TAILORED BASAL INSULIN DELIVERY SYSTEM AND METHOD

• US 20120109047A1
• Filed: 12/30/2011
• Published: 05/03/2012
• Est. Priority Date: 06/25/2007
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Shapira, Gali, Gescheit, Iddo
• Application Number:
  US13/341,576
• Publication Number:
  US 20120109047A1
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Disclosed is a system to deliver insulin to a user'"'"'s body. The system includes a dispensing unit to deliver the insulin to the body, and a control mechanism to control delivery of basal insulin according to a predetermined basal infusion pattern, the basal infusion pattern selected from a plurality of predetermined basal infusion patterns. In some embodiments, selection of the basal infusion pattern may be based on one or more personal characteristics of the user.

Claims

15. A method of delivering basal insulin to a patient'"'"'s body comprising the steps of:

determining a first basal infusion pattern from a plurality of predetermined basal infusion patterns;

updating the first basal pattern to a second basal pattern; and

delivering insulin to the body of the user based on the second basal infusion pattern.

1. A system for delivery insulin to a user'"'"'s body, the system comprising:

a dispensing unit to deliver the insulin to the body; and

a control mechanism to control delivery of basal insulin according to a first basal infusion pattern, the control mechanism being adapted to update the first basal infusion pattern to a second basal infusion pattern.

2. The system of claim 1, wherein the control mechanism is configured to update the first basal infusion pattern based on one or more personal characteristics of the user, the personal characteristics comprising at least one of:

age, body-mass index (BMI), bolus insulin requirements, sex, duration of diabetes, metabolic control, physical activity, sleep pattern, sleep duration, hemoglobin AlC values, age at manifestation of Diabetes Mellitus (DM), pyramidal insulin per kilogram, prandial insulin per day, total insulin per kilogram and total insulin per day.

3. The system of claim 1, wherein the control mechanism is configured to update the first basal infusion pattern based at least in part on the measured blood glucose levels of the user.

4. The system of claim 1, wherein the first basal infusion pattern is initially selected from a collection of predefined patterns.

5. The system of claim 1, wherein the first basal infusion pattern is updated to the second basal infusion pattern automatically by the control mechanism.

6. The system of claim 1, wherein the second basal infusion pattern is electronically sent to a practitioner for validation.

7. The system of claim 1, wherein the second basal infusion pattern comprises the first basal infusion pattern shifted in time.

8. The system of claim 1, wherein the control mechanism is configured to evaluate the suitability of the first basal infusion pattern.

9. The system of claim 8, wherein the evaluation is based on a determination of the glycemic status of the patient.

10. The system of claim 8, wherein the evaluation is based on data representative of deviations of a user'"'"'s glucose level from a target zone or on periodic data of hemoglobin AlC levels or on continuous glucose measurements.

11. The system of claim 1, wherein the dispensing unit comprises:

a reservoir for storing the insulin;

a cannula having an end for placement within the user'"'"'s body; and

a pump to deliver the insulin from the reservoir to the cannula.

12. The system of claim 1, wherein the control mechanism comprises a processor configured to control delivery of the basal insulin by the pump according to the basal infusion pattern.

13. The system of claim 1, further comprising a glucometer to measure blood glucose levels of the user.

14. The system of claim 1, wherein the basal pattern is the distribution of amounts of basal insulin per hour over a 24-hour period.

16. The method of claim 15, wherein the step of updating is based on one or more personal characteristics of the user, including one or more of:

age, body-mass index (BMI), bolus insulin requirements, sex, duration of diabetes, metabolic control, physical activity, sleep pattern, sleep duration, hemoglobin AlC values, age at manifestation of Diabetes Mellitus (DM), pyramidal insulin per kilogram, prandial insulin per day, total insulin per kilogram and total insulin per day

17. The method of claim 15, wherein the step of updating is based at least in part on the measured blood glucose levels of the user.

18. The method of claim 15, further comprising evaluating the suitability of the first basal infusion pattern.

19. A computer program comprising computer-executable instructions, which when executed on a suitable computer device, performs the method of claim 15.

20. A non-transitory computer readable medium comprising computer-executable instructions recorded thereon for performing the method of claim 15.

17-1. The method of claim 15, wherein the second basal infusion pattern is the first basal infusion pattern shifted in time.