Patent Description:
Today, nearly <NUM>% of patients admitted to acute care hospitals in the United States experience either hyperglycemia or hypoglycemia, both serious medical conditions. Many of these patients have diabetes while others have fluctuating blood sugars due to trauma, drug reactions, stress and other factors. Nurses and doctors managing these patients manually calculate insulin doses using complex paper protocols.

Manual calculation may not be accurate due to human error, which can lead to patient safety issues. Different institutions use multiple and sometimes conflicting protocols to manually calculate an insulin dosage. Moreover, the protocols may include extra paperwork that nurses and physicians have to manage, which in turn leads to workflow inefficiencies, additional operating costs, and employee satisfaction issues. SCIP (Surgical Care Improvement Project) scores, length of stay, readmission and even mortality rates adversely affect sub-optimal glycemic management.

The prevalent method of regulating continuous intravenous insulin infusion is by using a set of written instructions, known as a paper protocol. Paper protocols often involve a tree of conditional statements and some use of tables of numbers, for which a given blood glucose value dictates the use of a different column of insulin rates. The complexity of these paper protocols multiplies the probability of error by the nurses using them. These errors can lead to hypoglycemic events. <CIT> discloses a method of analysing and prescribing changes to the daily insulin dosing schedule of diabetic patients. The method involves determining a prescription insulin, which is equal to the sum of basal insulin, delivered over a given time interval, and meal insulin, delivered in relation to a meal taken during the given time interval. A total daily insulin dosage is calculated from the sum of the prescription insulin and a corrective insulin.

One aspect of the disclosure provides a method of managing insulin. The method includes receiving blood glucose measurements on a computing device from a glucometer. The blood glucose measurements are separated by a time interval. For each time interval, the method includes determining, using the computing device, an intravenous insulin infusion rate based on the blood glucose measurements of the time interval. The method further includes determining, using the computing device, a blood glucose percentage drop based on the blood glucose measurements (e.g., between a current blood glucose measurement and a previous blood glucose measurement). The method optionally further includes determining, using the computing device, a blood glucose drop rate based on the blood glucose measurements and the time interval. The method also optionally includes decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose percentage drop is greater than a threshold percentage drop and decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose drop rate is greater than a threshold drop rate. The method optionally further includes sending the intravenous insulin infusion rate from the computing device to an insulation administration device.

Implementations of the disclosure may include one or more of the following optional features. In some implementations, the method includes setting the time interval between the blood glucose measurements by the glucometer to a default time interval or a minimum of a preconfigured hypoglycemia time interval when a current blood glucose measurement is less than a threshold hypoglycemia blood glucose value. The method includes setting the time interval to a minimum of a preconfigured short time interval when the current blood glucose measurement is greater than the threshold hypoglycemia blood glucose value and less than a lower limit of a blood glucose target range and the blood glucose percentage drop is greater than a low blood glucose percentage drop limit or the current blood glucose measurement is greater than or equal to the lower limit of the blood glucose target range and the blood glucose percentage drop is greater than a regular blood glucose percentage drop limit. In some examples, the method includes setting the time interval to a minimum of a preconfigured blood glucose drop rate time interval when the blood glucose drop rate is greater than a blood glucose drop rate limit, a preconfigured long time interval when the blood glucose measurements have been within the blood glucose target range for a duration of time greater than a stable time period or a preconfigured meal bolus time interval when a meal bolus program is in operation. The preconfigured hypoglycemia time interval is less than the short time interval, the short time interval is less than the blood glucose drop rate time interval, the blood glucose drop rate time interval is less than the long time interval, and the meal bolus time interval is less than the long time interval.

In some examples, the method includes leaving the multiplier unchanged between time intervals when the current blood glucose measurement is greater than an upper limit of a blood glucose target range and a ratio of the current blood glucose measurement divided by a previous blood glucose measurement is less than or equal to a threshold ratio. The method further includes multiplying the multiplier by a change factor when the current blood glucose measurement divided by the previous blood glucose measurement is greater than the threshold ratio. Additionally or alternatively, the method may include the constant being equal to <NUM>/dl and the threshold ratio being equal to <NUM>. The method may further include dividing the multiplier by the change factor when the current blood glucose measurement is less than a lower limit of the blood glucose target range.

The method may further include, in response to receiving an indication of patient solid food consumption, increasing the intravenous insulin infusion rate and maintaining the multiplier unchanged for at least two time intervals. In some examples, the method includes receiving, at the computing device, a number of estimated grams of carbohydrates for a meal and determining, using the computing device, an estimated meal bolus in units of insulin based on the number of estimated grams of carbohydrates and a carbohydrate-insulin-ratio. The method may further include determining, using the computing device, an estimated meal bolus insulin rate, based on the estimated meal bolus, an available delivery time, and a configurable constant, and determining, using the computing device, a total insulin rate as a sum of the intravenous insulin rate and the estimated meal bolus insulin rate. The method may further include sending the total insulin rate from the computing device to the insulin administration device. Additionally or alternatively, the method may include dividing a total meal time into meal time sub-intervals, a first meal time sub-interval starting with a pre-meal blood glucose measurement before receiving the indication of patient solid food consumption, and determining, using the computing device, the total insulin rate for each meal time sub-interval in succession.

In some examples, the method includes receiving, at the computing device, a number of actual grams of carbohydrates for the meal during a subsequent time interval after the first time interval and determining, using the computing device, an actual meal bolus based on the number of actual grams of carbohydrates. The method also includes, determining an estimated delivered meal bolus by multiplying the estimated meal bolus rate times an elapsed delivery time. The method may further include determining a remaining meal bolus in units of insulin, using the computing device, by subtracting a product of the estimated delivered meal bolus insulin rate and an actual delivery time from the actual meal bolus. In addition, the method may include determining, using the computing device, a revised meal bolus insulin rate as the remaining meal bolus divided by a time remaining in the total meal time and determining, using the computing device, a revised total insulin rate as a sum of the intravenous insulin rate and the revised meal bolus insulin rate. Further, the method may include sending the revised total insulin rate from the computing device to the insulin administration device. The method may also include decreasing the time interval to less than the default time interval for the one or more meal time sub-intervals.

In some implementations, the method includes electronically displaying on a display in communication with the computing device a warning and blocking transition to a subcutaneous administration of insulin when the current blood glucose measurement is outside a stability target range and electronically displaying on the display a warning when the current blood glucose measurement is within the stability target range for less than a threshold stability period of time. The method may further include determining, using the computing device, a total daily dose of insulin based on the multiplier when the current blood glucose measurement is within a stability target range for a threshold period of time. The method further includes determining, using the computing device, recommended insulin dose comprising a daily basal insulin and a daily meal insulin for subcutaneous therapy as an apportioning of the total daily dose of insulin, wherein the daily basal insulin is half of the total daily dose of insulin and the daily meal insulin is half of the total daily dose of insulin. Further, the method includes sending the recommended insulin does from the computing device to a subcutaneous injection device or electronically displaying the recommended insulin doses on a display in communication with the computing device.

In some examples, when the blood glucose drops more than a threshold percent of its previous value, the method includes decreasing the time interval. This threshold percent is configured with two values: <NUM>) a lower (more sensitive) value when the blood glucose is below the low limit of the target range but above the hypo-threshold; and <NUM>) a higher (less stringent) value when the blood glucose is above the low limit of the target range. The method may include setting the time interval to a hypoglycemia time interval of between about <NUM> minutes and about <NUM> minutes when the current blood glucose measurement is below the hypo-threshold blood glucose level.

Implementations of the disclosure may include one or more of the following features. In some implementations, the method determining the insulin dose rate using the current blood glucose measurement, a constant (e.g., <NUM>/dl), and a unit-less multiplier.

The method includes adjusting the multiplier as follows: a) multiplying the multiplier by a change factor when the current blood glucose measurement is greater than an upper limit of the blood glucose target range, and the ratio of the current blood glucose to the previous blood glucose is greater than a threshold-ratio; b) dividing the multiplier by a change factor when the current blood glucose measurement is less than a lower limit of the blood glucose target range; c) re-use the previous multiplier for two or more intervals starting at the manual initiation of a meal bolus infusion process; and d) leaving the multiplier unchanged between time intervals when none of conditions a, b, or c are applicable.

The method includes leaving the multiplier unchanged between time intervals when the current blood glucose measurement is greater than an upper limit of the blood glucose target range and the blood glucose drop rate is greater than or equal to a threshold rate of descent, and multiplying the multiplier by a change factor when the current blood glucose measurement is greater than an upper limit of the blood glucose target range and the blood glucose drop rate is less than the threshold rate of descent. Additionally or alternatively, the method includes dividing the multiplier by a change factor when the current blood glucose measurement is less than a lower limit of a blood glucose target range and leaving the multiplier unchanged between time intervals when the current blood glucose measurement is within the blood glucose target range. In some examples, the method includes leaving the multiplier unchanged for at least two subsequent time intervals when the current blood glucose measurement is a pre-meal measurement.

In some examples, a meal bolus infusion process allows for the calculation of mealtime insulin for patients consuming oral carbohydrates. These examples may include leaving the multiplier unchanged for at least two subsequent time intervals when the current blood glucose measurement is a pre-meal measurement. In some examples, the method includes receiving, on the computing device, a number of carbohydrates for a meal and determining, using the computing device, a meal bolus rate based on the number of carbohydrates and an intravenous insulin rate based on the blood glucose level. In addition, the method includes determining a Total Insulin Rate including the sum of the meal bolus rate and the intravenous insulin rate based on a blood glucose value. The method may further include setting the time interval to about <NUM> minutes immediately following the pre-meal blood glucose and for the next glucose measurement time interval. If the blood glucose measurement is a second consecutive measurement after an initial pre-meal blood glucose measurement, the method includes setting the time interval to about <NUM> minutes.

In some implementations, the method includes decreasing the time interval when the current blood glucose measurement is greater than or equal to the lower limit of the blood glucose target range and the blood glucose drop rate exceeds a threshold drop rate. The method may also include setting the time interval to a default value of about one hour when the current blood glucose measurement is greater than or equal to the lower limit of the blood glucose target range and the blood glucose drop rate is less than or equal to a threshold drop rate. The method may include setting the time interval to a hypoglycemia time interval of between about <NUM> minutes and about <NUM> minutes, when the current blood glucose measurement is below the lower limit of the blood glucose target range and greater than a hypo-threshold blood glucose level.

In some implementations, the method includes decreasing the time interval when the current blood glucose measurement is below the lower limit of the blood glucose target range and below the hypo-threshold blood glucose level, and the blood glucose drop rate is less than or equal to a threshold drop rate. The method may also include setting the time interval to a default value of about one hour when the current blood glucose measurement is below the lower limit of the blood glucose target range and below the hypo-threshold blood glucose level, and the blood glucose drop rate is greater than the threshold drop rate.

In some examples, the method includes receiving, on the computing device, a number of carbohydrates per meal and determining, using the computing device, an intravenous insulin rate. In addition, the method includes determining, using the computing device, a meal bolus rate based on the number of carbohydrates and the insulin dose rate based on the intravenous insulin rate and the estimated meal bolus rate. The method may further include setting the time interval to about <NUM> minutes. If the blood glucose measurement is a second consecutive measurement after an initial pre-meal blood glucose measurement, the method includes setting the time interval to about <NUM> minutes.

In some implementations, the method includes a function to transition the insulin delivery method from an intravenous to subcutaneous basal-bolus regimen. The transition method provides doses and parameters for starting the patient on basal-bolus subcutaneous treatment. The transition method includes electronically displaying on a display a warning and blocking transition to a subcutaneous administration of insulin when the current blood glucose measurement is outside a stability target range. In addition, the method includes electronically displaying on the display a warning when the current blood glucose measurement is within the stability target range for less than a threshold stability period of time. In some examples, the method includes determining a total daily dose of insulin based on the multiplier when the current blood glucose measurement is within a stability target range for a threshold stability period of time.

Another aspect of the disclosure includes a system for managing insulin. The system includes a glucometer measuring blood glucose measurements separated by a time interval, an insulation administration device, and a dosing controller in communication with the glucometer and the insulation administration device. The dosing controller includes a computing device and non-transitory memory in communication with the computing device. The non-transitory memory stores instructions that when executed by the computing device cause the computing device to perform operations. The operations include receiving blood glucose measurements on a computing device from a glucometer, the blood glucose measurements separated by a time interval. For each time interval, the system includes determining, using the computing device, an intravenous insulin infusion rate based on the blood glucose measurements of the time interval and determining, using the computing device, a blood glucose percentage drop based on the blood glucose measurements (e.g., between a current blood glucose measurement and a previous blood glucose measurement). The system further includes determining, using the computing device, a blood glucose drop rate based on the blood glucose measurements and the time interval and decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose percentage drop is greater than a threshold percentage drop. The system further includes decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose drop rate is greater than a threshold drop rate and sending the intravenous insulin infusion rate from the computing device to the insulation administration device.

In some implementations, the system operations further include setting the time interval between the blood glucose measurements by the glucometer to a default time interval or a minimum of a preconfigured hypoglycemia time interval when a current blood glucose measurement is less than a threshold hypoglycemia blood glucose value or a preconfigured short time interval. The minimum of a preconfigured short time interval is set when the current blood glucose measurement is greater than the threshold hypoglycemia blood glucose value and less than a lower limit of a blood glucose target range and the blood glucose percentage drop is greater than a low blood glucose percentage drop limit or the current blood glucose measurement is greater than or equal to the lower limit of the blood glucose target range and the blood glucose percentage drop is greater than a regular blood glucose percentage drop limit. Further, the operations include setting the time interval between the blood glucose measurements by the glucometer to a minimum of a preconfigured blood glucose drop rate time interval when the blood glucose drop rate is greater than a blood glucose drop rate limit or a preconfigured long time interval when the blood glucose measurements have been within the blood glucose target range for a duration of time greater than a stable time period, or a preconfigured meal bolus time interval when a meal bolus program is in operation. The preconfigured hypoglycemia time interval is less than the short time interval, the short time interval is less than the blood glucose drop rate time interval, the blood glucose drop rate time interval is less than the long time interval, and the meal bolus time interval is less than the long time interval.

In some examples, the operations further include leaving the multiplier unchanged between time intervals when the current blood glucose measurement is greater than an upper limit of a blood glucose target range and a ratio of the current blood glucose measurement divided by a previous blood glucose measurement is less than or equal to a threshold ratio. The system further includes multiplying the multiplier by a change factor when the current blood glucose measurement is greater than the upper limit of the blood glucose target range and the ratio of the current blood glucose measurement divided by the previous blood glucose measurement is greater than the threshold ratio. In some examples, the constant equals <NUM>/dl and the threshold ratio is <NUM>. Additionally or alternatively, the operations may further include dividing the multiplier by the change factor when the current blood glucose measurement is less than a lower limit of the blood glucose target range. In some implementations, the operations further include, in response to receiving an indication of patient solid food consumption, increasing the intravenous insulin infusion rate and maintaining the multiplier unchanged for at least two time intervals.

The system may further include receiving, at the computing device, a number of estimated grams of carbohydrates for a meal, determining, using the computing device, an estimated meal bolus in units of insulin based on the number of estimated grams of carbohydrates and a carbohydrate-insulin-ratio and determining, using the computing device, an estimated meal bolus insulin rate, based on the estimated meal bolus, an available delivery time, and a configurable constant. The system may also include determining, using the computing device, a total insulin rate as a sum of the intravenous insulin rate and the estimated meal bolus insulin rate and sending the total insulin rate from the computing device to the insulin administration device. The system operations may further include dividing a total meal time into meal time sub-intervals, a first meal time sub-interval starting with a pre-meal bolus glucose measurement before receiving the indication of patient solid food consumption and determining, using the computing device, the total insulin rate for each meal time sub-interval in succession.

In some examples, the operations further include receiving, at the computing device, a number of actual grams of carbohydrates for the meal during a subsequent time interval after the first time interval, determining, using the computing device, an actual meal bolus based on the number of actual grams of carbohydrates and determining a meal bolus in units of insulin, using the computing device, by subtracting a product of the estimated meal bolus insulin rate and an actual delivery time from the actual meal bolus. The system may further include determining, using the computing device, a revised meal bolus insulin rate as the remaining meal bolus divided by a time remaining in the total meal time, determining, using the computing device, a revised total insulin rate as a sum of the intravenous insulin rate and the revised meal bolus insulin rate and sending the revised total insulin rate from the computing device to the insulin administration device. The operations may further comprise decreasing the time interval to less than the default time interval for the one or more meal time sub-intervals.

In some implementations, the operations include electronically displaying on a display in communication with the computing device a warning and blocking transition to a subcutaneous administration of insulin when the current blood glucose measurement is outside a stability target range and electronically displaying on the display a warning when the current blood glucose measurement is within the stability target range for less than a threshold stability period of time. In some examples, the operations include determining, using the computing device, a total daily dose of insulin based on the multiplier when the current blood glucose measurement is within a stability target range for a threshold stability period of time. The system also includes determining, using the computing device, recommended insulin dose including a daily basal insulin and a daily meal insulin for subcutaneous therapy as an apportioning of the total daily dose of insulin, wherein the daily basal insulin is half of the total daily dose of insulin and the daily meal insulin is half of the total daily dose of insulin. The system may further include sending the recommended insulin dose from the computing device to a subcutaneous injection device or electronically displaying the recommended insulin doses on a display in communication with the computing device.

The dosing controller may determine the insulin dose rate based on the current blood glucose measurement, a constant (e.g., <NUM>/dl), and a multiplier. The dosing controller leaves the multiplier unchanged between time intervals when the current blood glucose measurement is greater than an upper limit of the blood glucose target range and the blood glucose drop rate is greater than or equal to a threshold rate of descent. In addition, the dosing controller multiplies the multiplier by a change factor when the current blood glucose measurement is greater than an upper limit of the blood glucose target range and the blood glucose drop rate is less the threshold rate of descent. The dosing controller may leave the multiplier unchanged between time intervals when the current blood glucose measurement is less than a lower limit of the blood glucose target range, and it may divide the multiplier by a change factor when the current blood glucose measurement is within the blood glucose target range. In some examples, the dosing controller leaves the multiplier unchanged for at least two subsequent time intervals when the current blood glucose measurement is a pre-meal measurement.

In some implementations, the dosing controller decreases the time interval when the current blood glucose measurement is greater than or equal to the lower limit of the blood glucose target range and the blood glucose drop rate exceeds a threshold drop rate. In addition, the dosing controller sets the time interval to a default value of about one hour when the current blood glucose measurement is greater than or equal to the lower limit of the blood glucose target range and the blood glucose drop rate is less than or equal to a threshold drop rate. The dosing controller may set the time interval to a hypoglycemia time interval of between about <NUM> minutes and about <NUM> minutes, when the current blood glucose measurement is below the lower limit of the blood glucose target range and greater than a hypo-threshold blood glucose level.

In some examples, the dosing controller decreases the time interval when the current blood glucose measurement is below the lower limit of the blood glucose target range and below the hypo-threshold blood glucose level, and the blood glucose drop rate is less than or equal to a threshold drop rate. Moreover, the dosing controller sets the time interval to a default value of about one hour when the current blood glucose measurement is below the lower limit of the blood glucose target range and below the hypo-threshold blood glucose level, and the blood glucose drop rate is greater than the threshold drop rate.

In some examples, the dosing controller receives, on the computing device, a number of carbohydrates per meal, then determines, using the computing device, an intravenous insulin rate and a meal bolus rate based on the number of carbohydrates. Furthermore, the dosing controller determines, using the computing device, the insulin dose rate based on the intravenous insulin rate and the estimated meal bolus rate. The dosing controller may set the time interval to about <NUM> minutes. Additionally or alternatively, the dosing controller may set the time interval to about <NUM> minutes if the blood glucose measurement is a second consecutive measurement after an initial pre-meal blood glucose measurement.

In some examples, the dosing controller electronically displays on a display in communication with the dosing controller a warning and blocks transition to a subcutaneous administration of insulin when the current blood glucose measurement is outside a stability target range. The dosing controller electronically displays on the display a warning when the current blood glucose measurement is within the stability target range for less than a threshold stability period of time. The dosing controller may determine a total daily dose of insulin based on the multiplier when the current blood glucose measurement is within a stability target range for a threshold stability period of time.

Diabetic hospital patients who eat meals often have poor appetites; consequently, co-ordination of meal boluses and meals is difficult. Meal boluses without meals cause hypoglycemia; meals without meal boluses cause hyperglycemia. Different providers may use different methods of adjusting doses: some may use formulas of their own; some may use paper protocols that are complex and difficult for the nurse to follow, leading to a high incidence of human error; and some may use heuristic methods. There is no guarantee of consistency. Moreover, for diabetic patients who do not eat meals, there is no currently no computerized method of tracking the patient's status. For non-diabetic patient who get include due to "stress hyperglycemia" when they are very sick or undergoing surgery, there is no current method of monitoring their recovery when the stress subsides and their need for insulin rapidly decreases. If the dose regimen does not decrease rapidly also, hypoglycemia may result. Therefore, it is desirable to have a clinical support system <NUM> (<FIG> and <FIG>) that monitors patients' blood glucose level.

Referring to <FIG> and <FIG>, in some implementations, a clinical decision support system <NUM> analyzes inputted patient condition parameters for a patient <NUM> and calculates a personalized dose of insulin to bring and maintain the patient's blood glucose level into a target range BGTR. Moreover, the system <NUM> monitors the glucose levels of a patient <NUM> and calculates recommended intravenous or subcutaneous insulin dose to bring the patient's blood glucose into the preferred target range BGTR over a recommended period of time. A qualified and trained healthcare professional <NUM> may use the system <NUM> along with clinical reasoning to determine the proper dosing administered to a patient <NUM>. Therefore, the system <NUM> is a glycemic management tool for evaluation a patient's current and cumulative blood glucose value BG while taking into consideration the patient's information such as age, weight, and height. The system <NUM> may also consider other information such as carbohydrate content of meals, insulin doses being administered to the patient <NUM>, e.g., long-acting insulin doses for basal insulin and rapid-acting insulin doses for meal boluses and correction boluses. Based on those measurements (that may be stored in non-transitory memory <NUM>, <NUM>, <NUM>), the system <NUM> recommends an intravenous dosage of insulin, glucose, or saline or a subcutaneous basal and bolus insulin dosing recommendation or prescribed dose to adjust and maintain the blood glucose level towards a configurable (based on the patient's information) physician's determined blood glucose target range BGTR. The system <NUM> also considers a patient's insulin sensitivity or improved glycemic management and outcomes. The system <NUM> may take into account pertinent patient information such as demographics and previous results, leading to a more efficient use of healthcare resources. Finally, the system <NUM> provides a reporting platform for reporting the recommendations or prescribed dose(s) to the user <NUM> and the patient <NUM>. In addition, for diabetic patients who eat meals, the system <NUM> provides faster, more reliable, and more efficient insulin administration than a human monitoring the insulin administration. The system <NUM> reduces the probability of human error and insures consistent treatment, due to the system's capability of storing and tracking the patient's blood glucose levels BG, which may be used for statistical studies. As for patients who are tube-fed or do not eat meals, the system <NUM> provides dedicated subprograms, which in turn provide basal insulin and correction boluses but no meal boluses. Patients who are tube-fed or who do not eat usually have a higher basal insulin level than patients who eat, because the carbohydrates in the nutritive formula are accounted-for in the basal insulin. The system <NUM> provides a meal-by-meal adjustment of Meal Boluses without carbohydrate counting, by providing a dedicated subprogram that adjusts meal boluses based on the immediately preceding meal bolus and the BG that followed it. The system <NUM> provides a meal-by-meal adjustment of Meal Boluses with carbohydrate counting by providing a dedicated subprogram that adjusts meal boluses based a Carbohydrate-to-Insulin Ratio (CIR) that is adjusted at each meal, based on the CIR used at the immediately preceding meal bolus and the BG that followed it.

Hyperglycemia is a condition that exists when blood sugars are too high. While hyperglycemia is typically associated with diabetes, this condition can exist in many patients who do not have diabetes, yet have elevated blood sugar levels caused by trauma or stress from surgery and other complications from hospital procedures. Insulin therapy is used to bring blood sugar levels back into a normal range.

Hypoglycemia may occur at any time when a patient's blood glucose level is below a preferred target. Appropriate management of blood glucose levels for critically ill patients reduces co-morbidities and is associated with a decrease in infection rates, length of hospital stay, and death. The treatment of hyperglycemia may differ depending on whether or not a patient has been diagnosed with Type <NUM> diabetes mellitus, Type <NUM> diabetes mellitus, gestational diabetes mellitus, or non-diabetic stress hyperglycemia. The blood glucose target range BGTR is defined by a lower limit, i.e., a low target BGTRL and an upper limit, i.e., a high target BGTRH.

Stress-related hyperglycemia: Patients often get "stress hyperglycemia" if they are very sick or undergoing surgery. This condition requires insulin. In diabetic patients, the need for insulin is visibly increased. In non-diabetic patients, the stress accounts for the only need for insulin, and as the patients recover, the stress subsides, and their need for insulin rapidly decreases. For non-diabetic patients, the concern is that their need for insulin decreases faster than their dose regimen, leading to hypoglycemia.

Diabetes Mellitus has been treated for many years with insulin. Some recurring terms and phrases are described below:.

Bolus Insulin: Insulin that is administered in discrete doses. There are two main types of boluses, Meal Bolus and Correction Bolus.

Meal Bolus: Taken just before a meal in an amount which is proportional to the anticipated immediate effect of carbohydrates in the meal entering the blood directly from the digestive system. The amounts of the Meal Boluses may be determined and prescribed by a physician <NUM> for each meal during the day, i.e., breakfast, lunch, and dinner. Alternatively, the Meal Bolus may be calculated in an amount generally proportional to the number of grams of carbohydrates in the meal. The amount of the Meal Bolus is calculated using a proportionality constant, which is a personalized number called the Carbohydrate-to-Insulin Ratio (CIR) and calculated as follows: <MAT>.

Correction Bolus CB: Injected immediately after a blood glucose measurement; the amount of the correction bolus is proportional to the error in the BG (i.e., the bolus is proportional to the difference between the blood glucose measurement BG and the patient's personalized Target blood glucose BGTarget). The proportionality constant is a personalized number called the Correction Factor, CF, and is calculated as follows: <MAT>.

A Correction Bolus CB is generally administered in a fasting state, after the previously consumed meal has been digested. This often coincides with the time just before the next meal.

There are several kinds of Basal-Bolus insulin therapy including Insulin Pump therapy and Multiple Dose Injection therapy:.

Rapid-acting insulins act on a time scale shorter than natural insulin. They are appropriate for boluses.

In some examples, critically ill patients are ordered nil per os (NPO), which means that oral food and fluids are withheld from the patient <NUM>. Typically these patients <NUM> are unconscious, have just completed an invasive surgical procedure, or generally have difficulty swallowing. Intravenous insulin infusion is typically the most effective method of managing blood glucose levels in these patients. A patient <NUM> may be NPO and receiving a steady infusion of intravenous glucose, Total Parenteral Nutrition, tube feeding, regular meals that include carbohydrates, or not receiving any nutrition at all. In cases where the patient <NUM> is not receiving any nutrition, blood glucose is typically replaced by endogenous production by the liver.

As a patient's condition improves, an NPO order may be lifted, allowing the patient <NUM> to commence an oral caloric intake. In patients <NUM> with glycemic abnormalities, additional insulin may be needed to cover the consumption of carbohydrates. These patients <NUM> generally receive one-time injections of insulin in the patient's subcutaneous tissue.

Subcutaneous administration of mealtime insulin in critically ill patients <NUM> can introduce a patient safety risk if, after receiving the insulin injection, the patient <NUM> decides not to eat, is unable to finish the meal, or experiences emesis.

Continuous intravenous infusion of mealtime insulin, over a predetermined time interval, allows for an incremental fulfillment of the patient's mealtime insulin requirement, while minimizing patient safety risks. If a patient <NUM> decides he/she is unable to eat, the continuous intravenous infusion may be stopped or, if a patient <NUM> is unable to finish the meal, the continuous intravenous infusion rate may be decreased to compensate for the reduction in caloric intake.

The pharmacokinetics (what the body does to a drug over a period of time, which includes the processes of absorption, distribution, localization in tissues, biotransformation, and excretion) and pharmacodynamics (what a drug does to the body) actions of insulin significantly improve when administering insulin via an intravenous route, which is a typical method of delivery for hospitalized patients <NUM>. The management of prandial insulin requirements using an intravenous route can improve patient safety, insulin efficiency, and the accuracy of insulin dosing. The majority of patients who require continuous intravenous insulin infusion therapy may also need to be transitioned to a subcutaneous insulin regimen for ongoing control of blood glucose, regardless of diabetes mellitus (DM) diagnosis. Moreover, the timing, dosing, and process to transition patients <NUM> from a continuous intravenous route of insulin administration to a subcutaneous insulin regimen is complex and should be individualized based on various patient parameters. Failure to individualize this approach could increase the risk of severe hypoglycemia during the transition process. If not enough insulin is given, the patient <NUM> may experience acute post-transition hyperglycemia, requiring re-initiation of a continuous intravenous insulin infusion. Therefore, the clinical decision support system <NUM> calculates a personalized dose of insulin to bring and maintain the patient's blood glucose level into a target range BGTR, while taking into consideration the condition of the patient <NUM>.

The clinical decision support system <NUM> includes a glycemic management module <NUM>, an integration module <NUM>, a surveillance module <NUM>, and a reporting module <NUM>. Each module <NUM>, <NUM>, <NUM>, <NUM> is in communication with the other modules <NUM>, <NUM>, <NUM>, <NUM> via a network <NUM>. In some examples, the network <NUM> (discussed below) provides access to cloud computing resources that allows for the performance of services on remote devices instead of the specific modules <NUM>, <NUM>, <NUM>, <NUM>. The glycemic management module <NUM> executes a process <NUM> (e.g., an executable instruction set) on a processor <NUM>, <NUM>, <NUM> or on the cloud computing resources. The integration module <NUM> allows for the interaction of users <NUM> with the system <NUM>. The integration module <NUM> receives information inputted by a user <NUM> and allows the user <NUM> to retrieve previously inputted information stored on a storage system (e.g., one or more of cloud storage resources <NUM>, a non-transitory memory <NUM> of a hospital's electronic medical system <NUM>, a non-transitory memory <NUM> of the patient device <NUM>, or other non-transitory storage media in communication with the integration module <NUM>). Therefore, the integration module <NUM> allows for the interaction between the users <NUM> and the system <NUM> via a display <NUM>, <NUM>. The surveillance module <NUM> considers patient information 208a received from a user <NUM> via the integration module <NUM> and information received from a glucometer <NUM> that measures a patient's blood glucose value BG and determines if the patient <NUM> is within a threshold blood glucose value BGTH. In some examples, the surveillance module <NUM> alerts the user <NUM> if a patient's blood glucose values BG are not within a threshold blood glucose value BGTH. The surveillance module <NUM> may be preconfigured to alert the user <NUM> of other discrepancies between expected values and actual values based on pre-configured parameters (discussed below). For example, when a patient's blood glucose value BG drops below a lower limit of the threshold blood glucose value BGTHL. The reporting module <NUM> may be in communication with at least one display <NUM>, <NUM> and provides information to the user <NUM> determined using the glycemic management module <NUM>, the integration module <NUM>, and/or the surveillance module <NUM>. In some examples, the reporting module <NUM> provides a report that may be displayed on a display <NUM>, <NUM> and/or is capable of being printed.

The system <NUM> is configured to evaluate a glucose level and nutritional intake of a patient <NUM>. The system <NUM> also evaluates whether the patient <NUM> is transitioning to a subcutaneous insulin regime. Based on the evaluation and analysis of the data, the system <NUM> calculates an insulin dose, which is administered to the patient <NUM> to bring and maintain the blood glucose level of the patient <NUM> into the blood glucose target range BGTR. The system <NUM> may be applied to various devices, including, but not limited to, intravenous infusion pumps 123a, subcutaneous insulin infusion pumps 123a, glucometers, continuous glucose monitoring systems, and glucose sensors. In some implementations, as the system <NUM> is monitoring the patient's blood glucose values BG and the patient's insulin intake, the system <NUM> notifies the user <NUM> if the patient <NUM> receives more than <NUM> units/hour of insulin because the system <NUM> considers these patients <NUM> to be insulin resistant.

In some examples the clinical decision support system <NUM> includes a network <NUM>, a patient device <NUM>, a dosing controller <NUM>, and a service provider <NUM>. The patient device <NUM> may include, but is not limited to, desktop computers or portable electronic device (e.g., cellular phone, smartphone, personal digital assistant, barcode reader, personal computer, or a wireless pad) or any other electronic device capable of sending and receiving information via the network <NUM>.

The patient device <NUM> includes a data processor <NUM> (e.g., a computing device that executes instructions), and non-transitory memory <NUM> and a display <NUM> (e.g., touch display or non-touch display) in communication with the data processor <NUM>. In some examples, the patient device <NUM> includes a keyboard <NUM>, speakers <NUM>, microphones, mouse, and a camera.

The service provider <NUM> may include a data processor <NUM> in communication with non-transitory memory <NUM>. The service provider <NUM> provides the patient <NUM> with a process <NUM> (see <FIG>) (e.g., a mobile application, a web-site application, or a downloadable program that includes a set of instructions) executable on a processor <NUM>, <NUM>, <NUM> of the dosing controller <NUM> and accessible through the network <NUM> via the patient device <NUM>, intravenous infusion pumps 123a, hospital electronic medical record systems <NUM>, or portable blood glucose measurement devices <NUM> (e.g., glucose meter or glucometer). Intravenous infusion pumps infuse fluids, medication or nutrients into a patient's circulatory system. Intravenous infusion pumps 123a may be used intravenously and, in some instances, subcutaneous, arterial and epidural infusions are used. Intravenous infusion pumps 123a typically administer fluids that are expensive or unreliable if administered manually (e.g., using a pen 123b) by a nurse or doctor <NUM>. Intravenous infusion pumps 123a can administer a <NUM> per hour injection, injections every minute, injections with repeated boluses requested by the patient, up to a maximum number per hours, or fluids whose volumes vary by the time of day.

In some implementations, an electronic medical record system <NUM> is located at a hospital <NUM> (or a doctor's office) and includes a data processor <NUM>, a non-transitory memory <NUM>, and a display <NUM> (e.g., touch display or non-touch display). The transitory memory <NUM> and the display <NUM> are in communication with the data processor <NUM>. In some examples, the hospital electronic medical system <NUM> includes a keyboard <NUM> in communication with the data processor <NUM> to allow a user <NUM> to input data, such as patient information 208a (<FIG> and <FIG>). The non-transitory memory <NUM> maintains patient records capable of being retrieved, viewed, and, in some examples, modified and updated by authorized hospital personal on the display <NUM>.

The dosing controller <NUM> is in communication with the glucometer <NUM> and includes a computing device <NUM>, <NUM>, <NUM> and non-transitory memory <NUM>, <NUM>, <NUM> in communication with the computing device <NUM>, <NUM>, <NUM>. The dosing controller <NUM> executes the process <NUM>. The dosing controller <NUM> stores patient related information retrieved from the glucometer <NUM> to determine an insulin dose rate IRR based on the received blood glucose measurement BG.

The network <NUM> may include any type of network that allows sending and receiving communication signals, such as a wireless telecommunication network, a cellular telephone network, a time division multiple access (TDMA) network, a code division multiple access (CDMA) network, Global system for mobile communications (GSM), a third generation (<NUM>) network, fourth generation (<NUM>) network, a satellite communications network, and other communication networks. The network <NUM> may include one or more of a Wide Area Network (WAN), a Local Area Network (LAN), and a Personal Area Network (PAN). In some examples, the network <NUM> includes a combination of data networks, telecommunication networks, and a combination of data and telecommunication networks. The patient device <NUM>, the service provider <NUM>, and the hospital electronic medical record system <NUM> communicate with each other by sending and receiving signals (wired or wireless) via the network <NUM>. In some examples, the network <NUM> provides access to cloud computing resources, which may be elastic/on-demand computing and/or storage resources <NUM> available over the network <NUM>. The term 'cloud' services generally refers to a service performed not locally on a user's device, but rather delivered from one or more remote devices accessible via one or more networks <NUM>.

Referring to <FIG> and <FIG>, the process <NUM> receives parameters (e.g., patient condition parameters) inputted via the client device <NUM>, the service provider <NUM>, and/or the hospital system <NUM>, analyzes the inputted parameters, and determines a personalized dose of insulin to bring and maintain a patient's blood glucose level BG into a preferred target range BGTR.

In some implementations, before the process <NUM> begins to receive the parameters, the process <NUM> may receive a username and a password (e.g., at a login screen displayed on the display <NUM>, <NUM>) to verify that a qualified and trained healthcare professional <NUM> is initiating the process <NUM> and entering the correct information that the process <NUM> needs to accurately administer insulin to the patient <NUM>. The system <NUM> may customize the login screen to allow a user <NUM> to reset their password and/or username. Moreover, the system <NUM> may provide a logout button (not shown) that allows the user <NUM> to log out of the system <NUM>. The logout button may be displayed on the display <NUM>, <NUM> at any time during the execution of the process <NUM>.

The clinical decision support system <NUM> may include an alarm system <NUM> that alerts a user <NUM> when the patient's blood glucose level BG is outside the target range BGTR. The alarm system <NUM> may produce an audible sound via speaker <NUM> in the form of a beep or some like audio sounding mechanism. In some examples, the alarm system <NUM> displays a warning message or other type of indication on the display <NUM> of the patient device <NUM> to provide a warning message. The alarm system <NUM> may also send the audible and/or visual notification via the network <NUM> to the hospital system <NUM> (or any other remote station) for display on the display <NUM> of the hospital system <NUM> or played through speakers <NUM> of the hospital system <NUM>.

The process <NUM> prompts a user <NUM> to input patient information 208a at block <NUM>. The user <NUM> may input the patient information 208a, for example, via the user device <NUM> or via the hospital electronic medical record systems <NUM> located at a hospital <NUM> (or a doctor's office). The user <NUM> may input new patient information 208a as shown in <FIG> or retrieve previously stored patient information 208a as shown in <FIG>. In some implementations, the process <NUM> provides the user <NUM> with a patient list <NUM> (<FIG>) where the user <NUM> selects one of the patient names from the patient list <NUM>, and the process <NUM> retrieves that patient's information 208a. The process <NUM> may allow the user <NUM> to filer the patient list <NUM>, e.g., alphabetically (first name or last name), by location, patient identification. The process <NUM> may retrieve the patient information 208a from the non-transitory memory <NUM> of the hospital's electronic medical system <NUM> or the non-transitory memory <NUM> of the patient device <NUM> (e.g., where the patient information 208a was previously entered and stored). The patient information 208a may include, but is not limited to, a patient's name, a patient's identification number (ID), a patient's height, weight, date of birth, diabetes history, physician name, emergency contact, hospital unit, diagnosis, gender, room number, and any other relevant information. In some examples, the diagnosis may include, but is not limited to, burn patients, Coronary artery bypass patients, stoke patients, diabetic ketoacidosis (DKA) patients, and trauma patients. After the user <NUM> completes inputting the patient information 208a, the process <NUM> at block <NUM> determines whether the patient <NUM> is being treated with an intravenous treatment module by prompting the user <NUM> (e.g., on the display <NUM>, <NUM>) to input whether the patient <NUM> will be treated with an intravenous treatment module. If the patient <NUM> will not be treated with the intravenous treatment module, the process <NUM> determines at block <NUM> whether the patient <NUM> will be treated with a subcutaneous treatment module, by asking the user <NUM> (e.g., by prompting the user <NUM> on the display <NUM>, <NUM>). If the user <NUM> indicates that the patient <NUM> will be treated with the subcutaneous treatment, the process <NUM> flows to block <NUM>, where the user <NUM> enters patient subcutaneous information 216a, such as bolus insulin type, target range, basal insulin type and frequency of distribution (e.g., <NUM> does per day, <NUM> doses per day, <NUM> doses per day, etc.), patient diabetes status, subcutaneous type ordered for the patient (e.g., Basal/Bolus and correction that is intended for patients on a consistent carbohydrate diet, or Basal and correction that is intended for patients who are NPO or on continuous enteral feeds), frequency of patient blood glucose measurements, or any other relevant information. In some implementations, the patient subcutaneous information 216a is prepopulated with default parameters, which may be adjusted or modified. When the user <NUM> enters the patient subcutaneous information <NUM>, the subcutaneous program begins at block <NUM>. The process may determine whether the patient <NUM> is being treated with an intravenous treatment or a subcutaneous treatment by prompting the user <NUM> to select between two options (e.g., a button displayed on the display <NUM>, <NUM>), one being the intravenous treatment and the other begin the subcutaneous treatment.

In some implementations and referring back to block <NUM>, if the process <NUM> determines that the patient <NUM> will be treated with the intravenous treatment module, the process <NUM> prompts the user <NUM> at block <NUM> for setup data 204a, such as patient parameters 204a relevant to the intravenous treatment mode. In some examples, the patient parameter 204a relating to the intravenous treatment may be prepopulated, for example, with default values that may be adjusted and modified by the user <NUM>. These patient parameters 204a may include an insulin concentration (i.e., the strength of insulin being used for the intravenous dosing, which may be measured in units/milliliter), the type of insulin and rate being administered to the patient, the blood glucose target range BGTR, the patient's diabetes history, a number of carbohydrates per meal, or any other relevant information. In some implementations, the type of insulin and the rate of insulin depend on the BG of the patient <NUM>. For example, the rate and type of insulin administered to a patient <NUM> when the blood glucose value BG of the patient <NUM> is greater or equal to 250mgl/dl may be different than the rate and type of insulin administered to the patient <NUM> when the blood glucose value BG of the patient is greater than <NUM>/dl. The blood glucose target range BGTR may be a configurable parameter, customized based on various patient factors. The blood glucose target range BGTR may be limited to <NUM>/dl (e.g., <NUM>-<NUM>/dl, <NUM>-<NUM>/dl, and <NUM>-<NUM>/dl).

After the user <NUM> inputs patient parameters 204a for the intravenous treatment at block <NUM>, the process <NUM> prompts the user <NUM> to input the blood glucose value BG of the patient <NUM> at block <NUM>. The blood glucose value BG may be manually inputted by the user <NUM>, sent via the network <NUM> from a glucometer <NUM>, sent electronically from the hospital information or laboratory system <NUM>, or other wireless device. The process <NUM> determines a personalized insulin dose rate, referred to as an insulin infusion rate IIR, using the blood glucose value BG of the patient <NUM> and a dose calculation process <NUM>.

In some implementations, the process <NUM> executes on the processor <NUM>, <NUM>, <NUM> the following instruction set. Other instructions are possible as well. <IMG>
<IMG>
<IMG>
<IMG>
<IMG>
<IMG>
<IMG>
<IMG>
<IMG>.

<FIG> provides a dose calculation process <NUM> for calculating the insulin infusion rate IIR of the patient <NUM> for intravenous treatment after the process <NUM> receives the patient information 208a discussed above (including the patients' blood glucose value BG). At block <NUM> the dose calculation process <NUM> determines if the patient's blood glucose BG is less than a stop threshold value BGTHstop. If not, then at block <NUM> the dose calculation process <NUM> goes to block <NUM> without taking any action. If, however, the patient's blood glucose BG is less than a stop threshold value BGTHstop, then the calculation dose process sets the patient's regular insulin dose rate IRR to zero at block <NUM>, which then goes to block <NUM>. The dose calculation process <NUM> determines at decision block <NUM> if the inputted blood glucose value BG is the first inputted blood glucose value.

The patient's regular insulin dose rate IIR is calculated at block <NUM> in accordance with the following equation: <MAT> where K is a constant, known as the Offset Target, with the same unit of measure as blood glucose and M is a unit-less multiplier. In some examples, the Offset Target K is lower than the blood glucose target range of the patient <NUM>. The Offset Target K allows the dose calculation process <NUM> to calculate a non-zero stable insulin dose rate even with a blood glucose result is in the blood glucose target range BGTR.

The initial multiplier MI, determined by the physician <NUM>, approximates the sensitivity of a patient <NUM> to insulin. For example, the initial multiplier equals <NUM> for adults ages <NUM> and above. In some examples, the initial multiplier MI equals <NUM> for frail elderly patients <NUM> who may be at risk for complications arising when their blood glucose level BG falls faster than <NUM>/dl/hr. Moreover, the physician <NUM> may order a higher initial multiplier MI for patients <NUM> with special needs, such as CABG patients (i.e., patients who have undergone coronary artery bypass grafting) with BMI (Body Mass Index which is a measure for the human body shape based on the individual's mass and height) less than <NUM> might typically receive an initial multiplier of <NUM>, whereas a patient <NUM> with BMI greater than <NUM> might receive an initial multiplier MI of <NUM>. In addition, a patient's weight may be considered in determining the value of the initial multiplier MI, for examples, in pediatric treatments, the system <NUM> calculates a patient's initial multiplier MI using the following equation: <MAT> In some implementations, K is equal to <NUM>/dl. The dose calculation process <NUM> determines the target blood glucose target range BGTR using two limits inputted by the user <NUM>, a lower limit of the target range BGTRL and an upper (high) limit of the target range BGTRH. These limits are chosen by the user <NUM> so that they contain the desired blood glucose target as the midpoint. Additionally, the Offset Target K may be calculated dynamically in accordance with the following equation: <MAT> where BGTarget is the midpoint of the blood glucose target range BGTR and Offset is the preconfigured distance between the target center BGTarget and the Offset Target, K.

In some implementations, the insulin dose rate IRR may be determined by the following process on a processor <NUM>, <NUM>, <NUM>. Other processes may also be used. <IMG>
<IMG>.

Referring to decision block <NUM>, when the dose calculation process <NUM> determines that the inputted blood glucose value BG is the first inputted blood glucose value, then the dose calculation process <NUM> defines the value of the current multiplier M equal to an initial multiplier (MI) at block <NUM>. The dose calculation process <NUM> then calculates, at block <NUM>, the Insulin Infusion Rate in accordance with the IIR equation (EQ. 3A) and returns to the process <NUM> (see <FIG>).

However, referring back to decision block <NUM>, when the dose calculation process <NUM> determines that the inputted blood glucose value BG is not the first inputted blood glucose value, the dose calculation process <NUM> determines if the Meal Bolus Module has been activated at decision block <NUM>. If the dose calculation process <NUM> determines that the Meal Bolus Module has been activated, then the dose calculation process <NUM> begins a Meal Bolus process <NUM> (see <FIG>).

Referring back to decision block <NUM>, if the Meal Bolus Module has not been activated, the dose calculation process <NUM> determines, at decision block <NUM>, if the current blood glucose value BG is greater than the upper limit BGTRH of the blood glucose target range BGTR. If the blood glucose value BG is greater than the upper limit BGTRH of the blood glucose target range BGTR, the dose calculation process <NUM> determines, at block <NUM>, a ratio of the current blood glucose value BG to the previous blood glucose value BGP, where BGP was measured at an earlier time than the current BG. The process <NUM> then determines if the ratio of the blood glucose to the previous blood glucose, BG/BGP , is greater than a threshold value LA, as shown in the following equation: <MAT> where BG is the patient's current blood glucose value; BGP is the patient's previous blood glucose value; and LA is the threshold ratio of BG/BGP for blood glucose values above the upper limit of the blood glucose target range BGTRH. If the ratio BG/BGP exceeds the threshold ratio LA , then the Multiplier M is increased. In some examples, the threshold ratio LA equals <NUM>.

If the dose calculation process <NUM> determines that the ratio (BG/ BGp) of the blood glucose value BG to the previous blood glucose value BGp is not greater than the threshold ratio LA for a blood glucose value BG above the upper limit BGTRH of the blood glucose target range BGTR, then the dose calculation process <NUM> sets the value of the current multiplier M to equal the value of the previous multiplier MP, see block <NUM>.

Referring back to block <NUM>, if the dose calculation process <NUM> determines that the ratio (BG/BGp) of the blood glucose value BG to the previous blood glucose BGP is greater than the threshold ratio LA for a blood glucose value above upper limit BGTRH of the blood glucose target range BGTR, then dose calculation process <NUM> multiplies the value of the current multiplier M by a desired Multiplier Change Factor (MCF) at block <NUM>. The dose calculation process <NUM> then calculates the insulin infusion rate at block <NUM> using the IIR equation (EQ. 3A) and returns to the process <NUM> (see <FIG>).

Referring back to block <NUM>, when the dose calculation process <NUM> determines that the current blood glucose value BG is not greater than the upper limit BGTRH of the blood glucose target range BGTR, the dose calculation process <NUM> then determines if the current blood glucose concentration BG is below the lower limit BGTRL of the blood glucose target range BGTR at decision block <NUM>. If the current blood glucose value BG is below the lower limit BGTRL of the blood glucose target range BGTR, the dose calculation process <NUM> at block <NUM> divides the value of the current multiplier M by the Multiplier Change Factor (MCF), in accordance with the following equation: <MAT> and calculates the current insulin infusion rate IIR using equation <NUM> at block <NUM> and returns to the process <NUM> (see <FIG>).

At block <NUM>, if the dose calculation process <NUM> determines that the blood glucose value BG is not below the lower limit of the blood glucose target range BGTRL, the dose calculation process <NUM> sets the value of the current multiplier to be equal to the value of the previous multiplier MP at block <NUM> (see EQ.

Referring again to <FIG>, at block <NUM>, if the current blood glucose value BG is below the lower limit of the target range BGTRL, logic passes to decision block <NUM>, where the process <NUM> determines if the current blood glucose concentration BG is below a hypoglycemia threshold BGHypo. If the current blood glucose BG is below the hypoglycemia threshold BGHypo, logic then passes to block <NUM>, where the process <NUM> recommends hypoglycemia treatment, either by a calculation of an individualized dose of intravenous glucose or oral hypoglycemia treatment.

Referring back to <FIG>, after the dose calculation process <NUM> calculates the insulin infusion rate IIR, the process <NUM> proceeds to a time calculation process <NUM> (<FIG>) for calculating a time interval TNext until the next blood glucose measurement.

<FIG> shows the time interval calculation process <NUM> for calculating a time interval TNext between the current blood glucose measurement BG and the next blood glucose measurement BGnext. The time-duration of blood glucose measurement intervals TNext may vary and the starting time interval can either be inputted by a user <NUM> at the beginning of the process <NUM>, <NUM>, <NUM>, or defaulted to a predetermined time interval, TDefault (e.g., one hour). The time interval TNext is shortened if the blood glucose concentration BG of the patient <NUM> is decreasing excessively, or it may be lengthened if the blood glucose concentration BG of the patient <NUM> becomes stable within the blood glucose target range BGTR.

The time-interval calculation process <NUM> determines a value for the time interval TNext based on several conditions. The time-interval process <NUM> checks for the applicability of several conditions, where each condition has a value for Tnext that is triggered by a logic-test (except Tdefault). The process <NUM> selects the lowest value of Tnext from the values triggered by logic tests (not counting Tdefault). If no logic test was triggered, the process selects Tdefault. This is accomplished in <FIG> by the logic structure that selects the lowest values of Tnext first. However, other logic structures are possible as well.

The time calculation process <NUM> determines at decision block <NUM> if the current blood glucose BG is below the lower limit BGTRL (target range low limit) of the blood glucose target range BGTR. If the current blood glucose BG is below the lower limit BGTRL of the blood glucose target range BGTR, then the time calculation process <NUM> determines, at decision block <NUM>, if the current blood glucose BG is less than a hypoglycemia-threshold blood glucose level BGHypo.

If the current blood glucose BG is less than the hypoglycemia-threshold blood glucose level BGHypo the time calculation process <NUM> sets the time interval TNext to a hypoglycemia time interval THypo, e.g., <NUM> or <NUM> minutes, at block <NUM>. Then the time calculation process <NUM> is complete and returns to the process <NUM> (<FIG>) at block <NUM>.

If the current blood glucose BG is not less than (i.e., is greater than) the hypoglycemia-threshold blood glucose level BGHypo at block <NUM>, the time calculation process <NUM> determines at block <NUM> if the most recent glucose percent drop BG%Drop, is greater than the threshold glucose percentage drop %DropLow Limit (for a low BG range) using the following equation: <MAT> since <MAT> then, <MAT> where BGP is a previously measured blood glucose.

If the current glucose percent drop BG%Drop, is not greater than the limit for glucose percent drop (for the low BG range) %DropLow Limit, the time calculation process <NUM> passes the logic to block <NUM>. In some examples, the low limit %DropLow Limit equals <NUM>%.

Referring back to block <NUM>, if the current glucose percent drop BG%Drop is greater than the limit for glucose percent drop (for the low BG range) %DropLow Limit, the time calculation process <NUM> at block <NUM> sets the time interval to a shortened time interval TShort, for example <NUM> minutes, to accommodate for the increased drop rate of the blood glucose BG. Then the time calculation process <NUM> is complete and retums to the process <NUM> (<FIG>) at block <NUM>.

Referring back to decision block <NUM>, if the time calculation process <NUM> determines that the current blood glucose BG is not below the lower limit BGTRL for the blood glucose target range BGTR, the time calculation process <NUM> determines at block <NUM> if the blood glucose BG has decreased by a percent of the previous blood glucose that exceeds a limit %DropRegular (for the regular range, i.e., blood glucose value BG > BGTRL), using the formula: <MAT>.

If the blood glucose BG has decreased by a percentage that exceeds the regular threshold glucose percent drop (for the regular BG range) %DropRegular, the time calculation process <NUM>, at block <NUM>, sets the time interval to the shortened time interval TShort, for example <NUM> minutes. A reasonable value for %DropRegular for many implementations is <NUM>%. Then the time calculation process <NUM> is complete and returns to the process <NUM> (<FIG>) at block <NUM>. If, however, the glucose has not decreased by a percent that exceeds the threshold glucose percent drop %DropRegular, (for the regular BG range), the time calculation process <NUM> routes the logic to block <NUM>. The process <NUM> determines, at block <NUM>, a blood glucose rate of descent BGDropRate based on the following equation: <MAT> where BGP is the previous blood glucose measurement, TCurrent is the current time and TPrevious is the previous time. Moreover, the process <NUM> at block <NUM> determines if the blood glucose rate of descent BGDropRate is greater than a preconfigured drop rate limit BGdropRateLimit.

If the time calculation process <NUM> at block <NUM> determines that the blood glucose rate of descent BGDropRate, has exceeded the preconfigured drop rate limit BGdropRateLimit, the time interval TNext until the next blood glucose measurement is shortened at block <NUM> to a glucose drop rate time interval TBGDR, which is a relatively shorter time interval than the current time interval TCurrent, as consideration for the fast drop. The preconfigured drop rate limit BGdropRateLimit may be about <NUM>/dl/hr. The glucose drop rate time interval TBGDR may be <NUM> minutes, or any other predetermined time. In some examples, a reasonable value for TDefault is one hour. Then the time calculation process <NUM> is complete and returns to the process <NUM> (<FIG>) at block <NUM>.

If the time calculation process <NUM> determines at block <NUM> that the glucose drop rate BGDropRate does not exceed the preconfigured rate limit BGdropRateLimit, the time calculation process <NUM> determines, at block <NUM>, if the patient's blood glucose concentration BG has been within the desired target range BGTR (e.g., BGTRL <BG< BGTRH) for a period of time TStable. The criterion for stability in the blood glucose target range BGTR is a specified time in the target range BGTR or a specified number of consecutive blood glucose measurements in the target range BGTR. For example, the stable period of time TStable may be one hour, two hours, two and a half hours, or up to <NUM> hours. If the stability criterion is met then the time interval TNext until the next scheduled blood glucose measurement BG may be set at block <NUM> to a lengthened time interval TLong (such as <NUM> hours) that is generally greater than the default time interval TDefault. Then the time calculation process <NUM> is complete and returns to the process <NUM> (<FIG>) at block <NUM>. If the time calculation process <NUM> determines that the patient <NUM> has not met the criteria for stability, the time calculation process <NUM> sets the time interval TNext to a default time interval TDefault at block <NUM>. Then the time calculation process <NUM> is complete and returns to the process <NUM> (<FIG>) at block <NUM>.

Referring to <FIG>, once the time calculation process <NUM> calculates the recommended time interval TNext, the process <NUM> provides a countdown timer <NUM> that alerts the user <NUM> when the next blood glucose measurement is due. The countdown timer <NUM> may be on the display <NUM> of the patient device <NUM> or displayed on the display <NUM> of the hospital system <NUM>. When the timer <NUM> is complete, a "BG Due!" message might be displayed as shown in <FIG>. The countdown timer <NUM> may include an overdue time <NUM> indicating the time late if a blood glucose value is not entered as scheduled.

In some implementations, the countdown timer <NUM> connects to the alarm system <NUM> of the user device <NUM>. The alarm system <NUM> may produce an audible sound via the speaker <NUM> in the form of a beep or some like audio sounding mechanism. The audible and/or visual notification may also be sent via the network to the hospital system <NUM> (or any other remote station) and displayed on the display <NUM> of the hospital system <NUM> or played through speakers <NUM> of the hospital system <NUM>, or routed to the cell phone or pager of the user. In some examples, the audible alarm using the speakers <NUM> is turned off by a user selection <NUM> on the display <NUM> or it is silenced for a preconfigured time. The display <NUM>, <NUM> may show information <NUM> that includes the patient's intravenous treatment information 230a or to the patient's subcutaneous treatment information 230b. In some examples, the user <NUM> selects the countdown timer <NUM> when the timer <NUM> indicates that the patient <NUM> is due for his or her blood glucose measurement. When the user <NUM> selects the timer <NUM>, the display <NUM>, <NUM> allows the user <NUM> to enter the current blood glucose value BG as shown in <FIG>. For intravenous patients <NUM>, the process <NUM> may ask the user <NUM> (via the display <NUM>, <NUM>) if the blood glucose is pre-meal blood glucose measurement (as shown in <FIG>). When the user <NUM> enters the information <NUM> (<FIG>), the user <NUM> selects a continue button to confirm the entered information <NUM>, which leads to the display <NUM>, <NUM> displaying blood glucose information 230c and a timer <NUM> showing when the next blood glucose measurement BG is due (<FIG>). In addition, the user <NUM> may enter the patient's blood glucose measurement BG at any time before the timer <NUM> expires, if the user <NUM> selects the 'enter BG' button <NUM>. Therefore, the user <NUM> may input blood glucose values BG at any time, or the user <NUM> may choose to start the Meal Bolus module process <NUM> (see <FIG>) by selecting the start meal button <NUM> (<FIG>), transition the patient to SubQ insulin therapy <NUM> (see <FIG>), or discontinue treatment <NUM>.

Referring to <FIG>, in some implementations, the process <NUM> includes a process where the patient's blood glucose level BG is measured prior to the consumption of caloric intake and calculates the recommended intravenous mealtime insulin requirement necessary to control the patient's expected rise in blood glucose levels during the prandial period. When a user <NUM> chooses to start the Meal Bolus process <NUM> (e.g., when the user <NUM> positively answers that this is a pre-meal blood glucose measurement in <FIG>, or when the user <NUM> selects the start meal button <NUM> in <FIG>), the Meal Bolus process <NUM>, at decision block <NUM>, requests the blood glucose BG of the patient <NUM> (as shown in <FIG>). The user <NUM> enters the blood glucose value BG at <NUM> or the system <NUM> receives the blood glucose BG from a glucometer <NUM>. This blood glucose measurement is referred to herein as the Pre-Meal BG or BG1. In some examples, where the user <NUM> enters the information, the user <NUM> selects a continue button to confirm the entered information 230c. In some examples, the intravenous meal bolus process <NUM> is administered to a patient <NUM> over a total period of time TMealBolus. The total period of time TMealBolus is divided into multiple time intervals TMealBolus1 to TMealBolusN, where N is any integer greater than zero. In some examples, a first time interval TMealBolus1 runs from a Pre-Meal blood glucose value BG1 at measured at time T<NUM>, to a second blood glucose value BG2 at measured at time T<NUM>. A second time interval TMealBolus2 runs from the second blood glucose value BG2 measured at time T<NUM> to the third blood glucose value BG3 measured at time T<NUM>. A third time interval TMealBolus3 runs from the third blood glucose value BG3 measured at time T<NUM> to a fourth blood glucose value BG4 measured at time T<NUM>. In some implementations where the time intervals TMealBolusN are smaller than TDefault , the user <NUM> should closely monitor and control over changes in the blood glucose of the patient <NUM>. For example, a total period of time TMealBolus equals <NUM> hours, and may be comprised of: TMealBolus1 = <NUM> minutes, TMealBolus2 = <NUM> minutes, and TMealBolus3 = <NUM> hour. This example ends on the fourth blood glucose measurement. When the Meal Bolus process <NUM> has been activated, an indication <NUM> is displayed on the display <NUM>, <NUM> informing the user <NUM> that the process <NUM> is in progress. The Meal Bolus process <NUM> prompts the user <NUM> if the entered blood glucose value BG is the first blood glucose value prior to the meal by displaying a question on the patient display <NUM>. If the Meal Bolus process <NUM> determines that the entered blood glucose value BG is the first blood glucose value (BG1) prior to the meal, then the Meal Bolus process <NUM> freezes the current multiplier M from being adjusted and calculates a regular intravenous insulin rate IRR at block <NUM>. The regular intravenous insulin rate IRR may be determined using EQ. Meanwhile, at block <NUM>, the Meal Bolus process <NUM> loads preconfigured meal parameters, such as meal times, insulin type, default number of carbohydrates per meal, the total period of time of the meal bolus process TMealBolus, interval lengths (e.g., TMealBolusl1 TMealBolus1. TMealBolusN), and the percent, "C", of the estimated meal bolus to be delivered in the first interval TMealBolus1. In some examples, when the system <NUM> includes a hospital electronic medical record system <NUM>, nutritional information and number of grams of carbohydrates are retrieved from the hospital electronic medical record systems <NUM> automatically. The Meal Bolus process <NUM> allows the user <NUM> to select whether to input a number of carbohydrates from a selection of standard meals (AcutalCarbs) or to use a custom input to input an estimated number of carbohydrates (EstimatedCarbs) that the patient <NUM> is likely to consume. The Meal Bolus process <NUM> then flows to block <NUM>, where the estimated meal bolus rate for the meal is calculated. The calculation process in block <NUM> is explained in two steps. The first step is calculation of a meal bolus (in units of insulin) in accordance with the following equation: <MAT> where CIR is the Carbohydrate-to-Insulin Ratio, previously discussed.

The Meal Bolus process <NUM> then determines the Estimated Meal Bolus Rate based on the following equation: <MAT> Where, TMealBolus1 is the time duration of the first time interval of the Meal Bolus total period of time TMealBolus. C is a constant adjusted to infuse the optimum portion of the Estimated Meal Bolus during first time interval TMealBolus1. For instance: if Estimated Meal Bolus = <NUM> units, TMealBolus1 = <NUM> hours, and C = <NUM>%, then applying Eq. 11A as an example: <MAT> The Meal Bolus process <NUM> calculates the Total Insulin Rate at block <NUM> as follows: <MAT>.

The Meal Bolus process <NUM> flows to block <NUM> where it sets the time interval for the first interval TMealBolus1 to its configured value, (e.g., usually <NUM> minutes), which will end at the second meal bolus blood glucose (BG2).

After the first time interval TMealBolus1 expires (e.g., after <NUM> minutes elapse), the Meal Bolus process <NUM> prompts the user <NUM> to enter the blood glucose value BG once again at block <NUM>. When the Meal Bolus process <NUM> determines that the entered blood glucose value BG is not the first blood glucose value BG1 entered at block <NUM> (i.e., the pre-meal BG, BG1, as previously discussed), the process <NUM> flows to block <NUM>. At block <NUM>, the Meal Bolus process <NUM> determines if the blood glucose value BG is the second value BG2 entered by the user <NUM>. If the user <NUM> confirms that the entered blood glucose value BG is the second blood glucose value BG2 entered, the Meal Bolus process <NUM> uses the just-entered blood glucose BG2 to calculate the intravenous insulin rate IRR at block <NUM> and flows to block <NUM>. Simultaneously, if the blood glucose is the second blood glucose BG2, the Meal Bolus process <NUM> prompts the user <NUM> to enter the actual amount of carbohydrates that the patient <NUM> received at block <NUM>. The Meal Bolus process <NUM> then determines at decision block <NUM> and based on the inputted amount of actual carbohydrates, if the patient did not eat, i.e., if the amount of carbohydrates is zero (see <FIG>). If the Meal Bolus process <NUM> determines that the patient did not eat, the Meal Bolus process <NUM> then flows to block <NUM>, where the meal bolus module process <NUM> is discontinued, the multiplier is no longer frozen, and the time interval TNext is restored to the appropriate time interval TNext, as determined by process <NUM>. If however, the Meal Bolus process <NUM> determines that the patient <NUM> ate, i.e., the actual carbohydrates is not zero (see <FIG>), then The Meal Bolus process <NUM> flows to block <NUM>, where it calculates a Revised meal bolus rate according to the following equations, where the Revised Meal Bolus and then an amount of insulin (in units of insulin)are calculated: <MAT>.

The process at block <NUM> then determines the amount (in units of insulin) of estimated meal bolus that has been delivered to the patient <NUM> so far: <MAT> where time T1 is the time of when the first blood glucose value BG1 is measured and time T2 is the time when the second blood glucose value BG2 is measured.

The process at block <NUM> then calculates the portion of the Revised Meal Bolus remaining to be delivered (i.e., the Meal Bolus that has not yet been delivered to the patient <NUM>) as follows: <MAT>.

The process at block <NUM> then calculates the Revised Meal Bolus Rate as follows: <MAT> where Time Remaining = TMealBolus - TMealBolus1. Since the total time interval TMealBolus and the first time interval TMealBolus1 are preconfigured values, the Time Remaining may be determined.

The Meal Bolus process <NUM> calculates the total insulin rate at block <NUM> by adding the Revised Meal Bolus Rate to the regular Intravenous Rate (IIR), based on the blood glucose value BG: <MAT>.

The Meal Bolus process <NUM> flows to block <NUM> where it sets the time interval TNext to the second interval TMealBolus2, which will end at the third meal bolus blood glucose BG3 e.g., usually <NUM> minutes.

After the second interval, TMealBolus2 expires (e.g., <NUM> minutes), the Meal Bolus process <NUM> prompts the user <NUM> to enter the blood glucose value BG once again at block <NUM>. The Meal Bolus process <NUM> determines that the entered blood glucose value BG is not the first blood glucose value entered at block <NUM> (previously discussed) and flows to block <NUM>. The Meal Bolus process <NUM> determines that the entered blood glucose value BG is not the second blood glucose value entered at block <NUM> (previously discussed) and flows to block <NUM>. At block <NUM>, the Meal Bolus process <NUM> determines if the blood glucose value BG is the third value entered. If the entered blood glucose value BG is the third blood glucose value BG entered, the Meal Bolus process <NUM> calculates the intravenous insulin rate IRR at block <NUM> and flows to block <NUM>.

At block <NUM> the process determines the Total Insulin Rate by adding the newly-determined Regular Intravenous Insulin Rate (IIR) to the Revised Meal Bolus Rate, which was determined at BG2 and remains effective throughout the whole meal bolus time, Tmealbolus.

The Meal Bolus process <NUM> flows to block <NUM> where it sets the time interval TNext to the third interval TMealBolus3 for the fourth meal bolus blood glucose, e.g., usually <NUM> minutes. In some implementations, more than <NUM> intervals (TMealBolus1, TMealBolus2 TMealBolus3) may be used. Additional intervals TMealBolusN may also be used and the process handles the additional intervals TMealBolusN similarly to how it handles the third time interval TMealBolus3. As discussed in the current example, the third interval TMealBolus3 is the last time interval, which ends with the measurement of the fourth blood glucose measurement BG4.

After the third time interval, TMealBolus3, expires (e.g., <NUM> minutes), the Meal Bolus process <NUM> prompts the user <NUM> to enter the blood glucose value BG once again at block <NUM>. The Meal Bolus process <NUM> determines that the entered blood glucose value BG is not the first blood glucose value entered at block <NUM> (previously discussed) and flows to block <NUM>. The Meal Bolus process <NUM> determines that the entered blood glucose value BG is not the second blood glucose value entered at block <NUM> (previously discussed), nor the third blood glucose level entered at block <NUM> and flows to block <NUM>. At block <NUM>, the Meal Bolus process <NUM> determines that the inputted blood glucose is the fourth blood glucose valueBG4. In this example, the fourth blood glucose value BG4 is the last one. The process <NUM> then flows to block <NUM> where the multiplier is no longer frozen, and the time interval TNext is restored to the appropriate time interval TNext, as determined by the Timer Adjustment process <NUM> (<FIG>). At this time, the Meal Bolus process <NUM> ends and the user <NUM> is prompted with a message indicating that the Meal Bolus process <NUM> is no longer active.

As shown in <FIG>, and previously discussed with respect to <FIG>, the process <NUM> provides a countdown timer <NUM> that alerts the user <NUM> when the next blood glucose measurement is due. The countdown timer <NUM> may be on the display <NUM> of the patient device <NUM> or displayed on the display <NUM> of the hospital system <NUM>. When the timer <NUM> is complete, a "BG Due!" message might be displayed as shown in <FIG>. Moreover, the timer <NUM> may be a countdown timer or a meal timer indicating a sequence of mealtime intervals (e.g., breakfast, lunch, dinner, bedtime, mid-sleep).

In some implementations, a Meal Bolus process <NUM> may be implemented by the following process on a processor <NUM>, <NUM>, <NUM>. Other processes may also be used. <IMG>
<IMG>
<IMG>.

Referring to <FIG> and <FIG>, if the user elects to initiate the SubQ Transition process <NUM>, the SubQ Transition process <NUM> determines at decision block <NUM> if the current blood glucose BG is within a preconfigured stability target range BGSTR, e.g., <NUM>-<NUM>/dl, which is usually wider than the prescribed Target Range, BGTR. If the blood glucose BG is not within the preconfigured stability target range BGSTR (e.g., BGLow < BG < BGHigh), the SubQ Transition process <NUM> at block <NUM> displays a warning notification on the patient display <NUM>. Then, at block <NUM>, the SubQ Transition process <NUM> is automatically discontinued.

Referring back to block <NUM>, if the blood glucose BG is within the preconfigured stability target range BGSTR (e.g. <NUM> - <NUM>/dl), the SubQ Transition process <NUM> at decision block <NUM> determines if the patient's blood glucose measurement BG has been in the patient's personalized prescribed target range BGTR for the recommended stability period TStable, e.g., <NUM> hours. If the SubQ Transition process <NUM> determines that the blood glucose value BG has not been in the prescribed target range BGSTR for the recommended stability period TStable, the SubQ Transition process <NUM> moves to block <NUM> where the system <NUM> presents the user <NUM> with a warning notification on the patient display <NUM>, explaining that the patient <NUM> has not been in the prescribed target range for the recommended stability period (see <FIG>). The SubQ Transition process <NUM> continues to decision block <NUM> where it determines whether the user <NUM> wants the patient <NUM> to continue the SubQ Transition process or to discontinue the SubQ Transition process. The SubQ Transition process <NUM> displays on the display <NUM> of the patient device <NUM> the question to the user <NUM> as shown in <FIG>. If the user <NUM> chooses to discontinue the SubQ Transition process, the SubQ Transition process <NUM> flows to block <NUM>, where the SubQ Transition process is discontinued.

Referring back to block <NUM>, if the user <NUM> chooses to override the warning and continue the SubQ Transition process, the process <NUM> prompts the user <NUM> to enter SubQ information <NUM>. The SubQ Transition process <NUM> flows to block <NUM>, where the patient's SubQ Transition dose is calculated as a patient's total daily dose TDD. In some implementations, TDD is calculated in accordance with equation: <MAT> where QuickTransitionConstant is usually <NUM>, and MTrans is the patient's multiplier at the time of initiation of the SubQ transition process.

Referring again to block <NUM>, in some implementations TDD is calculated by a statistical correlation of TDD as a function of body weight. The following equation is the correlation used: <MAT>.

The SubQ Transition process <NUM> continues to block <NUM>, where the recommended SubQ dose is presented to the user <NUM> (on the display <NUM>) in the form of a Basal recommendation and a Meal Bolus recommendation (see <FIG>).

Referring again to decision block <NUM>, if the SubQ Transition process <NUM> determines that the patient <NUM> has been in the prescribed target range BGTR for the recommended stability period, TStable, SubQ Transition process <NUM> continues to block <NUM>, where the patient's total daily dose TDD is calculated in accordance with the following equation: <MAT> where MTrans is the patient's multiplier at the time of initiation of the SubQ transition process.

In some implementations, the patient's total daily dose TDD may be determined by the following process on a processor <NUM>, <NUM>, <NUM>. Other processes may also be used.

When the patient's total daily dose TDD is calculated, the SubQ Transition process <NUM> continues to block <NUM> where the recommended SubQ dose is presented to the user <NUM> as described above. The SubQ Transition process <NUM> continues to block <NUM>, where the SubQ Transition process <NUM> provides information to the user <NUM> including a recommended dose of Basal insulin. The user <NUM> confirms that the Basal insulin has been given to the patient <NUM>; this starts a transitions timer using the TransitionRunTimeNext, usually <NUM> hours. At this point, normal calculation rules governing the IIR are still in effect, including the intravenous IIR timer (Timer Adjustment process <NUM>), which continues to prompt for blood glucose tests at time intervals TNext as described previously. The SubQ Transition process <NUM> passes to decision block <NUM>, which determines whether the recommended time interval TransitionRunTime has elapsed, e.g., <NUM> hours, after which time SubQ Transition process <NUM> continues to block <NUM>, providing the user with subcutaneous insulin discharge orders and exiting the IV Insulin process in block <NUM>.

<FIG> provides an arrangement of operations for a method <NUM> of administering intravenous insulin to a patient <NUM>. The method <NUM> includes receiving <NUM> blood glucose measurements BG on a computing device (e.g., a processor <NUM> of a patient device <NUM>, a processor <NUM> of a hospital electronic medical record system <NUM>, or a data processor <NUM> of a service provider <NUM>) of a dosing controller <NUM> from a blood glucose measurement device <NUM> (e.g., glucose meter or glucometer). The blood glucose measurements BG are separated by a time interval TNext. The method <NUM> includes determining <NUM>, using the computing device <NUM>, <NUM>, <NUM>, an insulin dose rate IIR based on the blood glucose measurements BG. In some implementations, the method <NUM> determines the insulin dose rate IRR based on a current blood glucose measurement BG, a constant K, and a multiplier M (see EQ. The constant K may equal <NUM>/dl. The method <NUM> includes leaving the multiplier M unchanged between time intervals TNext when the current blood glucose measurement BG is greater than an upper limit BGTRH of the blood glucose target range BGTR and the blood glucose percent drop BG%Drop from the previous blood glucose value BGP is greater than or equal to a desired percent drop BG%dropM (see EQ. The method <NUM> also includes multiplying the multiplier M by a change factor MCF when the current blood glucose measurement BG is greater than an upper limit BGTRH of the blood glucose target range BGTR and the blood glucose percent drop BG%Drop (or blood glucose percent drop) is less than the desired percent drop BG%dropM. Additionally or alternatively, the method <NUM> includes leaving the multiplier M unchanged between time intervals TNext when the current blood glucose measurement BG is in the target range BGTR i.e. when BG is less than an upper limit BGTRH of the blood glucose target range and greater than the lower limit BGTRL of the target range, BGTR. The method <NUM> also includes dividing the multiplier M by a change factor MCF when the current blood glucose measurement BG is less than the lower limit BGTRL of the blood glucose target range BGTR. The method <NUM> may include setting the time interval TNext to a hypoglycemia time interval THypo of between about <NUM> minutes and about <NUM> minutes, when the current blood glucose measurement BG is below a hypo-threshold blood glucose level BGHypo.

The method <NUM> includes determining <NUM> a blood glucose drop rate BGDropRate based on the blood glucose measurements BG and the time interval TNext. The method <NUM> includes determining <NUM> a blood glucose percent drop BG%Drop, using the computing device <NUM>, <NUM>, <NUM> from a previous blood glucose measurement BGP. When the blood glucose drop rate BGDropRate is greater than a threshold drop rate BGDropRateLimit, the method <NUM> includes decreasing at <NUM> the time interval TNext between blood glucose measurements measure by the glucometer.

The method <NUM> also includes decreasing <NUM> the time interval TNext between blood glucose measurements BG when the percent drop BG%Drop of the blood glucose BG is greater than the threshold of the percent drop %DropRegular, where the threshold of the percent drop %DropRegular depends on whether the current blood glucose measurement BG is below a lower limit BGTRL of a blood glucose target range BGTR. In some implementations, the method <NUM> includes decreasing the time interval TNext when the current blood glucose measurement BG is greater than or equal to the lower limit BGTRL of the blood glucose target range BGTR and the blood glucose percent drop BG%Drop exceeds a threshold percent drop %DropRegular. In some implementations, the method <NUM> includes decreasing the time interval TNext when the current blood glucose measurement BG is below the lower limit BGTRL of the blood glucose target range BGTR and above the hypo-threshold blood glucose level BGHypo, and the blood glucose percent drop BG%Drop is greater than or equal to a threshold percent drop %DropLowLimit.

In some examples, the method <NUM> includes leaving the multiplier M unchanged for at least two subsequent time intervals, TNext, when the current blood glucose measurement BG is a pre-meal measurement. In some examples, the method <NUM> includes receiving, on the computing device <NUM>, <NUM>, <NUM>, a number of carbohydrates for a meal as well as a blood glucose measurement, and determining, using the computing device <NUM>, <NUM>, <NUM>, an intravenous insulin rate IIR based on the blood glucose (this IIR may be calculated using EQ. In addition, the method <NUM> includes determining, using the computing device <NUM>, <NUM>, <NUM>, a meal bolus insulin rate IIR based on the number of carbohydrates. The method <NUM> then calculates a Total insulin rate as the sum of the meal bolus rate and the regular intravenous rate as shown in EQ. The method <NUM> may further include setting the time interval TNext to about <NUM> minutes. If the blood glucose measurement BG is a second consecutive measurement after (but not including) an initial pre-meal blood glucose measurement BG, the method <NUM> includes setting the time interval TNext to about <NUM> minutes.

In some implementations, the method <NUM> includes electronically displaying on a display <NUM>, <NUM> a warning and blocking transition to a subcutaneous administration of insulin when the current blood glucose measurement BG is outside a stability target range BGSTR. In addition, the method <NUM> includes electronically displaying on the display <NUM>, <NUM> a warning when the current blood glucose measurement BG is within the patient's personalized target range BGTR for less than a threshold stability period of time TStable. In some examples, the method <NUM> includes determining a total daily dose of insulin TDD based on the multiplier M when the current blood glucose measurement BG is within a stability target range BGSTR for a threshold stability period of time TStable.

These computer programs (also known as programs, software, software applications or code) include machine instructions for a programmable processor and can be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the terms "machine-readable medium" and "computer-readable medium" refer to any computer program product, apparatus and/or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal.

Implementations of the subject matter and the functional operations described in this specification can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Moreover, subject matter described in this specification can be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a computer readable medium for execution by, or to control the operation of, data processing apparatus. The computer readable medium can be a machine-readable storage device, a machine-readable storage substrate, a memory device, a composition of matter affecting a machine-readable propagated signal, or a combination of one or more of them. The terms "data processing apparatus", "computing device" and "computing processor" encompass all apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, or multiple processors or computers. A propagated signal is an artificially generated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal that is generated to encode information for transmission to suitable receiver apparatus.

A computer program (also known as an application, program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment.

Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio player, a Global Positioning System (GPS) receiver, to name just a few.

One or more aspects of the disclosure can be implemented in a computing system that includes a backend component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a frontend component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such backend, middleware, or frontend components.

In some implementations, a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device).

While this specification contains many specifics, these should not be construed as limitations on the scope of the disclosure or of what may be claimed, but rather as descriptions of features specific to particular implementations of the disclosure. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.

In certain circumstances, multi-tasking and parallel processing may be advantageous.

The actions recited in the claims can be performed in a different order and still achieve desirable results.

Claim 1:
A method comprising:
executing, by a data processing device, a program configured to:
receive patient information for a patient;
receive a blood glucose input for a blood glucose measurement of the patient;
obtain a blood glucose time associated with measuring the blood glucose measurement; and
receive a carbohydrate input indicating a number of carbohydrates the patient is about to consume or has begun consuming;
determining, by the data processing device, a multiplier for the patient based on the patient information;
determining, by the data processing device, a regular insulin infusion rate for the patient based on the multiplier for the patient and the blood glucose measurement of the patient;
determining, by the data processing device, an estimated meal bolus for the patient based on the number of carbohydrates the patient is about to consume or has begun consuming and a carbohydrate-to-insulin (CIR) ratio for the patient;
determining, by the data processing device, an estimated meal bolus infusion rate for the patient based on the estimated meal bolus, an available delivery time, and a configurable constant;
determining, by the data processing device, a total insulin infusion rate to administer to the patient based on the regular infusion rate for the patient and the estimated meal bolus infusion rate for the patient;
and
transmitting the total insulin infusion rate from the data processing device to a patient display and displaying a number of units of insulin corresponding to a value of the total insulin infusion rate on the patient display.