Systems, Devices, and Methods for Alleviating Glucotoxicity and Restoring Pancreatic Beta-Cell Function in Advanced Diabetes Mellitus

Abstract

Systems, methods and/or devices for treating diabetes mellitus by alleviating glucotoxicity and restoring pancreatic beta-cell function, comprising at least a first memory for storing data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen, and data inputs corresponding at least to the patient's blood-glucose-level measurements determined at a plurality of times, and a processor operatively connected to the at least first memory. The processor is programmed at least to determine from the data inputs corresponding to the patient's blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the components of the patient's present insulin dosage regimen. Also disclosed are systems, methods, and/or devices for alleviating glucotoxicity and restoring pancreatic beta-cell function, comprising establishing the patient's current glycemic state relative to a desired glycemic range and determining from at least one of a plurality of the data corresponding to the patient's blood glucose-level measurements whether and by how much to adjust at least one of the components in the patient's present insulin dosage regimen.

1 . A method for treating diabetes mellitus by alleviating glucotoxicity and/or restoring pancreatic beta-cell function in a patient, the method comprising:
 storing one or more components of the patient's insulin dosage regimen;   drawing blood samples from the patient at a plurality of times;   ascertaining the patient's blood glucose-level measurements in said blood samples;   tagging each of said blood glucose-level measurements with an identifier reflective of when said measurement was obtained;   establishing the patient's current glycemic state relative to a desired glycemic range;   determining from the patient's blood glucose-level measurements whether and by how much to adjust at least one component of the one or more components of the patient's present insulin dosage regimen to stay within said desired glycemic range and administer the lowest insulin dosage;   adjusting said at least one component in accordance with said determination; and   performing said steps of the method until the insulin dosage regimen required to stay within the desired glycemic range is lowered to a predetermined level.   
     
     
         2 . The method of  claim 1 , wherein the adjustment to the patient's insulin dosage regimen is performed in substantially real time. 
     
     
         3 . The method of  claim 1  wherein an initial insulin dosage regimen is provided by a physician or other healthcare professional 
     
     
         4 . The method of  claim 1 , wherein the method is performed without any intervention from a doctor or other healthcare professional. 
     
     
         5 . The method of  claim 1  wherein the desired glycemic range changes over time and the adjustment to patient's insulin dosage regimen is to get within the most recent desired glycemic range. 
     
     
         6 . The method of  claim 1  wherein the identifiers reflective of when the reading was obtained are selected from Breakfast, Lunch, Dinner, Bedtime, Nighttime, and Other. 
     
     
         7 . The method of  claim 8  wherein the measurements tagged as “Other” are classified based on the classification of the previous measurement and an elapsed time since the previous measurement. 
     
     
         8 . The method of  claim 1  wherein the desired glycemic range is defined as a blood glucose-level measurement between 85 mg/dL and 200 mg/dL. 
     
     
         9 . The method of  claim 1  wherein the steps of the method are repeated over sufficient time to achieve durable glycemic balance. 
     
     
         10 . The method of  claim 1  wherein the patient's insulin dosage regimen is adjusted to include at least one high insulin dose. 
     
     
         11 . The method of  claim 1  wherein the patient's insulin dosage regime is adjusted such that insulin is no longer administered. 
     
     
         12 . A method for treating diabetes mellitus by alleviating glucotoxicity and/or restoring pancreatic beta-cell function in a patient, the method comprising:
 storing one or more components of the patient's insulin dosage regimen;   drawing blood samples from the patient at a plurality of times;   ascertaining the patient's blood glucose-level measurements in said blood samples;   tagging each of said blood glucose-level measurements with an identifier reflective of when said measurement was obtained;   establishing the patient's current glycemic state relative to a desired glycemic range;   determining from the patient's blood glucose-level measurements whether and by how much to adjust at least one component of the one or more components of the patient's present insulin dosage regimen to stay within said desired glycemic range and administer the lowest insulin dosage;   adjusting said at least one component in accordance with said determination in a manner that dampens or prevents unstable oscillations; and   performing said steps of the method until the insulin dosage regimen required to stay within the desired glycemic range is lowered to a predetermined level.   
     
     
         13 . The method of  claim 12  wherein said unstable oscillations are dampened or prevented by ensuring that said adjustment is limited to an intermittent value. 
     
     
         14 . The method of  claim 12  wherein said unstable oscillations are dampened or prevented by ensuring that the current increase in the patient's insulin dosage regimen is less than the previous decrease in the patient's insulin dosage regimen. 
     
     
         15 . The method of  claim 12  wherein said unstable oscillations are dampened or prevented by ensuring that the current decrease in the patient's insulin dosage regimen is less than the previous increase in the patient's insulin dosage regimen. 
     
     
         16 . The method of  claim 12  wherein said unstable oscillations are dampened or prevented by inserting ‘off intervals’ between different directions of dosage adjustments. 
     
     
         17 . The method of  claim 12  wherein said determination of whether and by how much to adjust at least one component of the patient's present insulin dosage regimen is made by calculating the total daily amount of insulin. 
     
     
         18 . The method of  claim 12  wherein said determination of whether and by how much to adjust at least one component of the patient's present insulin dosage regimen is made by calculating the amount by which any component of the dosage is greater than the same component for the previous dosage. 
     
     
         19 . The method of  claim 12  wherein said determination of whether and by how much to adjust at least one component of the patient's present insulin dosage regimen is made by majority voting rule. 
     
     
         20 - 22 . (canceled) 
     
     
         23 . A method for updating a patient's insulin dosage regimen to alleviate glucotoxicity and/or restore pancreatic beta-cell function, the method comprising:
 storing one or more components of the patient's insulin dosage regimen;   drawing blood samples from the patient at a plurality of times;   ascertaining the patient's blood glucose-level measurements in said blood samples;   incrementing a timer based on at least one of the passage of a predetermined amount of time and the receipt of each blood glucose-level measurement;   tagging each of said blood glucose-level measurements with an identifier reflective of when said measurement was obtained;   establishing the patient's current glycemic state relative to a desired glycemic range;   determining from the patient's blood glucose-level measurements whether and by how much at least one component of the one or more components of the patient's present insulin dosage regimen should be adjusted to stay within said desired glycemic range with the lowest insulin dosage;   updating said at least one component in the patient's insulin dosage regime in response to said determination; and   performing the aforementioned steps of the method until the insulin dosage regimen required to stay within the desired glycemic range is lowered to a predetermined level.   
     
     
         24 - 74 . (canceled)