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Adaptive system for optimizing a drug dosage regimen over time

  • US 10,293,109 B2
  • Filed: 09/11/2012
  • Issued: 05/21/2019
  • Est. Priority Date: 09/13/2011
  • Status: Active Grant
First Claim
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1. A drug delivery assembly comprising:

  • (i) a memory structure adapted to receive data representing an initial basal insulin dosage regimen and fasting blood glucose values as a function of time over a period from m to n, wherein each of m and n is an integer representing a number of days;

    (ii) a processor operatively connected to the memory structure and programmed to perform a titration process to obtain a new insulin titration dose;

    wherein
    IUTitration level(n)=IUTitration level(n−

    1)+Babystep(n);


    wherein
    Babystep(n)=ISFaverage(n)*(AverageFBG(n)−

    TargetFBG)*SF(FBGVariance); and

    whereinIUTitration level(n) is the new insulin titration dose,IUTitration level(n−

    1) is a previous insulin titration dose,ISFaverage(n) is an average insulin sensitivity factor over the period from n−

    1 to n−

    m,AverageFBG(n) is an average fasting blood glucose over the period from n to n−

    m,TargetFBG is a target fasting blood glucose level, andSF(FBGVariance) is a safety factor value that is a function of the variance of the fasting blood glucose, wherein the value is in the range of 0 to 1; and

    (iii) an output structure adapted to communicate to the patient the new insulin titration dose;

    (iv) an insulin reservoir or structure adapted to receive an insulin reservoir;

    (v) an outlet for the insulin; and

    (vi) an insulin expelling mechanism adapted to expel the new titration insulin dose from the reservoir and out through the device.

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