Systems, devices and related methods of insulin management for delivering insulin during a fasting period

Abstract

According to some embodiments, an insulin management method implemented by an insulin delivery system is provided. The method includes determining an assumed insulin on board based on an assumed external dose calculated to correct an initial blood glucose value of the user to a target blood glucose. The method includes delivering insulin from an insulin delivery device with the insulin in the form of a plurality of correction bolus doses during a fasting period in response to received blood glucose measurements, the correction bolus doses compensated for by a determined insulin on board, wherein for at least a first correction bolus dose of the plurality of correction bolus doses the determined insulin on board equals the assumed insulin on board. Other systems, devices and methods are also provided.

1 . An insulin management method implemented by an insulin delivery system, comprising:
 determining an assumed insulin on board based on an assumed external dose calculated to correct an initial blood glucose value of the user to a target blood glucose; and   delivering insulin from an insulin delivery device with the insulin in the form of a plurality of correction bolus doses during a fasting period in response to received blood glucose measurements, the correction bolus doses compensated for by a determined insulin on board, wherein for at least a first correction bolus dose of the plurality of correction bolus doses the determined insulin on board equals the assumed insulin on board.   
     
     
         2 . The method of  claim 1 , wherein the insulin delivery device is an automatic insulin delivery device attachable to a user's body for a duration of the fasting period and configured to refrain from administering basal insulin at a preset or default rate or in a preset or default pattern. 
     
     
         3 . The method of  claim 1 , further comprising:
 calculating each of the plurality of correction bolus doses by comparing an evaluated blood glucose measurement to the target blood glucose to obtain a difference, adjusting the difference by a user insulin sensitivity factor to obtain a resultant dose amount, and reducing the resultant dose amount by the determined insulin on board.   
     
     
         4 . The method of  claim 1 , further comprising, at the start of the delivery from the insulin delivery device, calculating the assumed external dose to correct an initial blood glucose measurement of the user to the target blood glucose. 
     
     
         5 . The method of  claim 1 , wherein the determined insulin on board is a combination of at least the assumed insulin on board and a known delivered insulin from the delivery device during the fasting period once insulin is delivered. 
     
     
         6 . The method of  claim 3 , wherein the correction bolus doses are calculated based on a user's insulin sensitivity factor obtained for the user. 
     
     
         7 . The method of  claim 6 , wherein the user's insulin sensitivity factor is derived from a total daily basal dose information used in a defined period prior to the fasting period. 
     
     
         8 . The method of  claim 3 , wherein the correction bolus doses are calculated based on at least one of a fixed target blood glucose for all users and a fixed insulin action time for all users. 
     
     
         9 . The method of  claim 3 , wherein the evaluated blood glucose measurement is evaluated at least in part by smoothing the received blood glucose measurements with a low pass filter to reduce the effect of noise and/or abrupt perturbations to obtain blood glucose values. 
     
     
         10 . The method of  claim 3 , wherein the evaluated blood glucose measurement is evaluated at least in part by retaining a received blood glucose measurement that is less than a rolling average of a predetermined number of prior received blood glucose measurements and retaining the rolling average for the received blood glucose measurement otherwise. 
     
     
         11 . The method of  claim 3 , wherein the evaluated blood glucose measurement is evaluated at least in part by projecting a downward trend of the received blood glucose measurements forward and adding the downward trend to the blood glucose measurement value used in the dose calculation. 
     
     
         12 . The method of  claim 11 , wherein the downward trend is determined based at least in part on a largest negative slope between any received blood glucose measurement within a predetermined timeframe and a reference blood glucose measurement. 
     
     
         13 . The method of  claim 3 , wherein the evaluated blood glucose measurement is evaluated at least in part by fitting received blood glucose measurements within a predetermined timeframe to a trend having a median slope selected from a plurality of regression fit slopes for different rolling subsets of received blood glucose measurements within the predetermined timeframe. 
     
     
         14 . The method of  claim 3 , wherein the evaluated blood glucose measurement is evaluated at least in part by filtering the received blood glucose measurements, the filtering comprising:
 imposing a progressively increasing limit on how much each next received blood glucose measurement can increase compared to the previous received blood glucose measurement for increasing received blood glucose measurements; and   amplifying how much each next received blood glucose measurement decreases compared to the previous received blood glucose measurement for decreasing received blood glucose measurements.   
     
     
         15 . The method of  claim 1 , comprising limiting the correction bolus doses to a defined maximum dose per correction bolus dose such that the correction bolus dose is a divided portion of a total correction bolus dose. 
     
     
         16 . An insulin management method implemented by a controller of an insulin delivery device for delivering insulin during a fasting period from a delivery device in the form of a wearable automated insulin delivery device, comprising:
 determining a user insulin sensitivity factor;   receiving blood glucose measurements;   evaluating the blood glucose measurements to obtain evaluated blood glucose values;   determining an assumed insulin on board based on an assumed external dose calculated to correct an initial blood glucose value of the user to a target blood glucose;   calculating periodic correction bolus doses by comparing an evaluated blood glucose value to a target blood glucose to obtain a difference, the difference adjusted by the user insulin sensitivity factor to obtain a resultant dose amount, and the resultant dose amount compensated by a determined insulin on board, wherein:
 correction bolus doses in an initial period are calculated using the determined insulin on board set equal to the assumed insulin on board; and 
 delivering at least a portion of a calculated correction dose at periodic time intervals. 
   
     
     
         17 . The method of  claim 16 , wherein the assumed insulin on board is initially assumed to be sufficient to bring an initial blood glucose measurement into a target range and is reduced over time during the fasting period. 
     
     
         18 . The method of  claim 17 , including adjusting the assumed insulin on board over time based on comparisons between to the evaluated blood glucose measurement. 
     
     
         19 . The method of  claim 16 , wherein the determined insulin on board includes a known delivered insulin from delivered correction doses from the delivery device during the fasting period. 
     
     
         20 . The method of  claim 16 , including dividing the correction dose into delivery portions with a maximum delivery rate for a maximum amount of insulin to be delivered over a given time period. 
     
     
         21 . The method of  claim 16 , including determining an initial user insulin sensitivity factor for the fasting period based on a received total daily basal dose information. 
     
     
         22 . The method of  claim 21 , including adjusting the initial user insulin sensitivity factor by a sensitivity safety factor configured to bias the calculating periodic correction bolus doses to less insulin dosage. 
     
     
         23 . The method of  claim 16 , including adjusting the target blood glucose by a target safety factor based at least in part on a difference between a received blood glucose measurement and the target blood glucose. 
     
     
         24 . The method of  claim 16 , including adjusting the calculated correction bolus dose by an overall safety factor configured to limit the calculated bolus dose to a a maximum delivery rate for insulin to be delivered over a time period between delivery of correction bolus doses. 
     
     
         25 . The method of  claim 16 , wherein the target blood glucose is time varying to decrease over time during the fasting period and a rate of decrease over time of the target blood glucose is determined based on an assumption that blood glucose levels are being lowered by existing externally administered insulin administered prior to the fasting period. 
     
     
         26 . The method of  claim 16 , wherein the user insulin sensitivity factor is initially set at a predetermined value and adjusted over time based at least in part on a difference between received blood glucose measurements and expected blood glucose. 
     
     
         27 . The method of  claim 16 , wherein evaluating the blood glucose measurements includes filtering for increasing blood glucose values and not filtering for decreasing blood glucose values. 
     
     
         28 . The method of  claim 16 , wherein evaluating the blood glucose measurements includes adjusting for a long term downward trend over a period of hours in the fasting period. 
     
     
         29 . The method of  claim 16 , wherein delivering at least a portion of the correction doses includes delivering a first zero dose. 
     
     
         30 . An insulin management system of an insulin delivery device in the form of an automatic insulin delivery device attachable to a user's body for a duration of a fasting period, the system comprising:
 a delivery component of the insulin delivery device configured to deliver insulin in the form of a plurality of correction bolus doses in response to received blood glucose measurements, the correction bolus doses compensated for by a determined insulin on board, wherein for at least a first correction bolus dose of the plurality of correction bolus doses the determined insulin on board equals an assumed insulin on board based on an assumed external dose calculated to correct an initial blood glucose value of the user to a target blood glucose.   
     
     
         31 . The system of  claim 30 , wherein the delivery component includes:
 an insulin sensitivity factor receiving component configured to determine a user insulin sensitivity factor;   a blood glucose measurement receiving component configured to periodically receive blood glucose measurements;   a blood glucose measurement evaluating component configured to evaluate the blood glucose measurements;   a correction dose calculating component configured to calculate the periodic correction bolus; and   the delivery component delivering at least a portion of a calculated correction dose at time intervals.   
     
     
         32 . The system of  claim 31 , wherein the insulin sensitivity factor receiving component is configured to derive an initial insulin sensitivity factor from a total daily basal dose information received from a non-fasting insulin management modality in a defined period prior to the fasting period for use in determining the correction bolus doses. 
     
     
         33 . The system of  claim 30 , wherein the delivery component includes an insulin on board determining component including an assumed insulin on board component for configured to calculate an initial assumed correction dose to correct an initial blood glucose measurement of the user to a target blood glucose. 
     
     
         34 . The system of  claim 33 , wherein the insulin on board determining component also includes a device insulin on board component and the correction bolus doses of the fasting period are calculated based on assumed insulin on board and known delivered insulin from the delivery device. 
     
     
         35 . The system of  claim 30 , wherein the delivery component includes an activation component for detecting activation of the delivery device to commence delivery of insulin from the fasting insulin delivery device. 
     
     
         36 . The system of  claim 31 , wherein the correction dose calculating component is configured to determine the correction bolus doses for the fasting period at each blood glucose measurement timepoint to determine if insulin is required to bring the user to a target blood glucose. 
     
     
         37 . The system of  claim 31 , wherein the measurement evaluating component is configured to perform at least one of:
 smoothing the received blood glucose measurements with a low pass filter to reduce the effect of noise and/or abrupt perturbations to obtain blood glucose values;   retaining a received blood glucose measurement that is less than a rolling average of a predetermined number of prior received blood glucose measurements and retaining the rolling average for the received blood glucose measurement if the received blood glucose is not less than the rolling average;   projecting a downward trend of the received blood glucose measurements forward and adding the downward trend to the blood glucose measurement value used in the dose calculation;   filtering the received blood glucose measurements, the filtering comprising imposing a progressively increasing limit on how much each next received blood glucose measurement can increase compared to the previous received blood glucose measurement for increasing received blood glucose measurements, and amplifying how much each next received blood glucose measurement decreases compared to the previous received blood glucose measurement for decreasing received blood glucose measurements; and
 fitting received blood glucose measurements within a predetermined timeframe to a trend having a median slope selected from a plurality of regression fit slopes for different rolling subsets of received blood glucose measurements within the predetermined timeframe. 
   
     
     
         38 . The system of  claim 30 , wherein the delivery component includes a correction dose limiting component configured to limit the correction bolus doses for the fasting period to a defined maximum dose given at any time point to minimize sudden corrections. 
     
     
         39 . The system of  claim 38 , wherein the correction dose limiting component is configured to limit each of the correction bolus doses for the fasting period to at least a minimum dose deliverable by the delivery device hardware. 
     
     
         40 . The system of  claim 30 , wherein the delivery component includes a safety factor component configured to provide safety factors to parameters on which the dose correction is based. 
     
     
         41 . The system of  claim 30 , wherein the delivery component includes including an end-procedure component configured to coordinate an end bolus delivery at the end of the fasting period. 
     
     
         42 . The system of  claim 30 , wherein the delivery component includes a processor and a memory configured to provide non-transitory, computer-readable program instructions to the processor to execute functions of the components. 
     
     
         43 . The system of  claim 30 , including a mobile user computing device comprising:
 a processor and a memory configured to provide non-transitory, computer-readable program instructions to the processor to execute functions of components:   a basal insulin input component for requesting a value from a user of a total daily basal dose information used in a defined period prior to the fasting period; and   a controller pairing component for pairing the mobile user computing device to a controller of the delivery device.   
     
     
         44 . An automatic insulin delivery device attachable to a user's body for a duration of a fasting period, the device comprising:
 a durable portion including a delivery component configured to control a delivery of insulin in the form of a plurality of correction bolus doses in response to received blood glucose measurements, at least the first correction bolus dose of the plurality of correction bolus doses determined based on a determined insulin on board equal to an assumed insulin on board that is determined based on an assumed external dose calculated to correct an initial blood glucose value of the user to a target blood glucose; and   a disposable portion including a reservoir configured to contain insulin and configured to automatically deliver the correction bolus doses to the user.   
     
     
         45 . The device of  claim 44 , wherein the reservoir is configured to be fillable from a non-fasting insulin injection device used during a non-fasting period. 
     
     
         46 . A computer-implemented method for managing delivery of insulin during a fasting period from a delivery device in the form of a wearable automated insulin delivery device worn for the fasting period, wherein the method is carried out by a computing application provided at a mobile user computing device, the method comprising:
 requesting a value from a user of a total daily basal dose information used in a defined period prior to the fasting period;   pairing the mobile user computing device to a controller of the delivery device, the controller configured to control a delivery of insulin in the form of a plurality of correction bolus doses in response to received blood glucose measurements, the correction bolus doses compensated for by a determined insulin on board, wherein for at least a first correction bolus dose of the plurality of bolus doses the determined insulin on board is equal to an assumed insulin on board based on an assumed external dose calculated to correct an initial blood glucose value of the user to a target blood glucose; and   transmitting and receiving information to and from the controller of the delivery device during the fasting period.   
     
     
         47 . The method of  claim 46 , wherein requesting a value from a user of a total daily basal dose information includes requesting a usual number of units of basal insulin received from a non-fasting form of insulin therapy. 
     
     
         48 . The method of  claim 46 , wherein the method includes pairing the mobile user computing device to a blood glucose monitor to transfer blood glucose measurements to the delivery device. 
     
     
         49 . The method of  claim 46 , wherein the method provides a display of a session history of information relating to the fasting period. 
     
     
         50 . The method of  claim 46 , wherein the method includes providing user training in use of a delivery device. 
     
     
         51 . The method of  claim 46 , wherein the method includes coordinating a fast-ending procedure for the user including dividing a fast-ending meal bolus into a first portion equal to a remaining insulin in the delivery device at the end of the fasting period and a second portion to be delivered to the user utilizing a delivery method other than the delivery device in a non-fasting period immediately following the fasting period.