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US 10,293,109 B2Granted
Adaptive system for optimizing a drug dosage regimen over time
AssigneeNovo Nordisk A/S
InventorsHenrik Bengtsson, Anders Dejgaard, Alan Moses
Life of this patent
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Abstract
A system for optimizing a patient's basal insulin dosage regimen over time, adapted to determine from blood glucose values whether and by how much to vary a patient's present recommended amount of the insulin-containing drug in order to maintain the patient's future blood glucose level measurements within a predefined range, and wherein a given blood glucose value is disregarded if no patient-actuated operation being indicative of the administration of a dose of an insulin containing drug has been detected in a pre-defined amount of time prior to the determination of the given blood glucose value.
Claims12
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
- wherein
- IUTitration 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, and
- SF(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.
17 more elements
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
- wherein
- IUTitration 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, and
- SF(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;
- (vi) an insulin expelling mechanism adapted to expel the new titration insulin dose from the reservoir and out through the device;
- and
- (vii) a detection structure adapted to detect when a patient-actuated operation is performed, wherein the operation is indicative of the administration of a dose of an insulin containing drug and is selected from the group consisting of:
- a cap-off event when the cap has been at least partially de-mounted from the drug delivery device for a pre-determined amount of time,
- the size of an expelled dose, and
- when the drug expelling mechanism has been actuated;
- wherein the memory structure is further is adapted to receive data representing detected patient-actuated operations as a function of time;
- and
- wherein the processor is further programmed to calculate a compliance value based on the detected patient-actuated operations compared to a pre-defined schedule for the patient-actuated operations.
24 more elements
Dependencies are inferred from the claim text.