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

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Bengtsson, Henrik, Dejgaard, Anders, Moses, Alan
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US14/344,250
• Publication Number:
  US 20140371682A1
• Time in Patent Office: 2,443 Days
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

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.

Claims

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

IU_{Titration level}(n)=IU_{Titration level}(n−

1)+Babystep(n);

wherein

Babystep(n)=ISF_average(n)*(Average_FBG(n)−

Target_FBG)*SF(FBG_Variance); and

wherein

IU_{Titration level}(n) is the new insulin titration dose,

IU_{Titration level}(n−

1) is a previous insulin titration dose,

ISF_average(n) is an average insulin sensitivity factor over the period from n−

1 to n−

m,

Average_FBG(n) is an average fasting blood glucose over the period from n to n−

m,

Target_FBG is a target fasting blood glucose level, and

SF(FBG_Variance) 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.

2. The drug delivery assembly according to claim 1, further comprising:

a blood glucose meter structured to receive a patient blood sample and generate fasting blood glucose values as a function of time from patient blood samples; and

a transmission structure adapted to transmit the fasting blood glucose values as a function time to the memory structure.

3. The drug delivery assembly according to claim 1, further comprising:

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;

wherein

the memory structure is further is adapted to receive data representing detected patient-actuated operations as a function of time, and

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.

4. The drug delivery assembly according to claim 3,

wherein the detection structure is adapted to detect 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.

5. The drug device assembly according to claim 3, wherein

the detection structure is adapted to detect, store, and transmit dose data representing the size of an expelled dose,

and wherein the drug device assembly further comprises

a receiving structure adapted to receive the transmitted dose data.

6. The drug delivery assembly according to claim 3,

wherein the detection structure is adapted to detect when the drug expelling mechanism has been actuated.

7. The drug delivery assembly according to claim 1, wherein the processor is further adapted to disregard a blood glucose value if the given blood glucose value corresponds to a blood glucose value outside a predefined range.

8. 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

IU_{Titration level}(n)=IU_{Titration level}(n−

1)+Babystep(n);

wherein

Babystep(n)=ISF_average(n)*(Average_FBG(n)−

Target_FBG)*SF(FBG_Variance); and

wherein

IU_{Titration level}(n) is the new insulin titration dose,

IU_{Titration level}(n−

1) is a previous insulin titration dose,

ISF_average(n) is an average insulin sensitivity factor over the period from n−

1 to n−

m,

Average_FBG(n) is an average fasting blood glucose over the period from n to n−

m,

Target_FBG is a target fasting blood glucose level, and

SF(FBG_Variance) 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.

9. The drug delivery assembly according to claim 8, wherein the patient-actuated operation is 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.

10. The drug device assembly according to claim 8, wherein the patient-actuated operation is the size of an expelled dose.

11. The drug delivery assembly according to claim 8, wherein the patient-actuated operation is when the drug expelling mechanism has been actuated.

12. The drug delivery assembly according to claim 8, further comprising:

a blood glucose meter structured to receive a patient blood sample and generate fasting blood glucose values as a function of time from patient blood samples; and

a transmission structure adapted to transmit the fasting blood glucose values as a function of time to the memory structure.