CLIAMS:We claim:
1. A method for mapping glucose metabolism and its abnormalities, the method comprising of
plotting glucose levels and insulin levels on a two dimensional graph by a Glucose Metabolism Matrix (GMM) module, on the Glucose Metabolism Matrix (GMM) receiving at least one glucose level and corresponding insulin levels, wherein the two dimensional graph is divided into a plurality of sectors; and
plotting a polygon by the GMM module around a plurality of points corresponding to plotted glucose and insulin levels on the two dimensional graph.
2. The method, as claimed in claim 1, wherein the two dimensional graph is divided into nine sectors.
3. The method, as claimed in claim 2, wherein the nine sectors are arranged in a 3x3 matrix.
4. A Glucose Metabolism Matrix (GMM) module for mapping glucose metabolism and its abnormalities, the GMM module configured for
plotting glucose levels and insulin levels on a two dimensional graph, on the Glucose Metabolism Matrix (GMM) receiving at least one glucose level and corresponding insulin levels, wherein the two dimensional graph is divided into a plurality of sectors; and
plotting a polygon around a plurality of points corresponding to plotted glucose and insulin levels on the two dimensional graph.
5. The GMM module, as claimed in claim 4, wherein the GMM module is configured for dividing the two dimensional graph into nine sectors.
6. The GMM module, as claimed in claim 5, wherein the GMM module is configured for arranging the nine sectors in a 3x3 matrix.

Dated: 16-05-2013 Signature:
Vikram Pratap Singh Thakur
Patent Agent
,TagSPECI:FORM 2
The Patent Act 1970
(39 of 1970)
&
The Patent Rules, 2005

COMPLETE SPECIFICATION
(SEE SECTION 10 AND RULE 13)

TITLE OF THE INVENTION

“Method and System for mapping the condition and prognosis of glucose metabolism and its abnormalities”
APPLICANTS:

Name : HCL Technologies Limited

Nationality : Indian

Address : HCL Technologies Ltd.
50-53 Greams Road, Chennai – 600006, Tamil Nadu, India

The following specification particularly describes and ascertains the nature of this invention and the manner in which it is to be performed:-

FIELD OF INVENTION
[001] This invention relates to medical monitoring systems and more particularly to monitoring glucose metabolism rates in a human body.

BACKGROUND OF INVENTION
[002] Glucose serves an important role in the normal functioning of a human body. Glucose acts both as a source of energy and as a source of starting material for most biosynthetic reactions. The glucose metabolized is used by organs such as the brain (which consumes about 60-70% of the total glucose metabolized by the body), the heart, the skeletal tissues, the pancreas, the liver and so on.
[003] Also, consider diabetes is a disease that is among the fastest disease affecting a large majority of the population in both the developed and developing worlds. While, there is no outright cure for diabetes, it may be controlled by monitoring the glucose levels of an affected person. The control measures comprising of insulin injections, medicines, diet and so on may be modified as per the current glucose levels of the affected person.
[004] Hence in light of the above reasons, monitoring of glucose metabolism is very vital. However, the current process of monitoring and management of glucose levels is reactive and not pro-active. The overview and insights which will give more information about the state of the disease conditions are lacking. The disease modifying capacity of a medical, surgical or lifestyle intervention and the understanding of its tendency to alter the progression of the disease is less robust. Moreover, the focus seems to be too much on diabetes which is just part of a spectrum of diseases which may be affected by glucose metabolism.

OBJECT OF INVENTION
[005] The principal object of this invention is to propose a method and system to map a metabolic defect and understand its progress in a holistic way with particular emphasis to understand the prognosis of the disease, which will lead to improved monitoring, management, therapeutics and research of the condition in timely manner.

STATEMENT OF INVENTION
[006] Accordingly the invention provides a method for a method for mapping glucose metabolism and its abnormalities, the method comprising of plotting glucose levels and insulin levels on a two dimensional graph by a Glucose Metabolism Matrix (GMM) module, on the Glucose Metabolism Matrix (GMM) receiving at least one glucose level and corresponding insulin levels, wherein the two dimensional graph is divided into a plurality of sectors; and plotting a polygon by the GMM module around a plurality of points corresponding to plotted glucose and insulin levels on the two dimensional graph.
[007] Also disclosed herein is a Glucose Metabolism Matrix (GMM) module for mapping glucose metabolism and its abnormalities, the GMM module configured for plotting glucose levels and insulin levels on a two dimensional graph, on the Glucose Metabolism Matrix (GMM) receiving at least one glucose level and corresponding insulin levels, wherein the two dimensional graph is divided into a plurality of sectors; and plotting a polygon around a plurality of points corresponding to plotted glucose and insulin levels on the two dimensional graph.
[008] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.

BRIEF DESCRIPTION OF FIGURES
[009] This invention is illustrated in the accompanying drawings, through out which like reference letters indicate corresponding parts in the various figures. The embodiments herein will be better understood from the following description with reference to the drawings, in which:
[0010] FIGs. 1a, 1b and 1c depict a system for mapping the condition and prognosis of glucose metabolism and its abnormalities using a two dimensional graph plot (with blood insulin levels on one axis and blood glucose level on the other axis), according to embodiments as disclosed herein;
[0011] FIG. 2 depicts a plot of a two dimensional graph plot with blood insulin levels on one axis and blood glucose level on the other axis, according to embodiments as disclosed herein;
[0012] FIG. 3 depicts a GMM, according to embodiments as disclosed herein;
[0013] FIG. 4 depicts a GMM module, according to embodiments as disclosed herein;
[0014] FIG. 5 is a flowchart depicting the process of creating a GMM, according to embodiments as disclosed herein;
[0015] FIG. 6 represents exemplary insulin and glucose values on GMM in a healthy adult, according to embodiments as disclosed herein;
[0016] FIG. 7 represents exemplary insulin and glucose values on GMM in a pre-diabetic, according to embodiments as disclosed herein;
[0017] FIG. 8 represents exemplary insulin and glucose values on GMM in a type 2 diabetic, according to embodiments as disclosed herein;
[0018] FIG. 9 represents exemplary insulin and glucose values on GMM in a type 1 diabetic, according to embodiments as disclosed herein;
[0019] FIG. 10 represents exemplary insulin and glucose values on GMM in a patient with insulinoma, according to embodiments as disclosed herein; and
[0020] FIG. 11 represents exemplary insulin and glucose values on GMM in prolonged fasting status, according to embodiments as disclosed herein

DETAILED DESCRIPTION OF INVENTION
[0021] The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
[0022] The embodiments herein propose a method and system for mapping the condition and prognosis of glucose metabolism and its abnormalities using a two dimensional graph plot (with blood insulin levels on one axis and blood glucose level on the other axis), which will give a theoretical construct of the full spectrum of glucose metabolism. Referring now to the drawings, and more particularly to FIGS. 1 through 11, where similar reference characters denote corresponding features consistently throughout the figures, there are shown preferred embodiments.
[0023] FIGs. 1a, 1b, 1c and 1d depict a system for mapping the condition and prognosis of glucose metabolism and its abnormalities using a two dimensional graph plot (with blood insulin levels on one axis and blood glucose level on the other axis), according to embodiments as disclosed herein. The system, as depicted, comprises of a GMM module 101 and a glucose measurement device 102. The glucose measurement device 102 enables a user to measure the glucose levels of the user. The glucose measurement device 102 may be any device such as a portable handheld glucose meter, a continuous glucose meter, a hospital/medical lab based glucose meter or any other device capable of measuring the glucose levels of the user. The GMM module 101 may be connected to the glucose measurement device 102 using a wired means (as depicted in FIG. 1a) or using a wireless means (as depicted in FIG. 1b). When the GMM module 101 is connected to the glucose measurement device 102 using the wired means, the wired means may comprise of a USB cable (regular/micro/mini), a HD cable, a LAN cable, a networking cable and so on. The wireless means may comprise of a mobile communication network, a Wi-Fi network, a Bluetooth link, a NFC link, a Wi-Fi direct link, a ZigBee link and so on. The GMM module 101 may be connected to the glucose measurement device 102 using the internet (as depicted in FIG. 1d). The GMM module 101 may be present within the glucose measurement device 101 (as depicted in FIG. 1c). In an embodiment herein, the GMM module 101 may be a device such as a mobile phone, a tablet, a laptop, a desktop computer, a PDA (Personal Digital Assistant) and so on.
[0024] The GMM module 101, on receiving at least one glucose level reading and the corresponding insulin levels from the glucose measurement device 102, plots the glucose levels and the insulin levels on a two dimensional graph plot (as depicted in FIG. 2). In FIG. 2, the glucose levels are depicted on the X-axis and the insulin levels are depicted on the Y-axis. In another embodiment herein, the glucose levels may be depicted on the Y-axis and the insulin levels may be depicted on the X-axis. The area of the graph plot is divided into 9 sectors in the form of a 3x3 matrix (as depicted in FIG. 3), hereinafter referred to as a Glucose Metabolism Matrix (GMM). The 3x3 matrix is used as the values of insulin levels can be broadly categorized into hypo, normo and hyper insulinemia (low, normal and high insulin levels respectively and the glucose levels can be categorized into hypo, normo and hyper glycemia respectively. The GMM module 101 plots a polygon around the plotted values to provide the range of values for that particular person, wherein the polygon represents the outer bound of glucose and insulin values taken from a person, wherein the readings may be taken on multiple days during different parts of the day including fasting and post prandial readings.
[0025] FIG. 4 depicts a GMM module, according to embodiments as disclosed herein. The GMM module 101, as depicted comprises of a controller 401, a mapping module 402 and a database 403. The controller 401, on receiving at least one glucose level reading and the corresponding insulin levels from the glucose measurement device 102, sends the received readings to the mapping module 402. The controller 401 may also store the received readings in a database 403. The database 403 may be a memory or any suitable storage location. The database 403 may be present internal to the GMM module 101. The database 403 may be co-located with the GMM module 101. The database 403 may also be located remotely from the GMM module 101 and may connect to the GMM module 101 using a suitable means. In an embodiment herein, the controller 401 may wait to receive a pre-defined threshold number of samples, before initiating the mapping. The mapping module 402 plots the glucose levels and the insulin levels on a two dimensional graph plot (as depicted in FIG. 2). The controller 401 plots a polygon around the plotted values to provide the range of values for that particular person, wherein the polygon represents the outer bound of glucose and insulin values taken from a person, wherein the readings may be taken on multiple days during different parts of the day including fasting and post prandial readings.
[0026] The controller 401 may display the GMM on a display interface. The display interface may be present on the GMM module 101, the glucose measurement module 102 or any other device with a display and which may communicate with the GMM module 101. The GMM module 101 may also display the GMM on more than one device, such as on a device belonging to the person, the device belonging to the physician and so on.
[0027] The controller 401 may print the GMM using a printer, associated with the GMM module 101. The controller 401 may also email the GMM to a pre-configured email identity, wherein the pre-configured email identity may be an authorized stakeholder such as physician, guardian and so on.
[0028] The controller 401 may store the GMM in a suitable location such as the database 403 or any other suitable memory location.
[0029] In an embodiment herein, based on the plotted polygon, the controller 401 may estimate a disease which the person who provided the readings may suffer from. The controller 401 may also provide a clinical evaluation of the person, based on the polygon.
[0030] The controller 401 may also comprise a means for enabling multiple users to use the GMM module 101, wherein each person has an ID (which may be a unique number, name of the person, birth date, email address) and the person has to enter the ID of the person whose reading is being received. There may also be a means such as a password, biometric means and so on to provide security. The controller 401 may store/display the corresponding records, GMM and so on using the associated ID of the person.
[0031] FIG. 5 is a flowchart depicting the process of creating a GMM, according to embodiments as disclosed herein. The GMM module 101, on receiving (501) at least one glucose level reading and the corresponding insulin levels from the glucose measurement device 102, plots (502) the glucose levels and the insulin levels on a two dimensional graph plot (as depicted in FIG. 2). The GMM module 101 plots (503) a polygon around the plotted values to provide the range of values for that particular person, wherein the polygon represents the outer bound of glucose and insulin values taken from a person, wherein the readings may be taken on multiple days during different parts of the day including fasting and post prandial readings. The various actions in method 500 may be performed in the order presented, in a different order or simultaneously. Further, in some embodiments, some actions listed in FIG. 5 may be omitted.
[0032] FIG. 6 represents exemplary insulin and glucose values on GMM in a healthy adult, according to embodiments as disclosed herein.
[0033] FIG. 7 represents exemplary insulin and glucose values on GMM in a pre-diabetic, according to embodiments as disclosed herein.
[0034] FIG. 8 represents exemplary insulin and glucose values on GMM in a type 2 diabetic, according to embodiments as disclosed herein.
[0035] FIG. 9 represents exemplary insulin and glucose values on GMM in a type 1 diabetic, according to embodiments as disclosed herein.
[0036] FIG. 10 represents exemplary insulin and glucose values on GMM in a patient with insulinoma, according to embodiments as disclosed herein.
[0037] FIG. 11 represents exemplary insulin and glucose values on GMM in prolonged fasting status, according to embodiments as disclosed herein.
[0038] For a healthy adult, the values will be in quadrant 5. However, the values will shift towards upper quadrant (quadrant 8) as a person goes into pre diabetic stage. This will be seen as a movement in the centroid of the values positively in both the axes but more so in the Y axis. As shown in figure 7, this movement of the centroid can be captured by connecting the two centroids by a line. The slope of the line (y2-y1/x2-x1) will be positive (with a value of >1) for a person entering the pre diabetic stage from normal stage. This is because of increased insulin resistance. The body tries to compensate it by increasing the levels of insulin so that the blood glucose level is maintained within the normal range. This will be seen as a movement in the centroid of the values positively in both the axes but more so in the Y axis (hence leading to a slope of >1). The slope of the line can be measured and effect of the drug analyzed by the steepness or the gentleness of the slope. For example, a drug (say metformin) which transforms the slope to a gentler slope (with a stabilization of temporal progression) indicates increasing insulin sensitivity. If the values move rapidly in a sustained way, with a positive slope, as shown in the figure 8, the person should be clinically evaluated for pre diabetes. This method can be used to quantify the effect of a drug on insulin sensitivity/resistance. It may also assist to quantify and the glucogenic/glucolytic action of new/existing drugs.
[0039] Beyond a certain point, the body cannot increase the levels of insulin secreted because of destruction of pancreatic beta cells. Hence the patient enters the phase of frank diabetes mellitus where the blood glucose increases as the insulin level drops.
[0040] This will be seen in the plot as movement in the values negatively on the Y-axis while the X-axis values moves positively as shown in Figure 8. Hence the slope of the line (connecting the centroids) will be negative for a person entering diabetic stage from the pre diabetic stage. As explained in the example above, the slope can be used to judge the progression of the disease. The time when the slope of the curve turns from positive to negative, along with the appearance of hyperglycemic values can be taken as the time at which the patient progressed from pre diabetic stage to frank type 2 diabetes.
[0041] The above are merely examples and it may be obvious to a person of ordinary skill in the art to plot GMM for any glucose metabolism disorder.
[0042] Embodiments herein give a better overview of a disease process and its progression and helps monitoring, managing and treating a spectrum of diseases. Embodiments herein also empower the patients by providing specific details and trends with regard to their individual glucose metabolism. Embodiments herein can be useful for medical device, wellness/lifestyle/fitness OEM’s and pharmaceutical companies by providing more value to their customers. Embodiments herein can be used in research activity including clinical trials for monitoring and managing the patients.
[0043] Embodiments herein can be used in therapeutics to see the effect of a drug on insulin sensitivity/resistance. Embodiments herein can also assist to quantify and the glucogenic/glucolytic action of new/existing drugs by assessing the slope of the line and the temporal progression after treatment with a drug.
[0044] Embodiments herein can be used by blood glucose monitors and can be a vital tool for self-monitoring by patients. Embodiments herein can be used to test the null hypothesis of the effect of various medical and non-medical interventions on the disease.
[0045] Embodiments herein may modify the interface for the diabetes management system using a suitable means (such as an app) which can have embodiments herein incorporated for monitoring the efficacy and response of the patient to the insulin dosage.
[0046] Embodiments herein can be used to test the efficacy of the efficacy of various drugs and other lifestyle interventions (diet, exercise, yoga etc) on the progression of disease. For example, an individual can monitor the effect of a diet strategy on his app having the GMM.
[0047] Embodiments herein can be used in lifestyle/wellness/fitness devices/equipments either stand alone or in conjunction with medical devices as mentioned above.
[0048] Embodiments herein can also be used in a closed loop diabetes management system in which insulin therapy is given based on a continuous glucose monitoring device. Use case in Research:
[0049] Embodiments herein can be used as a tool in research on disorders in glucose metabolism. Embodiments herein can be used in research where glucose clamp technique and other similar models like Homeostatic Model Assessment (HOMA) and Quantitative Insulin Sensitivity Check Index (QUICKI) are used.
[0050] Embodiments herein can be used by studies on diabetes mellitus, gestational diabetes, insulinoma and fasting metabolism. Embodiments herein can be used to test the null hypothesis at an individual and/or at a population level.
[0051] Embodiments herein can be used to validate and correlate chemicals that behave as an independent variable for glucose metabolism.
[0052] Embodiments herein can be used by pharma companies during clinical trials and other researchers who want to monitor the efficacy of a new treatment.
[0053] The embodiments disclosed herein can be implemented through at least one software program running on at least one hardware device and performing network management functions to control the network elements. The network elements shown in Figs. 1a, 1b, 1c, 1d and 4 include blocks which can be at least one of a hardware device, or a combination of hardware device and software module.
[0054] The embodiment disclosed herein describes a method and system for mapping the condition and prognosis of glucose metabolism and its abnormalities using a two dimensional graph plot (with blood insulin levels on one axis and blood glucose level on the other axis), which will give a theoretical construct of the full spectrum of glucose metabolism. Therefore, it is understood that the scope of the protection is extended to such a program and in addition to a computer readable means having a message therein, such computer readable storage means contain program code means for implementation of one or more steps of the method, when the program runs on a server or mobile device or any suitable programmable device. The method is implemented in a preferred embodiment through or together with a software program written in e.g. Very high speed integrated circuit Hardware Description Language (VHDL) another programming language, or implemented by one or more VHDL or several software modules being executed on at least one hardware device. The hardware device can be any kind of portable device that can be programmed. The device may also include means which could be e.g. hardware means like e.g. an ASIC, or a combination of hardware and software means, e.g. an ASIC and an FPGA, or at least one microprocessor and at least one memory with software modules located therein. The method embodiments described herein could be implemented partly in hardware and partly in software. Alternatively, the invention may be implemented on different hardware devices, e.g. using a plurality of CPUs.
[0055] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.