System for Optimizing a Drug Dosage Regimen Over Time

• US 20170189616A1
• Filed: 03/21/2017
• Published: 07/06/2017
• Est. Priority Date: 05/06/2011
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Petersen, Louise Wagner, Stefansen, Mads Schenstroem, Bengtsson, Henrik, Christensen, Toke Folke
• Granted Patent: US 10,603,437 B2
• Time in Patent Office: Days
• 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:

detecting means that detect when a patient-actuated operation is performed, the operation being indicative of an 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, based on the blood glucose data sets, whether and by how much to vary a component in a present insulin dosage regimen in order to maintain blood-glucose-level measurements within a predefined range, and

output means that communicate to the patient a component in the patient'"'"'s insulin dosage regimen,

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

2. The system of claim 1, comprising a drug delivery assembly, the 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 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. The system of claim 1, comprising a drug delivery assembly, the 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

means that 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, 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 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. The system of claim 1, comprising a drug delivery assembly, the 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 memory means and the processor,

the output means, and

the detecting means,

wherein the detection means 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. The system of 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.