System for optimizing a patient's drug dosage regimen over time

• US 9,619,625 B2
• Filed: 03/29/2012
• Issued: 04/11/2017
• Est. Priority Date: 03/30/2011
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Bengtsson, Henrik
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US14/008,911
• Publication Number:
  US 20140094743A1
• Time in Patent Office: 1,839 Days
• Field of Search: 604 65- 67, 604131, 604151
• 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 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: F04C 2270/041 Controlled or regulated
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• 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 (a) 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 (b) at the same time display blood glucose value data and the recommended amount data as a function of time.

Claims

1. A system for optimizing a patient'"'"'s basal insulin dosage regimen over time, comprising a patient unit and a display unit, the patient unit comprising:

a blood glucose meter for determining a blood glucose value from a blood sample,

first controller and memory apparatus adapted to;

store data representing an initial basal insulin dosage regimen, the dosage regimen comprising a recommended amount of an insulin-containing drug to be taken at recommended intervals,

determine from blood glucose values determined at a plurality of times whether and by how much to vary the 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

create a blood glucose value log representing blood glucose values as a function of time,

and

structure to transmit log data to the display unit,

the display unit comprising;

structure to receive the log data,

display apparatus,

second controller and memory apparatus adapted to;

store the received log data, and

control the display apparatus to at the same time display the blood glucose value log data and a recommended amount log as a function of time.

2. A system as in claim 1, wherein the recommended amount log is calculated by the second controller and memory apparatus based on the received blood glucose value log.

3. A system as in claim 1, wherein the first controller and memory apparatus are adapted to create the recommended amount log, the recommended amount log representing recommended amounts as a function of time.

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

a drug delivery device comprising;

a drug reservoir or structure to receive a drug reservoir,

an outlet for the drug, and

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

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

5. A system as in claim 4, wherein the cap comprises the blood glucose meter, the first controller and memory apparatus, and the structure to transmit log data, the cap thereby forming the patient unit.

6. A system as in claim 4, wherein the first controller and memory apparatus is further 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, and

create a cap-off log representing detected cap-off events as a function of time.

7. A system as in claim 6, wherein the second controller and memory apparatus is adapted to control the display apparatus to additionally display the cap-off time log as a function of time.

8. A system as in claim 4, wherein

the drug expelling mechanism can be set to expel a desired dose of drug when actuated, the first controller and memory apparatus being further adapted to detect the size of an expelled dose and create dose log representing detected dose sizes as a function of time, and

the second controller and memory apparatus is adapted to control the display apparatus to additionally display the dose log as a function of time.