DEVICES, SYSTEMS AND METHODS FOR QUANTIFYING BOLUS DOSES ACCORDING TO USER PARAMETERS

• US 20120283694A1
• Filed: 09/16/2010
• Published: 11/08/2012
• Est. Priority Date: 09/18/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Mendingo Limited
• Inventors: Shapira, Gali, Gescheit, Iddo M., Yodfat, Ofer
• Granted Patent: US 9,919,105 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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: G16H 20/17 delivered via infusion or injection

Abstract

Devices, systems and methods for determining a recommended bolus dose of therapeutic fluid to be delivered to the body are disclosed. Such a recommended bolus dose may be provided by establishing an initial bolus dose for a user based on one or more first parameters relating to the user and adjusting (e.g., increasing or decreasing) this initial bolus dose amount based on one or more second user parameters by multiplying the initial bolus dose by one or more multiplier values that correlate to at least one of the second parameters and/or by adding or subtracting an absolute value of at least one of the second parameters from the initial bolus dose amount.

Claims

1-49. -49. (canceled)

50. A method for determining a bolus dose of therapeutic fluid to be delivered to the body of a user, the method comprising:

receiving a current blood glucose level (CBG) of the user;

receiving a BG trend including a direction and/or rate of change of blood glucose level (BG) of the user;

receiving one or more first additional parameters relating to the user; and

determining a bolus dose to be delivered to the body of the user based on at least one of the CBG, the BG trend and the one or more first additional parameters relating to the user, such that delivering the bolus dose to the user compensates for a change in a BG level of the user.

51. The method of claim 50, wherein the one or more first additional parameters relating to the user are selected from a group consisting of insulin sensitivity (IS), carbohydrate-to-insulin ratio (CIR), target blood glucose level (TBG), an amount of carbohydrate to be consumed (TC), and residual insulin (RI).

52. The method of claim 51, wherein the one or more parameters relating to the user are further selected from a group consisting of:

glycemic index (GI), fat content of the meal, and fiber content of the meal.

53. The method of claim 50, wherein the CBG is measured via a continuous glucose monitor (CGM).

54. The method of claim 50, wherein the BG trend is received from a continuous glucose monitor (CGM).

55. The method of claim 50, wherein at least one of the one or more first additional parameters relating to the user, the CBG and the BG trend is received via a user interface.

56. The method of claim 50, wherein determining the bolus dose comprises:

determining an initial bolus dose of therapeutic fluid based on the one or more first additional parameters relating to the user and the CBG; and

determining the bolus dose based on the initial bolus dose and one or more multiplier values.

57. The method of claim 56, wherein determining the bolus dose includes multiplying the initial bolus dose by the one or more multiplier values.

58. The method of claim 56, further comprising retrieving, from a memory, one or more multiplier values correlating to the BG trend.

59. The method of claim 50, wherein determining the bolus dose comprises:

determining an initial bolus dose of therapeutic fluid based on the one or more first additional parameters relating to the user and the CBG; and

determining a bolus dose based on the initial bolus dose and one or more absolute values.

60. The method of claim 59, wherein determining the bolus dose includes adding or subtracting the one or more absolute values to or from the initial bolus dose.

61. The method of claim 59, further comprising retrieving, from a memory, one or more absolute values corresponding to the BG trend.

62. The method of claim 56, wherein the one or more multiplier values are greater than 1 when the BG trend is increasing;

the one or more multiplier values are less than 1 when the BG trend is decreasing; and

the one or more multiplier values substantially equal 1 when the BG level is substantially constant.

63. The method of claim 59, wherein:

the one or more absolute values are added when the BG trend is increasing;

the one or more the absolute values are subtracted when the BG trend is decreasing; and

the one or more absolute values substantially equals 0 when the BG level is substantially constant.

64. The method of claim 56, wherein the one or more multiplier values are determined based on a mathematical function that correlates the BG trend with the one or more multiplier values.

65. The method of claim 59, wherein the one or more absolute values are determined based on a mathematical function that correlates the BG trend with the one or more absolute values.

66. The method of claim 50, further comprising notifying the user regarding the bolus dose.

67. The method of claim 50, further comprising delivering the therapeutic fluid according to the bolus dose.

68. The method of claim 50, further comprising:

receiving one or more second additional parameters relating to the user, the one or more second additional parameters being selected from a group consisting of physical activity level, emotional stress level, blood ketones level and/or trend, blood pH level and/or trend, presence of an illness and/or menstruation and body temperature; and

determining a bolus dose that compensates for a change in the BG level and/or the one or more second additional parameters.

69. The method of claim 56, wherein determining the bolus dose comprises:

averaging a plurality of multiplier values of the one or more multiplier values, wherein at least one of the one or multiplier values correlates to the BG trend; and

determining the bolus dose includes determining the bolus dose based on the initial bolus dose and the average of the plurality of multiplier values.

70. The method of claim 50, further comprising adjusting a timing and/or duration associated with the bolus dose based on at least the BG trend.

71. The method of claim 50, further comprising determining an initial bolus dose for the user based on at least one of the one or more first additional parameters relating to the user and the CBG and determining the bolus dose based on the initial bolus dose and the BG trend, wherein:

the bolus dose is less than the initial bolus dose if the BG trend is decreasing;

the bolus dose is greater than the initial bolus dose if the BG trend is increasing; and

the bolus dose substantially equals the initial bolus dose if the BG level of the user is substantially constant.

72. The method of claim 50, wherein delivering the bolus dose to the user compensates for a rate of the change in the BG level of the user.

73. The method of any of claims 50, wherein the therapeutic fluid comprises insulin.