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EP-3046600-B1 - INSULIN MANAGEMENT

EP3046600B1EP 3046600 B1EP3046600 B1EP 3046600B1EP-3046600-B1

Inventors

  • BOOTH, ROBERT, C.
  • HEBBLEWHITE, HARRY

Dates

Publication Date
20260506
Application Date
20150115

Claims (9)

  1. A system (100) comprising: a glucometer (124) configured to measure blood glucose measurements (BG) separated by a time interval (T Next ); and a dosing controller (160) in communication with the glucometer (124), the dosing controller (160) including a data processing device (112) and non-transitory memory (24, 114, 144) in communication with the data processing device (112), the dosing controller (160) configured to perform operations comprising: receiving blood glucose measurements (BG) of a patient (10) from the glucometer (124), each blood glucose measurement (BG) separated by a time interval (T Next ) and comprising a blood glucose time (BG Time ) associated with a time of measuring the blood glucose measurement (BG); executing a subcutaneous insulin treatment program determining recommended insulin doses based on the blood glucose times (BG Time ), the subcutaneous insulin treatment program comprising: determining if the blood glucose time (BG Time ) is within a pre-configured time interval ((Tschedi - MStart) to (Tschedi+ MEnd)); setting a timer (430) for a next blood glucose measurement (BG next ) based on the pre-configured time interval ((Tschedi - MStart) to (Tschedi+ MEnd)); and determining a correction insulin (CB) dose based on the blood glucose time (BG Time ) by calculating: CB = BG − BG Target / CF ; wherein CB is the correction insulin dose, BG is the blood glucose measurement, BG Target is a target blood glucose value of the patient (10), and CF is a correction factor; further comprising, when the blood glucose time (BG Time ) is within a first one of four-preconfigured time intervals ((Tsched1 - MStart) to (Tsched1+ MEnd)) each spaced six hours apart from the next or within a second one of six pre-configured time intervals ((T sched 2 - M Start ) to (T sched 2+ M End )) each spaced four hours apart from the next: setting the blood glucose measurement (BG) as a governing blood glucose value (BG gov ); determining an adjustment factor (AF) by determining the governing blood glucose value (BG gov ) is within one of multiple pre-configured ranges of values, and setting the adjustment factor (AF) to a pre-configured adjustment factor (AF) associated with the pre-configured range of values that includes the governing blood glucose value (BG gov ); retrieving a previous day's value of recommended equal-boluses (EqBolus); and determining a new value of recommended equal-boluses (EqBolus) by multiplying the adjustment factor (AF) times the previous day's value of recommended equal-boluses (EqBolus), the new value of recommended equal-boluses (EqBolus) corresponding to an insulin dose of rapid-acting insulin or regular insulin to be administered to the patient (10) at scheduled blood glucose measurements (BG); transmitting the insulin doses determined by the subcutaneous insulin treatment program to an administration device (123, 123a, 123b) in communication with the dosing controller (160), the administration device (123, 123a, 123b) comprising: a doser (223a, 223b); and an administration computing device (112a, 112b) in communication with the doser (223a, 223b), the administration computing device (112a, 112b), when executing the subcutaneous insulin treatment program, causing the doser (223a, 223b) to administer the recommended insulin doses determined by the subcutaneous insulin treatment program..
  2. The system (100) of claim 1, wherein the dosing controller (160) is further configured to perform operations comprising determining a pre-meal correction bolus (CB) by calculating: CB = BG − BG Target / CF wherein CB is the pre-meal correction bolus, BG is the blood glucose measurement, BG Target is a target blood glucose of the patient (10), and CF is a correction factor.
  3. The system (100) of claim 1, wherein the dosing controller (160) is further configured to perform operations comprising determining a post-prandial correction bolus (CB Post ) by calculating: CB post = BG − BG Target CF − Previous Bolus e − T Current − T Previous iLifeRapid wherein CB Post is a post meal correction dose, T Current is a current time, and T PrevBolus is a previous time at which a last bolus was given to the patient (10), iLifeRapid is a mean lifetime for a rapid-acting insulin.
  4. The system (100) of claim 3, wherein the dosing controller (160) is further configured to perform operations comprising: receiving a half-life value of the rapid-acting insulin; and determining the mean lifetime (iLifeRapid) of the rapid-acting insulin by calculating: iLifeRapid = Half − life * In 2 wherein Half-life is a half-life value of the rapid-acting insulin.
  5. The system (100) of claim 1, wherein the dosing controller (160) is further configured to perform operations comprising determining a Carbohydrate-to-Insulin Ratio (CIR) based on the adjustment factor (AF) by calculating: CIR = CIR Previous / AF ; wherein CIR is the Carbohydrate-to-Insulin Ratio, CIR Previous is a previously determined Carbohydrate-to-Insulin Ratio, and AF is the adjustment factor.
  6. The system (100) of claim 24, wherein the dosing controller (160) is further configured to perform operations comprising, when the blood glucose time (BG Time ) is within a second one of six-preconfigured time intervals ((Tsched2 - MStart) to (Tsched2+ MEnd)) each spaced four hours apart from the next: setting the blood glucose measurement (BG) as a governing blood glucose value (BG gov ); determining a basal dose adjustment factor (AF) for adjusting a current day's recommended basal dose (RecBasal) based on the governing blood glucose value (BG gov ); retrieving a previous day's recommended basal dose (RecBasal); and determining the current day's recommended basal dose (RecBasal) by multiplying the basal dose adjustment factor (AF) times the previous day's recommended basal dose (RecBasal), the current day's recommended basal dose (RecBasal) corresponding to an insulin dose of long-acting insulin to be administered to the patient (10) at a configurable frequency of one, two, or three times per day.
  7. The system (100) of claim 24, wherein the dosing controller (160) is further configured to perform operations comprising, when the blood glucose time (BG Time ) is within a second one of six-preconfigured time intervals ((Tsched2 - MStart) to (Tsched2+ MEnd)) each spaced four hours apart from the next: setting the blood glucose measurement (BG) as a governing blood glucose value (BG gov ); determining a basal dose adjustment factor (AF) for adjusting a current day's recommended basal dose (RecBasal) based on the governing blood glucose value (BG gov ); retrieving a previous day's recommended basal dose (RecBasal); and determining the current day's recommended basal dose (RecBasal) by multiplying the basal dose adjustment factor (AF) times the previous day's recommended basal dose (RecBasal), the current day's recommended basal dose (RecBasal) corresponding to an insulin dose of long-acting insulin to be administered to the patient (10) at a configurable frequency of one, two, or three times per day.
  8. The system (100) of claim 1, wherein the multiple pre-configured ranges of values comprise: a first range of values including blood glucose values less than a first configurable constant; a second range of values including blood glucose values greater than or equal to the first configurable constant and less than a low target blood glucose value of a target blood glucose range for the patient; a third range of values including blood glucose values greater than or equal to the low target blood glucose value and less than a high target blood glucose value of the target blood glucose range; a fourth range of values including blood glucose values greater than or equal to the high target blood glucose value and less than a second configurable constant; a fifth range of values including blood glucose values greater than or equal to the second configurable constant and less than a third configurable constant; and a sixth range of values including blood glucose values greater than or equal to the third configurable constant.
  9. The system (100) of claim 1, wherein the subcutaneous insulin treatment program is a subcutaneous insulin treatment program for tube-fed patients (1000) and wherein the dosing controller (160) is further configured to perform operations comprising: receiving patient information (208a); selecting the subcutaneous insulin treatment program for tube-fed patients (1000) from a collection of subcutaneous insulin treatments (900, 1000, 1100, 1200, 1300, 1400) based on the blood glucose measurements (BG) and the patient information (208a).

Description

TECHNICAL FIELD This disclosure relates to a system for managing insulin administration or insulin dosing. BACKGROUND Today, nearly 40% 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. US 6 656 114 B1 discloses a method of assisting a patient in self-treating diabetes including collecting diabetes data. The data is processed to provide a plurality of alternate choices between two or more actions that may be taken, and a corresponding value for each action is calculated. US 2007/078314 A1 is directed to a system and method for measuring and predicting optimal insulin dosing rates in order to bring a patient's blood glucose level into a preferred target range. US 2013/165901 A1 discloses a method for determining an insulin-based therapy. Adjusting a current insulin recommendation is based on the use of glomerular filtration rate (GFR) adjusted insulin effect curves to provide an appropriate action when the patient suffers from renal insufficiency. SUMMARY OF THE INVENTION The invention is defined in the appended claims. SUMMARY OF RELATED DISCLOSURE One aspect of the disclosure provides a method of administering insulin. The method includes receiving blood glucose measurements of a patient at a data processing device from a glucometer. The blood glucose measurements are separated by a time interval and include a blood glucose time associated with a time of measuring the blood glucose measurement. The method also includes receiving patient information at the data processing device. The method includes selecting, using the data processing device, a subcutaneous insulin treatment program for tube-fed patients from a collection of subcutaneous insulin treatments. The selection is based on the blood glucose measurements and the patient information. The subcutaneous insulin treatment program for tube-fed patients determines the recommended insulin doses based on the blood glucose times. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment for tube-fed patients. Implementations of the disclosure may include one or more of the following optional features. In some implementations, the method includes: receiving, at the data processing device, a configurable constant; storing the configurable constant in non-transitory memory associated with the data processing device; and determining a correction factor using the data processing device. The configurable constant may be determined from a published statistical correlation. The method may also include determining a pre-meal correction bolus, using the data processing device. The method may include determining, using the data processing device, a post-prandial correction bolus. The method may also include receiving, at the data processing device, a half-life value of the rapid-acting insulin; and determining, using the data processing device, the mean lifetime of the rapid-acting insulin. In some implementations, the method includes receiving, at the data processing device, a governing blood glucose value, and determining, using the data processing device, an adjustment factor based on the received governing blood glucose value. Determining the adjustment factor may include determining when the governing blood glucose value is within a pre-configured range of values, and setting the adjustment factor to a preconfigured adjustment factor associated with the pre-configured range of values. Determining the adjustment factor may further include determining the governing blood glucose value is within one of multiple pre-configured ranges of valu