Adaptive System for Optimizing a Drug Dosage Regimen Over Time

• US 20140371682A1
• Filed: 09/11/2012
• Published: 12/18/2014
• 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
• Granted Patent: US 10,293,109 B2
• Time in Patent Office: Days
• US Class Current: 604/189
• 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 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,

memory means adapted to receive;

data representing an initial basal insulin dosage regimen, and

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

a processor operatively connected to the memory means, the processor being programmed to determine from 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 the determined variation in the component in the patient'"'"'s insulin dosage regimen,

wherein the processor is programmed to calculate;

a correction value representing, for blood glucose data sets determined at a plurality of times, the degree of deviation between determined and expected values,

wherein the calculated variation of the component is reduced as a function of the calculated correction value.

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

a drug delivery device comprising;

a drug reservoir or means for receiving a drug reservoir,

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, and

the output means.

3. A system as in claim 1 in the form of an assembly comprising:

a drug delivery device unit comprising;

a drug reservoir or means for receiving a drug reservoir,

an outlet for the drug,

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

the memory means and the processor,

receiving means for receiving blood glucose data from the blood glucose meter, and

the output means,

a second device unit comprising;

the blood glucose meter, and

transmission means for transmitting blood glucose data to the drug delivery device unit.

4. A system as in claim 1, further comprising:

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,

wherein;

the memory means is adapted to receive data representing detected patientactuated operations as a function of time,

the processor is programmed to further calculate a compliance value based on detected patient-actuated operations compared to a pre-defined schedule for the patientactuated operations, and

the calculated variation of the component is reduced as a function of the compliance value.

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

a drug delivery device comprising;

a drug reservoir or means for receiving a drug reservoir,

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.

6. A system as in claim 4 in the form of an assembly comprising:

a drug delivery device unit comprising;

a drug reservoir or means for receiving a drug reservoir,

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

means for detecting, storing and transmitting dose data representing the size of an expelled dose,

a second device unit comprising;

the blood glucose meter,

the memory means and the processor,

the output means, and

receiving means for receiving dose data from the drug delivery device.

7. A system as in claim 6, wherein the second device unit is in the form of a cap device releasably mountable on the drug delivery device and adapted to cover the outlet in a mounted position.

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

a drug delivery device comprising;

a drug reservoir or means for receiving a drug reservoir,

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, and

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

9. 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.