SYSTEM FOR OPTIMIZING A DRUG DOSAGE REGIMEN OVER TIME

• US 20140200545A1
• Filed: 05/02/2012
• Published: 07/17/2014
• Est. Priority Date: 05/06/2011
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Bengtsson, Henrik, Christensen, Toke Folke, Petersen, Louise Wagner, Stefansen, Mads Schenstroem
• Granted Patent: US 9,636,461 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• 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: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: G16H 10/65 stored on portable record carriers, e.g. on smartcards, RFID tags or CD
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

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 system for optimizing a patient'"'"'s basal insulin dosage regimen over time, comprising:

a blood glucose meter for receiving a patient blood sample and generating a blood glucose data set corresponding to a blood glucose value of the patient blood sample,

detecting means for detecting when a patient-actuated operation is performed, the operation being indicative of the administration of a dose of an insulin containing drug,

memory means adapted to store;

blood glucose data sets corresponding to a plurality of blood glucose values as a function of time,

data representing detected patient-actuated operations as a function of time, and

data representing an initial basal insulin dosage regimen,

a processor operatively connected to the memory means, the processor being programmed to determine on the basis of the blood glucose data sets determined at a plurality of times whether and by how much to vary a component in the patient'"'"'s present insulin dosage regimen in order to maintain the patient'"'"'s future blood-glucose-level measurements within a predefined range, and

output means for communicating to the patient a component in the patient'"'"'s insulin dosage regimen,

wherein a given blood glucose data set is disregarded by the processor if no patient-actuated operation has been detected in a pre-defined amount of time prior to the generation of the given data set.

2. A system as in claim 1 in the form of a drug delivery assembly comprising:

a drug delivery device comprising;

a reservoir for a drug,

an outlet for the drug,

a drug expelling mechanism for expelling drug from the reservoir and out through the outlet, and

a cap device releasably mountable on the drug delivery device and adapted to cover the outlet in a mounted position, the cap device comprising;

the blood glucose meter,

the memory means and the processor,

the output means, and

the detecting means,

wherein the detection means 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, a cap-off event being indicative of the administration of a dose of an insulin containing drug.

3. A system as in claim 1 in the form of a drug delivery assembly comprising:

a drug delivery device comprising;

a reservoir for a drug,

an outlet for the drug,

a drug expelling mechanism which can be set to expel a desired dose of drug from the reservoir and out through the outlet when actuated, and

structure to detect, store, and transmit dose data representing the size of an expelled dose, the expelling being indicative of the administration of a dose of an insulin containing drug,

a cap device releasably mountable on the drug delivery device and adapted to cover the outlet in a mounted position, the cap device comprising;

the blood glucose meter,

the memory means and the processor,

the output means, and

the detecting means,

wherein the detection means is adapted to receive dose data from the drug delivery device.

4. A system as in claim 1 in the form of a drug delivery assembly comprising:

a drug delivery device comprising;

a reservoir for a drug,

an outlet for the drug,

a drug expelling mechanism for expelling drug from the reservoir and out through the outlet,

the blood glucose meter,

the memory means and the processor,

the output means, and

the detecting means,

wherein the detection means is adapted to detect when the drug expelling mechanism has been actuated, the expelling being indicative of the administration of a dose of an insulin containing drug, and

a cap device releasably mountable on the drug delivery device and adapted to cover the outlet in a mounted position.

5. A system as in claim 1, wherein a given blood glucose data set is disregarded by the processor if the given blood glucose data set corresponds to a blood glucose value outside a predefined range.

6. A method for optimizing a patient'"'"'s basal insulin dosage regimen over time, comprising:

determining a blood glucose value a plurality of times over time,

detecting when a patient-actuated operation is performed, the operation being indicative of the administration of a dose of an insulin containing drug, and

determining, based on determined blood glucose values, whether and by how much to vary a component in the patient'"'"'s present insulin dosage regimen in order to maintain the patient'"'"'s future blood-glucose-level measurements within a predefined range,

wherein a given blood glucose value is disregarded if no patient-actuated operation has been detected in a pre-defined amount of time prior to the generation of the given blood glucose value.

7. A method as in claim 6, further providing an assembly comprising:

a blood glucose meter,

a drug delivery device, and

a processor configured to determine, based on blood glucose values, whether and by how much to vary a component in a patient'"'"'s insulin dosage regimen in order to maintain the patient'"'"'s future blood-glucose-level measurements within a predefined range.

8. A method as in claim 7, wherein the patient-actuated operation is expelling of a dose of drug from the drug delivery device.

9. A method as in claim 7, wherein the drug delivery device comprises a main part with a drug expelling mechanism and a cap adapted to be releasable mountable on the main part, the patient-actuated operation being the at least partial de-mounting of the cap from the drug delivery device for a pre-determined amount of time.

10. A method as in claim 9, wherein the blood glucose meter is arranged in the cap.