METHODS OF DETERMINING CONCENTRATION OF KETONE BODIES

• US 20090270764A1
• Filed: 05/08/2009
• Published: 10/29/2009
• Est. Priority Date: 06/27/2000
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Moses, Alan Charles, Buse, John Bernard
• Granted Patent: US 8,532,731 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.

Claims

1-18. -18. (canceled)

19. A method of determining a concentration of ketone bodies in blood, the method comprising steps of:

stimulating a region of skin other than the fingertips by manually rubbing the exterior surface of the region for a duration of at least 1 second;

after stimulating the region of skin, creating an opening in the region of skin for a blood from the region to be accessible through the skin at the region;

coupling a side fill electrochemical sensor strip to a meter where the sensor strip is adapted to transport and receive a blood sample of no more than 1 microliter of blood from the accessible blood in the region and wherein the sensor strip is not a tip fill electrochemical sensor strip;

contacting the sensor strip to the accessible blood in the region;

transporting a blood sample of no more than 1 microliter of blood from the accessible blood to the sensor strip via an un-pressurized mode of transport; and

determining the concentration of ketone bodies in the blood sample using the electrochemical sensor strip and meter.

20. The method of claim 19, wherein the step of creating an opening in the region of skin comprises lancing the region of skin.

21. The method of claim 19, wherein the step of stimulating the region of skin comprises manually rubbing the region of skin for at least five seconds.

22. The method of claim 19, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a forearm.

23. The method of claim 19, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a calf.

24. The method of claim 19, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a thigh.

25. The method of claim 19, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a hand.

26. The method of claim 19, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a portion of an upper arm.

27. The method of claim 19, wherein the step of stimulating the region of skin comprises stimulating a region of skin on an abdomen.

28. The method of claim 19, wherein stimulating the region of skin results in a determination of the concentration of ketone bodies from blood which is at least 10% nearer a concentration determined from blood obtained from a fingertip than a determination of the concentration of ketone bodies from blood obtained from the region of skin without stimulating.

29. The method of claim 28, wherein the fingertip measurement is in the range of 60 to 80 mg/dL.

30. The method of claim 19, wherein the step of transporting no more than 1 microliter of blood sample to the sensor strip comprises transporting no more than 1 microliter of blood sample into a sample chamber of the sensor strip.

31. The method of claim 19, wherein the step of transporting no more than 1 microliter of blood sample to the sensor strip comprises transporting no more than 0.5 microliter of blood sample to the sensor strip.

32. The method of claim 19, wherein the step of transporting no more than 1 microliter of blood sample to the sensor strip comprises transporting no more than 0.25 microliter of blood sample to the sensor strip.

33. The method of claim 19, wherein the step of electrochemically determining the concentration of ketone bodies comprises determining the concentration of ketone bodies using coulometry.

34. The method of claim 19, wherein the step of electrochemically determining the concentration of ketone bodies comprises determining the concentration of ketone bodies using amperometry.

35. The method of claim 19, wherein the step of electrochemically determining the concentration of ketone bodies comprises determining the concentration of ketone bodies using potentiometry.

36. A method of determining a concentration of ketone bodies in blood, the method comprising steps of:

stimulating a region of skin other than the fingertips by manually rubbing the skin for a period of time adequate to obtain a ketone bodies measurement that is at least 10% nearer a concentration determined from blood obtained from a fingertip measurement than a determination of the concentration of ketone bodies from blood obtained from the region of skin without stimulating;

after stimulating the region of the skin, lancing the skin to cause a flow of blood from the region;

coupling an electrochemical sensor strip to a meter;

contacting the sensor strip to the blood and transporting no more than about 1 microliter of the blood to a sample chamber in the sensor strip; and

electrochemically determining the concentration of ketone bodies using coulometry, amperometry or potentiometry.

37. The method of claim 36, wherein the step of stimulating the region of skin comprises manually rubbing the forearm skin for a period of at least one second.

39. The method of claim 36, wherein the step of stimulating the region of skin comprises manually rubbing the forearm skin for a period of at least 5 seconds.

40. The method of claim 36, wherein the step of transporting no more than about 1 microliter of the blood to a sample chamber in the sensor strip comprises transporting no more than about 0.5 microliter of the blood.

41. The method of claim 40, wherein the step of transporting no more than about 0.5 microliter of the blood comprises transporting no more than about 0.25 microliter of the blood.

42. The method of claim 41, wherein the step of transporting no more than about 0.25 microliter of the blood comprises transporting no more than about 0.1 microliter of the blood.

43. The method of claim 36, wherein the step of coupling an electrochemical sensor strip comprises coupling a tip-fill electrochemical sensor strip.

44. The method of claim 36, wherein the step of coupling an electrochemical sensor strip comprises coupling a side-fill electrochemical sensor strip.

45. The method of claim 36 wherein the fingertip measurement is in the range of 60 to 80 mg/dL.

46. The method of claim 36, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a forearm.

47. The method of claim 36, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a calf.

48. The method of claim 36, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a thigh.

49. The method of claim 36, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a hand.

50. The method of claim 36, wherein the step of stimulating the region of skin comprises stimulating a region of skin on a portion of an upper arm.

51. The method of claim 36, wherein the step of stimulating the region of skin comprises stimulating a region of skin on an abdomen.