Basal rate testing using frequent blood glucose input

Abstract

An apparatus comprising a user interface configured to generate an electrical signal to start a basal insulin rate test when prompted by a user, an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration during delivery of insulin according to a specified basal insulin rate pattern, and a controller communicatively coupled to the input and the user interface. The controller includes an insulin calculation module configured for determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline. Other devices and methods are disclosed.

1 . An apparatus comprising:
 a user interface configured to generate an electrical signal to start a basal insulin rate test when prompted by a user;   an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration when insulin is delivered according to a specified basal insulin rate pattern; and   a controller communicatively coupled to the input and the user interface, the controller including an insulin calculation module, wherein the insulin calculation module is configured to determine at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline.   
     
     
         2 . The apparatus of  claim 1 , wherein the insulin calculation module is configured to determine the over-delivered amount and the under-delivered amount using a correction factor of the patient and a variance of a blood glucose level from the target blood glucose baseline. 
     
     
         3 . The apparatus of  claim 2 , wherein the insulin calculation module is configured to determine the over-delivered amount and the under-delivered amount using an adjusted correction factor of the patient. 
     
     
         4 . The apparatus of  claim 2 , wherein the insulin calculation module is configured to determine a recommended change, if any, to the basal insulin rate pattern. 
     
     
         5 . The apparatus of  claim 4 , wherein the recommended change precedes any actual time of over-delivery or under-delivery by a time duration that compensates for a lag time associated with subcutaneous insulin delivery. 
     
     
         6 . The apparatus of  claim 4 , wherein the user interface includes a display operatively coupled to the controller, and wherein the controller is configured to display at least one user instruction for the basal insulin rate test. 
     
     
         7 . The apparatus of  claim 6 , wherein the controller is configured to display a recommended change to a basal insulin rate pattern. 
     
     
         8 . The apparatus of  claim 4 , including:
 a pump mechanism configured to deliver insulin according to the specified basal insulin rate pattern; and   a memory to store at least one basal insulin rate pattern, wherein the pump mechanism and the memory are operatively coupled to the controller.   
     
     
         9 . The apparatus of  claim 8 , including a blood glucose monitor communicatively coupled to the input. 
     
     
         10 . The apparatus of  claim 9 , wherein the blood glucose monitor is a continuous blood glucose monitor configured to automatically collect the sampled blood glucose data. 
     
     
         11 . The apparatus of  claim 10 , including:
 a display operatively coupled to the controller, and   wherein the controller is configured to prompt the user, via the display, to begin a blood glucose measurement using the blood glucose monitor.   
     
     
         12 . The apparatus of  claim 8 , wherein the user interface and the input are configured to receive the sampled blood glucose data entered manually by the user. 
     
     
         13 . The apparatus of  claim 12 , including:
 a display operatively coupled to the controller, wherein the controller is configured to display user instructions for the basal rate test, including periodically prompting the user to enter a blood glucose value.   
     
     
         14 . The apparatus of  claim 8 , wherein the insulin calculation module is configured to determine an amount of active insulin in the patient and to cancel the basal insulin rate test if the active insulin amount is above a specified threshold insulin amount. 
     
     
         15 . The apparatus of  claim 8 , wherein the controller is configured to determine whether an insulin bolus dose is delivered and to cancel the basal insulin rate test if it determines that an insulin bolus dose is delivered during the basal insulin rate test. 
     
     
         16 . The apparatus of  claim 8 , including a real time clock coupled to the controller, wherein the controller is configured to vary a basal rate of insulin delivery by a time of day according to the basal rate pattern. 
     
     
         17 . The apparatus of  claim 4 , wherein the input is a first input and the apparatus further includes:
 a blood glucose sensor circuit operatively coupled to the first input, the blood glucose sensor circuit configured to produce a blood glucose signal representative of a blood glucose level of the patient and provide the sampled blood glucose data to the first input;   a second input communicatively coupled to the controller, wherein the second input is configured to receive information related to insulin delivery according to the basal rate pattern, and   wherein the insulin calculation module is configured to determine at least one of the amount of basal insulin over-delivered and the amount of basal insulin under-delivered using the insulin delivery information and the sampled blood glucose data.   
     
     
         18 . The apparatus of  claim 17 , including a communication port communicatively coupled to the second input, the communication port to receive the information related to insulin delivery. 
     
     
         19 . The apparatus of  claim 18 , wherein the controller is configured to communicate a recommended change to the basal rate pattern through the communication port. 
     
     
         20 . The apparatus of  claim 17 , wherein the user interface and the second input are configured to receive the information related to insulin delivery that is entered manually by the user. 
     
     
         21 . The apparatus of  claim 4 , wherein the input includes a communication port configured to receive the sampled blood glucose data together with at least one time-stamp and to receive time-stamped information related to insulin delivered according to the basal rate pattern, and
 wherein the insulin calculation module is configured to determine at least one of the amount of basal insulin over-delivered or under-delivered using the time-stamped sampled blood glucose data and the time-stamped information related to delivered insulin.   
     
     
         22 . The apparatus of  claim 21 , wherein the controller is configured to communicate a recommended change to the basal rate pattern through the communication port. 
     
     
         23 . The apparatus of  claim 1 , wherein the insulin calculation module is configured to calculate a lag time associated with subcutaneous insulin delivery using at least one of:
 a type of insulin;   an activity level of the patient;   a fitness level of the patient; and   the method used to obtain the blood glucose data.   
     
     
         24 . The apparatus of  claim 1 , wherein the insulin calculation module is configured to calculate a lag time associated with subcutaneous insulin delivery using blood glucose data obtained during at least one of a period prior to the basal rate test and a period during the basal rate test. 
     
     
         25 . The apparatus of  claim 1 , wherein the controller is configured to cancel the basal insulin rate test if a blood glucose level of the patient is outside of a specified range of blood glucose level. 
     
     
         26 . The apparatus of  claim 1 , including:
 a timer circuit; and   a display, wherein the timer circuit and the display are operatively coupled to the controller, and wherein the controller is configured to display user instructions for the basal insulin rate test at one or more specified times during a day.   
     
     
         27 . The apparatus of  claim 26 , wherein the controller is configured to display user instructions for executing the basal insulin rate test during a substantially same time on multiple days. 
     
     
         28 . The apparatus of  claim 26 , wherein the insulin calculation module is configured to:
 determine a time-varying basal insulin rate function using the blood glucose data; and   determine a recommended change, if any, to the basal insulin rate pattern using the time-varying basal insulin rate function.   
     
     
         29 . The apparatus of  claim 28 , wherein the insulin calculation module is configured to:
 determine a time-varying overnight basal insulin rate function using the blood glucose data; and   determine a recommended change to an overnight basal insulin rate pattern using the time-varying overnight basal insulin rate function.   
     
     
         30 . A method comprising:
 receiving a user prompt in a blood glucose (BG) management device to start a basal insulin rate test;   receiving sampled blood glucose data into the BG management device, wherein the sampled blood glucose data is obtained during a specified time duration, including a time duration when insulin is delivered according to a specified basal insulin rate pattern; and   determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered in trying to meet a target blood glucose baseline during the basal insulin rate test.   
     
     
         31 . The method of  claim 30 , including automatically recommending a change, if any, to the basal insulin rate pattern using the BG management device. 
     
     
         32 . The method of  claim 31 , wherein the recommended change to the basal insulin rate pattern precedes any actual time of over-delivery or under-delivery by a time duration that compensates for a lag time associated with subcutaneous insulin delivery. 
     
     
         33 . The method of  claim 32 , including calculating the lag time using at least one of:
 a type of insulin;   an activity level of the patient;   a fitness level of the patient; and   whether the blood glucose data was obtained from blood or from interstitial fluid.   
     
     
         34 . The method of  claim 32 , including calculating the lag time using blood glucose data obtained during at least one of a period prior to the basal rate test and a period during the basal rate test. 
     
     
         35 . The method of  claim 31 , including displaying at least one instruction for the basal insulin rate test using the BG management device. 
     
     
         36 . The method of  claim 31 , wherein determining an amount over-delivered and an under-delivered includes determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered using an adjusted correction factor of the patient and a variance of a blood glucose level from the target blood glucose baseline. 
     
     
         37 . The method of  claim 31 , including delivering insulin according to the specified basal insulin rate pattern using the BG management device. 
     
     
         38 . The method of  claim 37 , including:
 determining an amount of active insulin in the patient prior to delivering basal insulin according to the basal rate test; and   canceling the basal insulin rate test if an amount of active insulin is above a specified threshold active insulin amount.   
     
     
         39 . The method of  claim 37 , including canceling the basal insulin rate test if an insulin bolus dose is delivered during the basal insulin rate test. 
     
     
         40 . The method of  claim 37 , wherein receiving sampled blood glucose data includes automatically receiving the sampled blood glucose data from a blood glucose monitor included in the BG management device. 
     
     
         41 . The method of  claim 37 , wherein receiving sampled blood glucose data includes:
 obtaining the sampled blood glucose data using a device separate from the BG management device; and   receiving the sampled blood glucose data into the BG management device from the separate device through a communication port.   
     
     
         42 . The method of  claim 41 , wherein receiving sampled blood glucose data includes wirelessly receiving the sampled blood glucose data into the BG management device from the separate device through a wireless communication port. 
     
     
         43 . The method of  claim 41 , wherein receiving sampled blood glucose data includes periodically prompting a user through a user interface of the BG management device to obtain blood glucose data using the separate device. 
     
     
         44 . The method of  claim 41 , wherein receiving sampled blood glucose data includes receiving the sampled blood glucose data through a user interface of the BG management device configured for manual entry of blood glucose data. 
     
     
         45 . The method of  claim 41 , wherein receiving sampled blood glucose data includes prompting a user to manually enter a blood glucose value during the basal insulin rate test. 
     
     
         46 . The method of  claim 31 , including:
 delivering insulin according to the specified basal insulin rate pattern using a second device;   wherein receiving sampled blood glucose data includes automatically receiving the sampled blood glucose data from a blood glucose monitor included in the BG management device; and   wherein the method includes receiving information related to insulin delivery, including an amount of insulin delivered according to the basal rate pattern, into the BG management device.   
     
     
         47 . The method of  claim 46 , wherein receiving the information related to insulin delivery includes receiving the information related to insulin delivery from the second device through a communication port. 
     
     
         48 . The method of  claim 47 , including communicating a recommended change to the basal insulin rate pattern to the second device using the communication port. 
     
     
         49 . The method of  claim 46 , wherein receiving the information related to insulin delivery includes receiving the information related to insulin delivery manually through a user interface on the BG management device. 
     
     
         50 . The method of  claim 46 , including displaying a recommended change to the basal insulin rate pattern using the BG management device. 
     
     
         51 . The method of  claim 31 , including:
 delivering insulin according to the specified basal insulin rate pattern using a second device;   receiving information related to insulin delivery, including the amount of insulin delivered according to the basal rate pattern, into the BG management device,   wherein receiving sampled blood glucose data includes receiving time-stamped sampled blood glucose data into the BG management device; and   determining the at least one of the amount of basal insulin over-delivered and the amount of basal insulin under-delivered using the time-stamped sampled blood glucose data and the information related to insulin delivery.   
     
     
         52 . The method of  claim 31 , including:
 determining a time varying correction factor function using the sampled blood glucose data and the specified basal rate pattern; and   determining a time varying basal rate pattern to achieve the target blood glucose baseline using the correction factor function.   
     
     
         53 . The method of  claim 52 , including recommending a change to the specified basal rate pattern using the determined time varying basal rate pattern. 
     
     
         54 . An apparatus comprising:
 means for receiving a user prompt in a blood glucose (BG) management device to start a basal insulin rate test;   means for receiving sampled blood glucose data of a patient into a blood glucose (BG) management device, wherein the sampled blood glucose data is obtained during a specified time duration, including a time duration during delivery of insulin according to a specified basal insulin rate pattern; and   means for determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered in trying to meet a target blood glucose baseline during the basal insulin rate test using the BG management device.