This invention is directed to a system and method for optimizing the control of blood glucose for diabetic subjects. In particular, this invention is directed to a system incorporating a processor whose logic optimizes the control of the blood glucose of the diabetic subject based upon a subject blood glucose level reading at a particular time period and a meal type having been ingested or to be ingested. Still further, this invention pertains to an optimized control of the blood glucose level for developing a recommended insulin dosage dependent upon a time period defined as a pre-meal, post-meal, bedtime, mid-sleep, or miscellaneous blood glucose reading taken with a standard glucometer. Additionally, this invention pertains to a system which takes into account both the meal type such as breakfast, lunch, dinner, or snack. Further, this invention is directed to a system which utilizes the past history of the subject for a particular meal type and time period to optimize the blood glucose level for the diabetic subject. Still further, this invention pertains to optimization of blood glucose levels based upon estimated carbohydrates to be ingested by the subject at a particular meal type in association with whether or not the subject is on a meal plan.
Diabetes is a growing problem in the world. Conventional treatment for diabetes requires that the patient measures his/her blood glucose several times a day with a glucometer. The patient then estimates the number of units of insulin that should be injected to prevent either hypoglycemia (too low blood glucose) or hyperglycemia (too high blood glucose) based upon the blood glucose reading and the type of food that the patient has ingested or expects to ingest. This generally is a trial and error solution which may have deleterious effects.
Diabetes or diabetes mellitus is a generally chronic disorder of glucose or sugar metabolism. This is generally caused by the inadequate production of insulin or inadequate use of the insulin generated. Insulin is a hormone produced in specialized cells in the pancreas which permits the body to use and store glucose. Diabetes is a leading cause of death in the World.
Lack of insulin for a subject results in the inability to metabolize glucose and the capacity to store glycogen in the liver and active transport of glucose across cell membranes are impaired
Symptoms of diabetes or diabetes mellitus results in elevated sugar levels in the urine and blood, as well as increased urination, thirst, hunger, weakness, and weight loss. Prolonged excess blood glucose levels (hypoglycemia) leads to increased protein and fat catabolism which may cause premature vascular degeneration and atherosclerosis. Where diabetes is not controlled, such leads to diabetic acidosis where ketones are built up in the blood.
Diabetes affects the body handling of fats which may lead to fat accumulation in the arteries and potential damage to the kidneys, eyes, heart, and brain. Thus, there is a great need for accuracy in controlling the blood glucose level of a diabetic subject to optimize the blood glucose level and have the subject maintain a stable blood glucose level within safe limits.
The optimization of blood glucose levels for a diabetic subject is a function of numerous interdependent parameters associated with time periods, meal types, ingested food products, prior history of the diabetic subject at respective time periods and meal types being ingested or to be ingested, as well as the physical condition of the subject. In order to optimize the insulin dosage to be administered to a subject, the interdependent parameters each having an effect on the other, have to be taken into account to produce a recommended insulin dosage level.
Thus, the subject system has been developed in order to optimize the insulin dosage recommended for a subject at a particular time period and further associated with a meal type based upon the above-referenced interrelated parameters.
Prior systems for recommending insulin dosage suffer from the fact that the previous history of the subject are not generally taken into account with respect to a particular time period and meal type either ingested or to be ingested.
Conventional treatments for diabetes require that the patient measure his/her blood glucose a predetermined number of times during a day with a standard glucometer. The patient may then estimate the number of units of insulin that he/she should inject for prevention of either hypoglycemia or hyperglycemia.
It is difficult for the diabetic subject to accurately estimate the number of grams of carbohydrates that he/she will ingest and in general the interrelated aforementioned parameters are not taken into account for optimizing glycemic control.
Thus, there is a great need for a system which calculates an optimized blood glucose level and insulin dosage to be recommended to the subject based upon a current blood glucose reading in association with a meal type, time period, physical condition, and previous history of blood glucose levels.
One aspect of the disclosure provides [an independent claim].
The subject system provides a system and method for optimizing the glycemic control of a diabetic subject based upon his/her past glycemic history and provides an optimized guidance as to the number of units of insulin or insulin dosage to be injected at any time depending on an extended set of factors. Each of these factors can affect the patient's need for insulin.
The diabetic patient or caregiver inserts base data into a computer system for estimating the number of grams of carbohydrates that the patient is about to ingest or has ingested at a particular meal type. The meal type and time period is further input as manual data inserted into the computer system.
Based upon the input data as to the current blood glucose reading and the aforementioned input data, the subject system calculates an insulin dosage which is optimized for the patient's particular condition at the current time.
One of the features of the subject system is that such provides for the patient the optimum number of units of insulin to be injected dependent on the subject's past history of blood glucose results under similar circumstances. As an example, if the subject measures a blood glucose rating of 100 mg/dl, such is input into the system and indicates to the system that there is an estimated ingestion of 30 grams of carbohydrates to be ingested or has previously been ingested, and the system states that 15 units of insulin should be injected, and then the next reading of blood glucose is 70 mg/dl, such would result in an undesirably low reading. At a subsequent time that the subject takes the same or similar blood glucose reading and the number of grams of carbohydrates to be eaten is inserted, then the system knowing that 15 units of insulin is too high a dose, the system may suggest 13 units of insulin to prevent a low reading of blood glucose. Thus, an important feature of the subject system is that the patient's prior glycemic history is stored by the system and subsequently used in calculations for recommending insulin to be injected dependent upon prior results experienced by the specific subject.
Referring now to
The following definitions of the terminology used in the following paragraphs are as follows:
Mid-point target blood glucose range (Tm) shall refer to the mid-point of a target blood glucose range (or other blood glucose value within the range) inserted into remote processor 114 by a physician or caregiver for a subject. Although referring to “mid-point” of the blood glucose range, the mid-point target data may be inserted as a function of the mid-point of the mid-point target blood glucose range or some other input deemed appropriate by the subject's physician or caregiver.
Time periods shall refer to the time that a subject is taking a blood glucose reading with a standard glucometer and further refers to a pre-meal time period, a post-meal time period, a bedtime period, a mid-sleep time period, or some miscellaneous time period when the subject is taking the blood glucose reading.
Meal type shall refer to either breakfast, lunch, dinner, snack, or miscellaneous associated with when the subject is taking the subject's blood glucose reading.
Blood glucose reading shall be the blood glucose reading taken at a predetermined time period and associated with a meal type.
Bolus shall refer to recommended insulin dose administered for a meal type and a time period.
Basal Dose shall refer to a total basal dosage of insulin to be taken for one day.
Hypoglycemia threshold shall refer to a lower blood glucose value for a particular subject provided by a physician or other caregiver.
Prior blood glucose doses and/or levels shall refer to previous blood glucose doses and/or levels taken or calculated at previous time periods associated with a respective meal type.
Basal insulin type shall refer to the type or brand of long acting insulin used with basal dose calculations.
Bolus insulin type shall refer to the type or brand of short acting insulin used with meal bolus and correction doses of insulin.
Basal dose distribution shall refer to the frequency and distribution of basal doses for a particular day such as (1) once a day (SID); (2) twice a day (BID); or, (3) three times a day (TID).
Physical condition parameter shall refer to a physical condition of the subject at the time that the blood glucose reading is being taken such as whether or not the subject is exercising or plans to exercise.
Intermediate blood glucose correction dosage shall refer to a first calculation by processor 116 shown in
Carbohydrate to insulin ratio is a subject specific factor based upon a function of the total daily dose of insulin based upon the subject's weight at the time of initialization of the system 100 processes.
Meal plan shall refer to whether or not the subject is limited to ingesting a known number of carbohydrates for each meal type. When a subject is “on” a meal plan, the subject is generally prescribed a predetermined number of carbohydrates to be ingested at a selected meal type.
Miscellaneous time period shall refer to blood glucose calculations at a time period which is not associated with the time periods of breakfast, lunch, dinner, or snack. Such a miscellaneous time period may be associated with a subject fasting period when blood glucose calculations are being processed.
Mid-sleep time period shall refer to blood glucose readings taken at a time during a time period when the subject is normally asleep, generally at some point during a sleeping cycle of the subject.
Insulin sensitivity factor shall refer to a subject specific sensitivity to insulin, generally determined by a physician or care giver and inserted as a portion of the data stored in the remote processor.
System processor shall refer to an on-site processor which calculates a user's recommended insulin dosage value to be taken at a selected time period and a selected meal type.
Remote processor shall refer to a processor which is coupled to the system processor and stores a first set of a subject's blood glucose parameters and includes but is not limited to prior basal and bolus dosages, prior or previous blood glucose readings for selected meal types and time periods, subject specific hypoglycemia thresholds, prescribed mid-point of a subject's target range, a subject specific insulin sensitivity factor, basal insulin type, bolus insulin type, basal dose distributions, and the number of carbohydrates a subject is recommended to ingest for a selected meal type. The remote processor is generally locationally removed (but in communication) with the system processor, however in some cases the remote processor may be incorporated with the system processor.
Referring now to
Further, data is inserted by the subject in block 101 as to the physical condition of the subject at the time of the taking of the blood glucose value. The data inserted in block 101 will further be described throughout the flow process and in particular with regard to
The blood glucose reading taken in block 102 and the subject physical condition in block 101 is inserted into processor 116 on line 118. Within block 103, a determination of the physical condition of the subject is made independent of further calculations within processor 116 to be further detailed in relation to
If the condition is an exercise condition, found in decision block 302 of
If the blood glucose level value in decision block 320 is found to be less than the mid-point target blood glucose range, information is directed on line 326 to block 318 where the subject is instructed to eat a predetermined amount of carbohydrates for each predetermined minutes of exercise being planned or having been accomplished. This instruction is then provided to the patient on subject display 110 on line 324 and the information is additionally sent to remote processor 114 for storage of the instructions.
Thus, whether the condition is exercise determined in decision block 302, or whether or not the blood glucose level is less than the mid-point of the target blood glucose range determined in decision block 320, all logic then passes to blood glucose time period block 104 shown in
Once an intermediate processing or correction dosage calculation is completed in
Returning back to block 103, which has been detailed in the description of
System processor 116 and subject data display 110 may be incorporated within a standard Personal Computer System which has a standard monitor screen for permitting the subject to visually obtain the recommended insulin dosage value being calculated within the system processor 116 and/or the remote processor 114. The subject display monitor 110 generally provides visual data to the user, however, as is known, audio information may also be transmitted to the subject.
Referring now to
Information flow from within block 104 of
If it is determined in decision block 204 that the pre-meal type is breakfast, then the logic is transported on line 264 to block 212 for calculation of a blood glucose correction dosage or intermediate blood glucose correction dosage. Block 212 includes the processing of the logic blocks in
Where insulin has not been administered within a predetermined time period found in decision block 402, information is directed to decision block 412 on line 430 for determination of whether the instant or current blood glucose level reading from the glucometer in block 102 is less than the hypoglycemia threshold value stored in block 114. If the blood glucose reading is equal to or greater than the hypoglycemia threshold value, information is transported on line 432 to decision block 404 where a determination is made whether the blood glucose reading is greater than the mid-point of the target blood glucose range (TM).
If it is determined that the blood glucose reading is less than the mid-point of the target blood glucose range, information is directed on line 434 back to block 408 where there is “no correction dose recommended” and the information flows back to
Where it is determined that the blood glucose reading is greater than the mid-point of the target blood glucose range in block 404, the logic then passes on line 436 to calculation block 410 where the intermediate correction or correction insulin dosage is calculated. The intermediate blood glucose correction dosage calculated in block 410 is a function of the blood glucose reading, the mid-point of the blood glucose target range, and the subject sensitivity factor in accordance with the formula:
Where: CD=correction dose calculated (units of insulin)
BG=blood glucose reading (mg/dl)
Tm=mid-point of blood glucose target range (mg/dl)
S1=patient insulin sensitivity factor (units/mg/dl)
Once the blood glucose correction dosage is determined in calculation block 410, information is directed to decision block 480 on line 438. Since the correction dosage and associated logic of
If both of the conditions are met (e.g., meal type is pre-meal and time period is breakfast), information then is directed on line 440 to transfer block 422 which is representative of
If there is a previous mid-sleep blood glucose level availability, information is directed on line 430 to decision block 602 to determine whether the previous mid-sleep blood glucose level was less than the previous breakfast blood glucose level reading stored in remote processor 114. If the previous mid-sleep blood glucose level is less than or equal to the previous breakfast blood glucose level, the logic passes on line 614 to calculation block 604 for calculating an adjustment factor using the previous mid-sleep blood glucose level.
Calculation of the adjustment factor using the previous mid-sleep blood glucose level is shown in
If the previous mid-sleep blood glucose level is greater than the previous breakfast blood glucose level in decision block 602, information is transported on line 630 to processing block 606 where the adjustment factor is calculated using the previous breakfast blood glucose level in accordance with the adjustment factor found in
Calculation blocks 604 and 606 are calculated in
Once the proper adjustment factor is defined in blocks 704, 708, 712, 716, or 720 information flows on respective lines 722, 724, 726, 728, or 730 to transfer block 732 where information returns to either blocks 604 or 606 in
As stated, the adjustment factor after being calculated in
Thus, as shown in
Returning now to
Returning back to
Returning now to
Similarly, if the time period is pre-meal and meal type is lunch, calculations of the intermediate blood glucose correction dosage for lunch is calculated in
In all processing and calculation blocks 212, 214, 216, and 218, the calculations are provided in association with the previous logic flow description given for the logic blocks in
Information from
If the time period is pre-meal and the meal type is breakfast, calculation of the adjustment factor is made in block 510 in accordance with
CB=CBi×AF (2)
Where:
CB=current bolus (units of insulin)
CBi=previous bolus administered at the previous Meal type and time period (units of insulin)
AF=adjustment factor (dimensionless)
The current bolus is then passed on line 554 to subject data display 110 and eventually to remote processor 114 as provided in
TDD=TDDM×WS (3)
Where:
TDD=total prescribed daily basal dose of insulin (units of insulin)
WS=weight of subject (Kg.)
TDDM=subject's Total Daily Dose Multiplier (a weighting factor having dimensions of (units per Kg/day). Typically 0.25 for pediatric subjects, 0.3 for subjects with renal insufficiency, 0.5 for adult subjects, or another subject specific number)
Once the total prescribed daily basal dose is calculated in equation (3), within block 586, the meal of bolus (CB) is calculated by first calculating the carbohydrate to insulin ratio (dimensionless) in accordance with the formula:
CIR=450×TDD (4)
Where:
CIR=current carbohydrate to insulin ratio (dimensionless)
TDD=total prescribed basal dose of insulin (units of insulin)
Using the previous selected pre-meal CIR to calculate the instant CIR for a particular meal type is made in accordance with the formula:
Where: CIRB,L,D,S=instant carbohydrate to insulin ratio for a selected meal type of breakfast, lunch, dinner, or snack
CIRB,L,D,S=previous carbohydrate to insulin ratio for previous selected meal type of breakfast, lunch, dinner or snack
AF=adjustment factor
Finally, the current bolus to be recommended is derived from the Equation:
Where: CEST=estimated number of carbohydrates to be ingested at the pre-meal time period for the current meal type (mg.)
CIRB,L,D,S=calculated carbohydrate to insulin ratio calculated in Equation 5.
Subsequent to the calculation of the current bolus in block 518 or block 586, information passes on respective lines 554 and 555 to subject data display 110 and then to remote processor 114.
If it is determined in decision block 502 that the meal is not breakfast, information is directed on line 536 to decision block 504 where a decision is made as to whether the meal is lunch. If the pre-meal is lunch, then information is passed on line 538 to calculation block 512 for calculation of the adjustment factor in
If it is determined that the meal type is not lunch in decision block 504, information is transported on line 542 to decision block 506 where it is determined whether the meal type is dinner. If the meal type is dinner, information is inserted to calculation block 514 on line 544 for calculation of the adjustment factor provided by the logic in
If it is determined in decision block 506 that the meal is not dinner, information then flows on line 548 to decision block 508 where it is determined whether the meal type is a snack. If it determined in decision block 508 that the meal is a snack, information passes on line 550 to calculation block 516 where the adjustment factor is calculated in accordance with
In this manner, when the blood glucometer reading is taken as represented by block 102, and the physical condition is input by the subject as represented by block 101, when the time period of the blood glucose reading is taken is pre-meal as is determined in decision block 202, a breakfast, lunch, dinner, and snack bolus is calculated by system 100.
If the meal type is not a snack, then the time period is miscellaneous and passes on line 598 to transfer block 599 where logic is transferred to line 288 in
Returning to
Calculation block 240 directs the information to
Similarly, as has previously been described for the pre-meal type calculations in decision blocks 206, 208, and 210, a decision is made as to the fact whether the post-meal blood glucose reading is taken subsequent to lunch in decision block 234, dinner in decision block 236, or a snack in decision block 238. If it is determined that the post-meal blood glucose reading is subsequent to lunch in decision block 234, the information then is inserted into calculation block 242 for calculation of the post-meal lunch correction as associated with the logic flow previously described for
If the decision in decision block 234 is that the post-meal was not lunch, the information then is directed to decision block 236 for determination of whether the post-meal blood glucose reading was dinner and if it is dinner, the logic flows to block 244 and correction dosage as well as the subject meal bolus is made in association with
If the blood glucose post-meal reading is a snack determined in decision block 238, similarly as previously described, the information is directed to calculation block 246 for calculation in the same manner as previously described for the post-meal breakfast, lunch and dinner decisions. Information from blocks 240, 242, 244, and 246 are then provided on line 284 to both subject display 110 and remote processor 114 for storage of the data and display of the recommended correction reading.
If it is determined in decision block 230 that the blood glucose time period is neither a pre-meal nor a post-meal, the information is directed on line 290 to decision block 248 where it is determined whether the blood glucose taken is at the time period of bedtime (prior to sleep).
With the blood glucose reading provided in block 101, the information is directed to calculation block 254 for insert into the logic flow of
Assuming that the blood glucose type is not found to be bedtime in decision block 248, information is then inserted on line 292 to decision block 250 where the blood glucose reading time period is taken as “mid-sleep”. If the blood glucose reading is taken as a mid-sleep type reading, information then is inserted into calculation block 256 where the calculation correction is transmitted to the logic previously detailed for
In the event that the blood glucose reading provided in block 101 is not a mid-sleep reading as determined in decision block 250, the information then passes on line 204 to calculation block 252 where the meal type is defined as miscellaneous since it is neither for a breakfast, lunch, dinner, or snack reading. The information in 252 is then directed to calculation block 258 where the bolus is calculated in accordance with
In the event that the blood glucose reading meets the time criteria period of a pre-meal, but is not at breakfast, lunch, dinner, or snack as determined in decision blocks 204, 206, 208, and 210, then the meal type must be “miscellaneous” and the information passes on line 288 into block 252 and 258 for calculation of the correction dosage. As seen in
In overall concept, there is provided in
System 100 provides the patient with calculated insulin dosage instructions based on nutritional and physical information, as well as personal history of insulin administration and resulting blood glucose levels as previously described. The calculated insulin dosage instructions are output to the subject on subject data display 110 which can be the monitor of a PC or through some other type of audio or sensory indication to the subject. The resulting data is then inserted into remote processor 114 for storage of the data where prior basal dosages, prior blood glucose doses, hypoglycemia thresholds, subject insulin sensitivity factor, whether a meal plan is in effect, and mid-point of target ranges are maintained in storage.
Once the user has manually input the current glucometer reading of his/her blood glucose level from block 102 along with the time period and meal type as represented in block 105, the subject further includes input as to a physical condition from block 101. All of this data is then inserted into processor 116 where the physical condition is initially calculated independent of the further processing to be accomplished by processor 116. The physical condition may require administration of a predetermined amount of carbohydrates as calculated in
System 100 then processes all data drawing on the preset conditions and subject history for determining optimum dosage levels of the subject's current condition where all calculated data is then displayed as represented by block 110 and the calculated data is then stored in remote processor 114.
If the time period is pre-meal as determined in decision block 202, the patient elects or indicates whether the pre-meal reading is breakfast as shown in decision block 204. As previously described, if the pre-meal is not breakfast, the election is made for lunch in decision block 206, dinner in block 208, or a snack in decision block 210. An algorithm within processor 116 calculates the dosage correction for the planned meal using the calculation algorithm as previously described in
In the time period of pre-meal and breakfast, the basal dose is adjusted as indicated in block 220 in association with the logic flow shown in
For all pre-meals such as breakfast, lunch, dinner, snack, or miscellaneous, the pre-meal bolus or recommended insulin dosage is calculated in associated blocks 228, 222, 224, and 226. If the meal type is neither breakfast, lunch, dinner, or a snack, then it is defined as a miscellaneous time period and the calculations for the bolus are input into block 252 and the calculated correction is made in block 258 as previously detailed. All recommended optimum doses to be taken in any of the time periods is then displayed to the subject on display 110 and the data inserted into remote processor 114 for further use for subsequent blood glucose readings at specific meal types and time periods.
Mealtime nutritional information may be input by the subject and a post-meal bolus correction is calculated for correcting unacceptable blood glucose levels within the logic of processor 136 as indicated by block 108 in
In the event that the time period of the blood glucose reading is post-meal and determined in decision block 230, once again the meal type is determined from the decision blocks 232, 234, 236, or 238 for respective calculation of the post-meal type correction in respective blocks 240, 242, 244, and 246. Each of the decision blocks 230, 232, 234, 236, and 238 determine a series of decision blocks where a positive indication for one decision block defines a negative indication for other decision blocks in this series.
As shown in
In the event that one of the meal types previously discussed are found for either the pre-meal, post-meal, mid-sleep or bedtime calculations, the meal type is defaulted to input block 252 where it is determined that the meal type is miscellaneous and then passes to calculation block 258 for calculation in accordance with the calculations processed in
If the insulin has not been given within the predetermined period of time (which is generally two hours), it is determined in decision block 412 whether the subject's blood glucose level is below a pre-set hypoglycemia risk level (H1) (hypoglycemia threshold). If it is not below the H1, information then is directed to decision block 404 where it is determined whether the blood glucose reading is greater than the mid-point of the target range and if it is not, information is then sent back to block 408 where no correction dose is recommended and the system returns to
If the blood glucose reading is greater than the mid-point of the target range as determined in decision block 404, the information then is directed to block 410 where a correction dosage is calculated as previously discussed in relation to the correction dosage equation. The correction dosage is then inserted into decision block 480 where it is determined whether the time period is pre-meal and whether the meal type is breakfast. If the data corresponds to both of these two criteria, the information is then inserted into
In overall concept, if the decision in decision block 412 determines that the blood glucose level is below H1, the system requests input in decision block 414 regarding the consciousness of the subject. If consciousness is not impaired, the data then flows to block 420 for administration of a predetermined amount of oral glucose (generally 15 grams). If the subject does have impaired consciousness, the physician or caregiver is then instructed to either administer glucogen in block 420 or if there is IV access, for intravenous insertion of an insulin based upon a 50% saline solution and insulin in accordance with the previously defined equations.
Sub-system 500 shown in
Sub-system 600 shown in
Although this invention has been described in connection with specific forms and embodiments thereof, it will be appreciated that various modifications other than those discussed above may be resorted to without departing from the spirit or scope of the invention as defined in the appended claims. For example, functionally equivalent elements may be substituted for those specifically shown and described, certain features may be used independently of other features, and in certain cases, particular locations of elements, steps, or processes may be reversed or interposed, all without departing from the spirit or scope of the invention as defined in the appended claims.
This U.S. patent application is a continuation of, and claims priority under 35 U.S.C. § 120 from, U.S. patent application Ser. No. 15/862,819, filed on Jan. 5, 2018, which is a continuation of U.S. patent application Ser. No. 13/610,287, filed on Sep. 11, 2012. The disclosures of these prior applications are considered part of the disclosure of this application and are hereby incorporated by reference in their entireties.
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Entry |
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Kaufman et al. (Diabetes Metab. Res. Rev., 1999, vol. 15, p. 338-352). (Year: 1999). |
Number | Date | Country | |
---|---|---|---|
20220074883 A1 | Mar 2022 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 15862819 | Jan 2018 | US |
Child | 17474001 | US | |
Parent | 13610287 | Sep 2012 | US |
Child | 15862819 | US |