Method and Device for Utilizing Analyte Levels to Assist in the Treatment of Diabetes

• US 20110034791A1
• Filed: 08/11/2010
• Published: 02/10/2011
• Est. Priority Date: 04/01/2003
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Moerman, Piet
• Granted Patent: US 8,924,161 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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

1-20. -20. (canceled)

21. A system for use in treating Type II 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 element;

a processor coupled to the housing and configured to receive one or more signals associated with an analyte sample received at the test port;

a storage unit coupled to the housing and configured to store one or more programs executable by the processor for determining a medication dosage information based at least in part on the one or more signals associated with the analyte sample; and

a display coupled to the housing to output data associated with the one or more signals associated with an analyte sample and/or the determined medication dose information; and

a medication administration device.

22. The system of claim 21, wherein the program comprises an algorithm for determining the medication dosage information.

23. The system of claim 21, wherein the medication administration device comprises at least one of a needle, syringe, or injection pen to administer the medication.

24. The system of claim 21, wherein the test element is a test strip.

25. The system of claim 24, wherein the test strip is an electrochemical test strip or a photometric test strip.

26. The system of claim 21, wherein the test element is a skin inserted device.

27. The system of claim 21, wherein the housing further comprises a data communication port operatively coupled to the processor.

28. The system of claim 27, wherein the data communication port includes one or more of electrical communication, acoustic communication, optical communication, or radio wave communication.

29. The system of claim 27, wherein the data communication port is configured for infrared communication.

30. The system of claim 27, wherein the data communication port is configured to communicate with a database at a remote site.

31. The system of claim 30, wherein the data communication port is configured to download data from the database at the remote site through a network.

32. The system of claim 30, wherein the data communication port is configured to upload data to the database at the remote site through a network.

33. The system of claim 30, wherein the data communication port is configured to download a program to the storage unit through a network.

35. The system of claim 21, wherein the one or more signals associated with an analyte sample are indicative of an analyte concentration in the sample.

36. The system of claim 35, wherein the analyte concentration is a blood glucose concentration.

37. The system of claim 35, wherein the device continuously measures the analyte concentration.

38. The system of claim 35, wherein the analyte concentration is a fasting blood glucose concentration.

39. The system of claim 21, wherein the processor is configured to receive at least a first signal associated with a first analyte and a second signal associated with a second analyte.

40. The system of claim 39, wherein the first analyte is glucose and the second analyte is a fat metabolism analyte.

41. The system of claim 40, wherein the fat metabolism analyte comprises free fatty acids, ketones, glycerol, or any analyte that is indicative of lipolysis.

42. The system of claim 40, wherein the fat metabolism analyte is a ketone.

43. The system of claim 21, wherein the sample comprises blood, a derivative of blood, interstitial fluid, urine, or saliva.

44. The system of claim 21, wherein the medication dosage information is for a medication administered to a subject.

45. The system of claim 44, wherein the medication is insulin.

46. The system of claim 44, wherein the medication includes one or more of fast acting insulin and long acting insulin.

47. The system of claim 44, wherein the subject is an adolescent subject.

48. The system of claim 21, wherein the display is configured to provide graphic representations and/or text summaries of the output data.

49. The system of claim 21, wherein the display is configured to provide information relating to food consumption, hypoglycemia, hyperglycemia, or medication dosage.

50. The system of claim 21, wherein the processor is configured to process a daily regimen of output data associated with the one or more signals associated with an analyte sample and display the output data over the course of a period of time.

51. The system of claim 50, wherein the period of time is at least one month.

52. The system of claim 21, wherein the storage unit is further configured to comprise an algorithm executable by the processor for determining an insulin resistance factor based at least in part on the one or more signals associated with the analyte sample.

53. The system of claim 52, wherein the output data comprises the insulin resistance factor associated with the one or more signals associated with an analyte sample.

54. The system of claim 21, wherein the processor provides for automatic or manual entry of user defined data.

55. The system of claim 54, wherein the device comprises a user interface for manual entry of user defined data.

56. The system of claim 55, wherein the user interface comprises one or more buttons.

57. The system of claim 56, wherein the display is configured to display menu options which are navigable using the one or more buttons.

58. The system of claim 54, wherein the user defined data comprises analyte levels, gender, exercise, body mass index, weight, body composition, meal intake, or mediation dosages and times.

59. The system of claim 36, wherein the display comprises an indicator activatable when the glucose concentration of the sample indicates prospective development of hypoglycemia.

60. The system of claim 36, wherein the display comprises an indicator activatable when the glucose concentration of the sample indicates prospective development of hyperglycemia.

61. The system of claim 36, wherein the processor is configured to provide a preventative recommendation to the user to avoid imminent hypoglycemia through the display.

62. The system of claim 61, wherein the preventative recommendation is consumption of slow absorbing carbohydrates.

63. The system of claim 21, wherein the health-monitoring device further comprises a sampling device for providing a biological fluid sample from a user.

64. The system of claim 63, wherein the sampling device is a lancet or a needle.

65. The system of claim 63, wherein the sampling device is a lancet and the lancet comprises a variable depth selector for setting the penetration depth of the lancet.

67. The system of claim 65, wherein the diabetes is Type II diabetes.

66. A system for use in treating diabetes with injections, 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 element;

a processor coupled to the housing and configured to receive one or more signals associated with an analyte sample received at the test port;

a storage unit coupled to the housing and configured to store one or more programs executable by the processor for determining a medication dosage information based at least in part on the one or more signals associated with the analyte sample; and

a display coupled to the housing to output data associated with the one or more signals associated with an analyte sample and/or the determined medication dose information; and

a medication administration device.