Insulin optimization systems and testing methods with adjusted exit criterion accounting for system noise associated with biomarkers
Insulin optimization systems and testing methods with adjusted exit criterion accounting for system noise associated with biomarkers
 CN 102,946,804 A
 Filed: 06/14/2011
 Published: 02/27/2013
 Est. Priority Date: 06/18/2010
 Status: Active Application
First Claim
1. a system that is configured to instruct by test plan diabetics comprises:
 Be coupled to the processor of memorizer, wherein said memorizer comprises the collection rules;
AndSoftware with instruction makes described processor when described instruction is carried out by described processor;
Via user interface, indicate described diabetics to carry out one or more sampling set of collection of biological flag data according to described collection rules, wherein each sampling set is included in to collect in the period and is recorded in the one or more sampling examples in described memorizer, and each sampling example comprises one or more biological marker readings;
AndBy described processor or other processors, come to add up to calculation probabilitydistribution function, dangerous function, risk function and risk numerical value for the sampling set of biomarker data, wherein,Calculating is similar to the probabilitydistribution function of the probability distribution of described biomarker data,Dangerous function is the function that a kind of biological marker reading for the higher complication risk of indication in described sampling set produces higher risk numerical value,Risk function is the product of probabilitydistribution function and dangerous function, andIntegration by risk function carrys out calculation risk numerical value;
Indicate described diabetics to make the risk numerical minimization by the therapy of regulating the patient, if or be minimized to optimum risk level exit this method of testing at least one the risk numerical value gathered of sampling.
Chinese PRB Reexamination
Abstract
Embodiments of a testing method for optimizing a therapy to a diabetic patient comprise collecting at least one sampling set of biomarker data, computing a probability distribution function, a hazard function, a risk function, and a risk value for the sampling set of biomarker data wherein, wherein the probability distribution function is calculated to approximate the probability distribution of the biomarker data, the hazard function is a function which yields higher hazard values for biomarker readings in the sampling set indicative of higher risk of complications, the risk function is the product of the probability distribution function and the hazard function, and the risk value is calculated by the integral of the risk function, minimizing the risk value by adjusting the diabetic patient'"'"'s therapy, and exiting the testing method when the risk value for at least one sampling set is minimized to an optimal risk level.

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48 Claims

1. a system that is configured to instruct by test plan diabetics comprises:

Be coupled to the processor of memorizer, wherein said memorizer comprises the collection rules;
AndSoftware with instruction makes described processor when described instruction is carried out by described processor; Via user interface, indicate described diabetics to carry out one or more sampling set of collection of biological flag data according to described collection rules, wherein each sampling set is included in to collect in the period and is recorded in the one or more sampling examples in described memorizer, and each sampling example comprises one or more biological marker readings;
AndBy described processor or other processors, come to add up to calculation probabilitydistribution function, dangerous function, risk function and risk numerical value for the sampling set of biomarker data, wherein, Calculating is similar to the probabilitydistribution function of the probability distribution of described biomarker data, Dangerous function is the function that a kind of biological marker reading for the higher complication risk of indication in described sampling set produces higher risk numerical value, Risk function is the product of probabilitydistribution function and dangerous function, and Integration by risk function carrys out calculation risk numerical value; Indicate described diabetics to make the risk numerical minimization by the therapy of regulating the patient, if or be minimized to optimum risk level exit this method of testing at least one the risk numerical value gathered of sampling.


2. the system of claim 1 is wherein that group from comprising the following is selected for the therapy of the diabetics that makes described risk numerical minimization:
 regulate insulin dose, regulate the diabetics behavior in order to reduce the biological marker transmutability, regulate target organism sign level or its combination.

3.
3., wherein, for described risk numerical minimization is arrived to optimal level, there is not the dangerous numerical value of indication hyperglycemia or hypoglycemia event in the system of claim 1.

4. the system of claim 1, wherein said collecting device is continuous glucose monitoring instrument, for obtaining the timeresolved glucose information that offers described processor as biomarker data.

5. the system of claim 1, also comprise therapy equipment, and it is configured to make diabetics to take insulin.

6. the system of claim 1, wherein said therapy equipment is novopen.

7. the equipment of claim 1, also comprise scalpel, and its operation is used for puncturing the skin of described diabetics in order to obtain the blood glucose biological marker.

8. the equipment of claim 1, also comprise the instrument that is configured to measure one or more selected biological markers.

9. the test plan for the taking dose by for optimizing insulin instructs the method for diabetics, and the method is utilized data handling system and comprised:

Indicate one or more sampling set of diabetics collection of biological flag data via user interface section, wherein each sampling set is included in to collect in the period and is recorded in the one or more sampling examples in memorizer, and each sampling example comprises one or more biological marker readings; By described processor, come to add up to calculation probabilitydistribution function, dangerous function, risk function and risk numerical value for the sampling set of biomarker data, wherein, Calculating is similar to the probabilitydistribution function of the probability distribution of described biomarker data, Dangerous function is the function that a kind of biological marker reading for the higher complication risk of indication in described sampling set produces higher risk numerical value, Risk function is the product of probabilitydistribution function and dangerous function, and Integration by risk function carrys out calculation risk numerical value; Via described user interface or another user interface, indicate described patient to make described risk numerical minimization by the therapy of regulating the patient, if or be minimized to optimum risk level exit this method of testing at least one the risk numerical value gathered of sampling.


10. the method for claim 9 is wherein that group from comprising the following is selected for the therapy of the diabetics that makes described risk numerical minimization:
 regulate insulin dose, regulate the diabetics behavior in order to reduce the biological marker transmutability, regulate target organism sign level or its combination.

11.
11., wherein, for described risk numerical minimization is arrived to optimal level, there is not the dangerous numerical value of indication hyperglycemia or hypoglycemia event in the method for claim 9.

12. the method for claim 9, wherein also comprise and determine whether the Engage of standard that starts described test plan for described diabetics is satisfied.

13. an optimization is used for the method for testing of the therapy of diabetics, comprising:

At least one sampling set of collection of biological flag data, wherein each sampling is gathered the one or more sampling examples and each the sampling example that are included in record in the collection period and is comprised one or more biological marker readings; Sampling set for biomarker data adds up to calculation probabilitydistribution function, dangerous function, risk function and risk numerical value, wherein, Calculating is similar to the probabilitydistribution function of the probability distribution of described biomarker data, Dangerous function is the function that a kind of biological marker reading for the higher complication risk of indication in described sampling set produces higher risk numerical value, Risk function is the product of probabilitydistribution function and dangerous function, and Integration by risk function carrys out calculation risk numerical value; Make described risk numerical minimization by the therapy of regulating described diabetics;
AndWhen being minimized to optimum risk level, exits the risk numerical value at least one sampling set this method of testing.


14. the method for testing of claim 13 is wherein that group from comprising the following is selected for the therapy of the diabetics that makes described risk numerical minimization:
 regulate the insulin dose parameter, regulate the diabetics behavior in order to reduce the biological marker transmutability, regulate target organism sign level or its combination.

15. the method for testing of claim 14, wherein said insulin dose parameter is to select the group from comprising the following:
 basal dose parameter, insulin are to the carbohydrate parameter, parameters of insulin sensitivity, canteen increase parameter, the canteen offset parameter, the insulin active parameter with and the combination.

16. the method for testing of claim 14, wherein when described meansigma methods in or basically near described target organism sign level or scope, the perhaps target organism sign level through overregulating, and, when the standard deviation of described sampling set drops within the similar noise scope of last sampling set, risk level is minimized to optimal level.

17. the method for testing of claim 13, wherein said optimum risk level can be arranged by the doctor.

18. the method for testing of claim 13, wherein said probabilitydistribution function is to calculate according to the meansigma methods of described sampling set and standard deviation.

19. the method for testing of claim 13, wherein said probabilitydistribution function calculates with the Density Estimator device.

20. the method for testing of claim 13, wherein said dangerous function is a kind of generation higher risk numerical value of the biological marker reading for the indication hyperglycemia in described sampling set or hypoglycemia and the function that is created near the dangerous numerical value zero or zero within target organism sign level or target organism sign scope.

21.
21., wherein, for described risk numerical minimization is arrived to optimal level, there is not the dangerous numerical value of indication hyperglycemia or hypoglycemia event in the method for testing of claim 13.

22. the method for testing of claim 13, the collection period of wherein said sampling set is defined as:
 intraday a plurality of sampling examples, a plurality of sampling examples in one week, interior a plurality of sampling examples, or a plurality of sampling examples of the continuous several the skys in a week for weeks on end.

23. the method for testing of claim 13, wherein each sampling example comprises biological marker reading and other context data that are associated with described biological marker reading, and wherein said context data is to select the group from comprising the following:
 acquisition time, collect the date, the insulin quantity of eating up time, pressure, exercise, the energy level of nearest canteen, the time of medicine that comprises insulin and dosage, recommendation with and combination.

24. the method for testing of claim 14, wherein said insulin dose is variable during the described collection period.

25. the method for testing of claim 14, wherein said insulin dose during the described collection period in constant level.

26. the method for testing of claim 13, wherein said biological marker reading is the fasting glucose reading.

27. the method for testing of claim 13, wherein said biological marker reading comprises the information of the biological marker type about selecting from glucose, triglyceride, lowdensity lipid and high density lipid.

28. the method for testing of claim 13, wherein said insulin is basal insulin.

29. the method for testing of claim 14, also comprise according to the insulin regulation scheme and regulate described insulin dose, this is to compare to determine by the meansigma methods by the current sampling set completed and described target organism sign level, described insulin regulation scheme is defined as reaching the number of times of the required insulin dose adjusting of target insulin level and the quantity of each insulin dose through overregulating, and wherein said target insulin level is to reach the required quantity of described target organism sign level.

30. the method for testing of claim 17, wherein reach the horizontal D of described target organism sign by calculating _{target}essential insulin dose is determined described insulin regulation scheme, passes through equation calculate D _{target}, wherein,
M passes through equation definition based on from the first dosage d_{k1}to the second followup dosage d_{k}insulin adjusting from the first biological marker reading b_{k1}to the second followup biological marker reading b_{k}rate of change;  And
b_{target}it is target organism sign level.
 And

31. the method for testing of claim 30, wherein pass through equation calculate the insulin dose through overregulating after the adjusting of described insulin regulation scheme d_{k+1}, wherein λ
 be the scheme tuner parameters, its scope is from 0 to 1 and corresponding to the radical degree of insulin regulation scheme.

32. the method for testing of claim 31, wherein radical insulin regulation scheme is adjusted to maximum horizontal by insulin dose in the first adjusting, and comprises λ
 that numerical value is 1.

33. the method for testing of claim 31, wherein more not radical insulin regulation scheme incrementally is being adjusted to maximum horizontal by insulin dose in two doses is at least regulated, and comprises that numerical value is 0.5 or less λ
 .

34. the method for testing of claim 30, the wherein said insulin dose through overregulating can not surpass the maximum insulin dose arranged by the health care supplier.

35. the method for testing of claim 30, wherein by the health care supplier than add up to the D calculated for last sampling set _{target}estimate to realize the horizontal D of target organism sign for this sampling set _{target}the insulin dose calculated.

36. the method for testing of claim 27, wherein estimate the horizontal D of realize target biological marker for the maximum insulin dose arranged by the health care supplier _{target}the maximal dose calculated.

37. the method for testing of claim 14, wherein according to biological marker target regulation scheme, regulate described target organism sign level, described biological marker target regulation scheme is defined as target organism sign level to the adjusting or a series of adjusting that make for the level of the risk minimization of current amount of noise.

38. the method for testing of claim 16, the variation that wherein said similar noise scope is less than 10% from calculated last amount of noise.

39. the method for testing of claim 13, wherein pass through equation define dangerous function h (B), wherein bit is the biological marker reading in the sampling set.

40. the method for testing of claim 13, wherein pass through equation define dangerous function h (B), wherein bthe biological marker reading in the sampling set, h_{hypo}(B)the dangerous function be associated with the hypoglycemia event, h_{hyper}(B)it is the dangerous function be associated with the hyperglycemia event.

41. the method for testing of claim 39, wherein, h_{hypo}(B)be , and h_{hyper}(B)be .

42. the method for testing of claim 13, wherein said dangerous function is the index that the biological marker reading is associated with corresponding dangerous numerical value.

43. the method for testing of claim 13, also comprise one or more additional sample set of when described risk level, collecting described biomarker data during not in optimal level.

44. the method for testing of claim 13, wherein obtain risk numerical value by following equation j:
。

45. the method for testing of claim 13, also be included in described risk and be minimized to after optimal level and carry out new test plan.

46. the method for testing of claim 13, also be included in and carry out meeting Engage of standard before test plan.

47. the method for testing of claim 13, also be included in the whole collection period and meet adherence to standard.

48. the method for testing of claim 47, wherein said adherence to standard requires the empty stomach period before the sampling set of collection of biological flag data.
Specification(s)