System for use in the treatment of diabetes

• US 8,924,161 B2
• Filed: 08/11/2010
• Issued: 12/30/2014
• Est. Priority Date: 04/01/2003
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Moerman, Piet
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US12/854,706
• Publication Number:
  US 20110034791A1
• Time in Patent Office: 1,602 Days
• US Class Current: 702/19
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A health-monitoring device assesses the health of a user based on levels of two analytes in a biological fluid. A first analyte that is utilized to assess a user'"'"'s health is a fat metabolism analyte, such as ketones, free fatty acids and glycerol, which is indicative of fat metabolism. A second analyte that is utilized is a glucose metabolism analyte, such as glucose. The levels of the two analytes may be used to assess insulin sensitivity, to detect both recent hypoglycemia and the cause of high glucose levels, and/or to guide therapeutic intervention. The dual analyte model may calculate a discrepancy between an actual insulin activity level and a theoretical insulin activity level. The dual analyte model of the present invention may be used to identify individuals at risk for metabolic syndrome, insulin resistance and non-insulin dependent diabetes, and allows monitoring of the progression of those disease states, as well as progress made by therapeutic interventions.

Claims

1. A system for treating diabetes, comprising:

a health-monitoring device, comprising;

a housing;

a test port coupled to the housing and in communication with the housing, wherein the test port is configured to receive a test strip;

a processor coupled to the housing and configured to receive one or more first signals indicative of the concentration of a first analyte and one or more second signals indicative of the concentration of a second analyte in a sample received at the test port, wherein the first analyte is glucose;

a storage unit coupled to the housing and comprising one or more programs executable by the processor, the one or more programs comprising an algorithm for determining an insulin dosage for delivery with a medication delivery device, the algorithm involving the concentration of glucose indicated by the one or more first signals indicative of the concentration of a first analyte and the concentration of the second analyte indicated by the one or more second signals indicative of the concentration of a second analyte; and

a display coupled to the housing to output data resulting from the one or more first and/or second signals and/or an insulin dosage determined by the algorithm.

2. The system of claim 1, wherein the test strip is an electrochemical test strip or a photometric test strip.

3. The system of claim 1, wherein the housing further comprises a data communication port operatively coupled to the processor.

4. The system of claim 3, wherein the data communication port is configured for one or more of electrical communication, acoustic communication, optical communication, or radio wave communication.

5. The system of claim 3, wherein the data communication port is configured for infrared communication.

6. The system of claim 3, wherein the data communication port is configured to communicate with a database at a remote site.

7. The system of claim 6, wherein the data communication port is configured to download data from the database at the remote site through a network.

8. The system of claim 6, wherein the data communication port is configured to upload data to the database at the remote site through a network.

9. The system of claim 8, wherein the data comprises the one or more signals indicative of the concentration of glucose and/or the one or more signals indicative of the concentration of the second analyte in the sample received at the test port.

10. The system of claim 6, wherein the data communication port is configured to download a program to the storage unit through a network.

11. The system of claim 1, wherein the glucose concentration is a blood glucose concentration.

12. The system of claim 11, wherein the display comprises an indicator activatable when the glucose concentration of the sample indicates prospective development of hypoglycemia.

13. The system of claim 11, wherein the display comprises an indicator activatable when the glucose concentration of the sample indicates prospective development of hyperglycemia.

14. The system of claim 11, wherein the processor is configured to provide a preventative recommendation to the user to avoid imminent hypoglycemia through the display.

15. The system of claim 14, wherein the preventative recommendation is consumption of slow absorbing carbohydrates.

16. The system of claim 1, wherein the glucose concentration is a fasting blood glucose concentration.

17. The system of claim 1, wherein the second analyte is a fat metabolism analyte.

18. The system of claim 17, wherein the fat metabolism analyte comprises free fatty acids, ketones, glycerol, or any analyte that is indicative of lipolysis.

19. The system of claim 17, wherein the fat metabolism analyte is a ketone.

20. The system of claim 1, wherein the sample comprises blood, a derivative of blood, interstitial fluid, urine, or saliva.

21. The system of claim 1, wherein the insulin dosage is for insulin administered to a subject.

22. The system of claim 21, wherein the insulin is one of fast acting insulin and long acting insulin.

23. The system of claim 21, wherein the subject is an adolescent subject.

24. The system of claim 1, wherein the display is configured to provide graphic representations and/or text summaries of the output data.

25. The system of claim 1, wherein the display is configured to provide information indicative of food consumption, hypoglycemia, hyperglycemia, or medication dosage.

26. The system of claim 1, wherein the processor is configured to process a daily regimen of output data resulting from the one or more signals and display the output data over the course of a period of time.

27. The system of claim 26, wherein the period of time is at least one month.

28. The system of claim 1, wherein the storage unit comprises an algorithm executable by the processor for determining an insulin resistance factor, the algorithm involving the concentration of glucose indicated by the one or more first signals indicative of the concentration of a first analyte and the concentration of the second analyte indicated by the one or more second signals indicative of the concentration of a second analyte.

29. The system of claim 28, wherein the output data comprises the insulin resistance factor.

30. The system of claim 1, wherein the processor provides for automatic or manual entry of user defined data.

31. The system of claim 30, wherein the user defined data comprises analyte levels, gender, exercise, body mass index, weight, body composition, meal intake, or mediation dosages and times.

32. The system of claim 30, wherein the device comprises a user interface for manual entry of user defined data.

33. The system of claim 32, wherein the user interface comprises one or more buttons.

34. The system of claim 33, wherein the display is configured to display menu options which are navigable using the one or more buttons.

35. The system of claim 1, wherein the health-monitoring device further comprises a sampling device for providing a biological fluid sample from a user.

36. The system of claim 35, wherein the sampling device is a lancet or a needle.

37. The system of claim 35, wherein the sampling device is a lancet and the lancet comprises a variable depth selector for setting the penetration depth of the lancet.

38. The system of claim 37, wherein the diabetes is Type I diabetes.

39. The system of claim 1, comprising a medication delivery device configured to deliver the determined insulin dosage.

40. The system of claim 39, wherein the medication delivery device comprises at least one of a needle, syringe, or injection pen to administer the insulin.

41. The system of claim 1, wherein the health monitoring device is configured to identify one or more patterns in the concentration of glucose and/or the concentration of the second analyte.

42. The system of claim 1, wherein the insulin is fast acting insulin.

43. The system of claim 1, wherein the insulin is long acting insulin.

44. A system for treating diabetes, comprising:

a health-monitoring device, comprising;

a housing;

a test port coupled to the housing and in communication with the housing, wherein the test port is configured to receive a test strip;

a processor coupled to the housing and configured to receive one or more first signals indicative of the concentration of a first analyte and one or more second signals indicative of the concentration of a second analyte in a sample received at the test port;

a storage unit coupled to the housing and comprising one or more programs executable by the processor for determining a dosage of fast and/or long acting insulin based on the concentration of the first analyte indicated by the one or more first signals indicative of the concentration of a first analyte and the concentration of the second analyte indicated by the one or more second signals indicative of the concentration of a second analyte; and

a display coupled to the housing to output data associated with the one or more first and/or second signals and/or a dosage of fast and/or long acting insulin determined by the processor; and

a medication delivery device.

45. The system of claim 44, wherein the diabetes is Type II diabetes.

46. A system for treating diabetes, comprising:

a health-monitoring device, comprising;

a housing;

a test port coupled to the housing and in communication with the housing, wherein the test port is configured to receive an electrochemical test strip;

a processor coupled to the housing and configured to receive one or more first signals indicative of the concentration of glucose and one or more second signals indicative of the concentration of a second analyte in a sample received at the test port;

a storage unit coupled to the housing and comprising one or more programs executable by the processor, the one or more programs comprising an algorithm for determining a dosage of long acting insulin for delivery with a medication delivery device, the algorithm involving the concentration of glucose indicated by the one or more signals indicative of the concentration of glucose and the concentration of the second analyte indicated by the one or more second signals indicative of the concentration of a second analyte; and

a display coupled to the housing to output data resulting from the one or more first and/or second signals and/or a dosage of long acting insulin determined by the algorithm.

47. The system of claim 46, wherein the one or more programs comprise an algorithm for determining a dosage of fast acting insulin for delivery with a medication delivery device, the algorithm involving the concentration of glucose indicated by the one or more first signals indicative of the concentration of glucose and the concentration of the second analyte indicated by the one or more second signals indicative of the concentration of a second analyte in the sample.

48. The system of claim 46, comprising a medication delivery device configured to deliver the determined dosage.

49. A system for treating diabetes, comprising:

a health-monitoring device, comprising;

a housing;

a test port coupled to the housing and in communication with the housing, wherein the test port is configured to receive an electrochemical test strip;

a processor coupled to the housing and configured to receive one or more first signals indicative of the concentration of glucose and one or more second signals indicative of the concentration of a second analyte in a sample received at the test port;

a storage unit coupled to the housing and comprising one or more programs executable by the processor, the one or more programs comprising an algorithm for determining a dosage of fast acting insulin for delivery with a medication delivery device, the algorithm involving the concentration of glucose indicated by the one or more signals indicative of the concentration of glucose and the concentration of the second analyte indicated by the one or more second signals indicative of the concentration of a second analyte; and

a display coupled to the housing to output data resulting from the one or more first and/or second signals and/or a dosage of fast acting insulin determined by the algorithm.

50. The system of claim 49, wherein the one or more programs comprise an algorithm for determining a dosage of long acting insulin for delivery with a medication delivery device, the algorithm involving the concentration of glucose indicated by the one or more signals indicative of the concentration of glucose and the concentration of the second analyte indicated by the one or more second signals indicative of the concentration of a second analyte in the sample.

51. The system of claim 49, comprising a medication delivery device configured to deliver the determined dosage.