Diagnosis support method, diagnosis support system, and diagnosis support apparatus

• US 8,916,109 B2
• Filed: 03/25/2011
• Issued: 12/23/2014
• Est. Priority Date: 03/26/2010
• Status: Active Grant

• Current Assignee: Sysmex Corporation
• Original Assignee: Sysmex Corporation
• Inventors: Okada, Seiki, Sato, Toshiyuki
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US13/072,076
• Publication Number:
  US 20110237919A1
• Time in Patent Office: 1,369 Days
• Field of Search: 422/68.1, 422/402, 422/403, 422/404
• US Class Current: 422/404
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

A diagnosis support method comprising: obtaining first blood glucose level information at a first time point and/or second blood glucose level information at a second time point which is later, by a predetermined period, than the first time point; placing a collection member, which is configured to collect a tissue fluid, on the skin of the subject for the predetermined period from the first time point to the second time point; obtaining glucose information about an amount of glucose contained in the tissue fluid collected by the collection member; and generating diagnosis support information for supporting a diagnosis of presence or absence of hypoglycemia in the subject, based on the first blood glucose level information and/or the second blood glucose level information and the glucose information. A diagnosis support system and a diagnosis support apparatus are also disclosed.

Claims

1. A diagnosis support system comprising:

a collection member configured to collect a tissue fluid from skin of a subject;

a diagnosis support apparatus, wherein the diagnosis support apparatus comprises;

a detector, located within the diagnosis support apparatus, and configured to obtain glucose information about an amount of glucose contained in the tissue fluid collected by the collection member which is placed on the skin of the subject for a predetermined period from a first time point to a second time point; and

a controller, located within the diagnosis support apparatus, and

a non-transitory memory programmed with instructions which cause the controller to perform an analysis process,

wherein

the analysis process includes;

obtaining a first integrated value related to a glucose amount in the predetermined period, based on the first blood glucose level information and/or the second blood glucose level information and the predetermined period from the first time point to the second time point;

obtaining a second integrated value related to a glucose amount in the body of the subject in the predetermined period from the first time point to the second time point, based on the glucose information; and

generating diagnosis support information for supporting a diagnosis of presence or absence of hypoglycemia in the subject, based on the first integrated value and second integrated value.

2. The system of claim 1, wherein

the analysis process includes obtaining the first integrated value based on the first blood glucose level information and the second blood glucose level information, and

the first integrated value is an area of a region in a blood glucose level-time graph, which region is surrounded by a straight line that is perpendicular to a time axis and that meets the first time point indicated on the time axis, a straight line that is perpendicular to the time axis and that meets the second time point indicated on the time axis;

a straight line that connects the blood glucose level at the first time point and the blood glucose level at the second time point, and the time axis.

3. The system of claim 1, wherein

the second integrated value is calculated based on a concentration of the glucose contained in the tissue fluid collected by the collection member.

4. The system of claim 1, wherein

the analysis process includes outputting the diagnosis support information based on the first integrated value, the second integrated value, and a predetermined condition.

5. The system of claim 4, wherein

the predetermined condition is a predetermined threshold value, and

the analysis process includes generating the diagnosis support information based on the predetermined threshold value and a value that is obtained based on the first integrated value and the second integrated value.

6. The system of claim 5, wherein

the predetermined threshold value is obtained based on the first integrated value and the second integrated value, which are obtained from a subject in whom the presence or absence of hypoglycemia is known.

7. The system of claim 1, further comprising;

a micropore forming device for forming micropores in the skin of the subject.

8. The system of claim 1, wherein

the first time point is before a bedtime when the subject goes to bed;

and

the second time point is after a wake-up time when the subject wakes up.

10. The system of claim 1, wherein

the first blood glucose level information is information about the blood glucose level of the subject before the bedtime of the subject,

the second blood glucose level information is information about the blood glucose level of the subject after the wake-up time of the subject,

obtaining glucose information is obtaining information about an amount of the glucose contained in the tissue fluid collected by the collection member which is placed on the skin of the subject for a period that starts before the bedtime of the subject and ends after the wake-up time of the subject.

11. The system of claim 1, comprising an operation part for inputting the first blood glucose level information, the second blood glucose level information, and the glucose information.

13. The system of claim 1, wherein the collection member is a gel.

9. A diagnosis support apparatus comprising:

a detector configured to obtain glucose information about an amount of glucose contained in a tissue fluid collected by a collection member which is placed on skin of a subject for a predetermined period from a first time point to a second time point;

a controller , located within the diagnosis support apparatus, and

a non-transitory memory programmed with instructions which cause the controller to perform an analysis process,

wherein

the analysis process includes;

obtaining a first integrated value related to a glucose amount in the predetermined period, based on the first blood glucose level information and/or the second blood glucose level information and the predetermined period from the first time point to the second time point;

obtaining a second integrated value related to a glucose amount in the body of the subject in the predetermined period from the first time point to the second time point, based on the glucose information; and

generating diagnosis support information for supporting a diagnosis of presence or absence of hypoglycemia in the subject, based on the first integrated value and the second integrated value.

12. The apparatus of claim 9, comprising an operation part for inputting the first blood glucose level information, the second blood glucose level information, and the glucose information.

14. The apparatus of claim 9, wherein the collection member is a gel.