fluid for blood glucose concentration balance according to claim 1, characterized in that: In step S1, a preset dose of glucose solution is injected into the patient before dialysis. The rate of change in the patient's blood glucose concentration is monitored within a predetermined time after injection, and a calculation is performed based on the rate of change in blood glucose concentration. 。 3. The method for regulating hemodialysis fluid for blood glucose concentration balance according to claim 1, characterized in that: S2 refers to Set high-sensitivity and low-sensitivity thresholds; the blood glucose threshold range is based on... Adjustments are made to the comparison between the high sensitivity threshold and the low sensitivity threshold.

4. A method for regulating hemodialysis fluid concentration for blood glucose balance according to claim 3, characterized in that: The blood glucose threshold range includes a first blood glucose concentration threshold and a second blood glucose concentration threshold, wherein the second blood glucose concentration threshold is greater than the first blood glucose concentration threshold.

5. A method for regulating hemodialysis fluid concentration for blood glucose balance according to claim 4, characterized in that: The When the blood glucose concentration exceeds the high sensitivity threshold, the first blood glucose concentration threshold is 80 mg / dL, and the second blood glucose concentration threshold is 90 mg / dL. When the blood glucose concentration is between the high sensitivity threshold and the low sensitivity threshold, the first blood glucose concentration threshold is 70 mg / dL and the second blood glucose concentration threshold is 85 mg / dL. When the blood glucose concentration is below the low sensitivity threshold, the first blood glucose concentration threshold is 60 mg / dL and the second blood glucose concentration threshold is 85 mg / dL.

6. A method for regulating hemodialysis fluid concentration for blood glucose balance according to claim 3, characterized in that: The dialysate flow rate range includes a high flow rate range, a medium flow rate range, and a low flow rate range.

7. A method for regulating hemodialysis fluid concentration for blood glucose balance according to claim 6, characterized in that: The When the flow rate is above the high sensitivity threshold, the high flow rate range is 500-700 ml / min, the medium flow rate range is 350-500 ml / min, and the low flow rate range is 150-300 ml / min. When the flow rate is between the high and low sensitivity thresholds, the high flow rate range is 500-800 ml / min, the medium flow rate range is 300-500 ml / min, and the low flow rate range is 100-300 ml / min. When the flow rate is below the low sensitivity threshold, the high flow rate range is 600-850 ml / min, the medium flow rate range is 400-600 ml / min, and the low flow rate range is 200-400 ml / min.

8. A method for regulating hemodialysis fluid concentration for blood glucose balance according to claim 1, characterized in that: In S5 Based on initial insulin sensitivity index Sensitivity correction coefficient Real-time blood glucose concentration Fasting blood glucose concentration before dialysis Calculated based on The relationship between the high-sensitivity threshold and the low-sensitivity threshold is obtained.

9. A method for regulating hemodialysis fluid concentration for blood glucose balance according to claim 8, characterized in that: The blood glucose concentration is predicted in S6. based on Blood glucose rate of change , Predicted duration and trend weighting factor Calculated based on and blood sugar fluctuation range Obtained through calculation.

10. A method for regulating hemodialysis fluid concentration for blood glucose balance according to claim 9, characterized in that: If in S6 Above the high sensitivity threshold, At mg / dL, the dialysate enters the high flow rate range; When the concentration is mg / dL, reduce the dialysate rate or switch to glucose-free dialysate; like Located between the high sensitivity threshold and the low sensitivity threshold, in At mg / dL, the dialysate enters the high flow rate range; When the concentration is mg / dL, decrease the rate of action; like Below the low sensitivity threshold, At a concentration of mg / dL, the dialysate enters the high-flow-rate range, simultaneously increasing the glucose concentration in the dialysate to 250 mg / dL; When the concentration is mg / dL, the rate is reduced.

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