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

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.

1 .- 20 . (canceled) 
     
     
         21 . A health-monitoring device comprising:
 a testing device configured to measure a level of one or more analytes in a sample from a user and generate a signal indicative of the level of the one or more analytes in the sample;   a processor comprising a calculator comprising programming to calculate a concentration of the one or more analytes in the sample based on the signal and a correlator comprising an algorithm configured to determine a correlation between the level of the one or more analytes in the sample and a health parameter indicative of the user's health; and   a user interface comprising an input configured to receive information from the user and a display configured to display at least one of the concentration of the one or more analytes in the sample and the health parameter.   
     
     
         22 . The device of  claim 21 , wherein the health parameter comprises an insulin sensitivity factor, a medication dosage, an assessment of metabolic syndrome, a likelihood of the user developing hypoglycemia, a likelihood of the user developing hyperglycemia and a likelihood that the user recently developed hypoglycemia. 
     
     
         23 . The device of  claim 22 , wherein the health parameter comprises the insulin sensitivity factor. 
     
     
         24 . The device of  claim 22 , wherein the medication dosage comprises an insulin dosage. 
     
     
         25 . The device of  claim 21 , wherein the algorithm includes the information from the user to determine the correlation between the level of the one or more analytes in the sample and the health parameter. 
     
     
         26 . The device of  claim 25 , wherein the information from the user comprises one or more of a type of medication dosage, an amount of medication dosage, a type of food consumption, an amount of food consumption, a weight of the user, and a body composition of the user. 
     
     
         27 . The device of  claim 21 , further comprising a data communication port configured to connect the health-monitoring device to a remote site. 
     
     
         28 . The device of  claim 27 , wherein the data communication port is configured to connect the health-monitoring device to the remote site over a network. 
     
     
         29 . The device of  claim 27 , wherein the data communication port is configured to provide a wireless connection between the health-monitoring device and the remote site. 
     
     
         30 . The device of  claim 29 , wherein the wireless connection comprises an acoustic connection, an optic connection or a radio wave connection. 
     
     
         31 . The device of  claim 30 , wherein the optic connection comprises an infrared connection. 
     
     
         32 . The device of  claim 21 , wherein the testing device is configured to measure the level of a glucose analyte in the sample. 
     
     
         33 . The device of  claim 32 , wherein the glucose analyte comprises glucose, pyruvate, glucose-6-phosphate or lactate. 
     
     
         34 . The device of  claim 21 , wherein the testing device is configured to measure the level of a fat analyte in the sample. 
     
     
         35 . The device of  claim 34 , wherein the fat analyte comprises a ketone, a free fatty acid, glycerol or an analyte indicative of lipolysis in the body. 
     
     
         36 . The device of  claim 21 , wherein the testing device is configured to measure the level of a glucose analyte in the sample and the level of a fat analyte in the sample. 
     
     
         37 . The device of  claim 36 , wherein the glucose analyte comprises glucose and the fat analyte comprises a ketone. 
     
     
         38 . The device of  claim 21 , wherein the sample comprises blood, a derivative of blood, interstitial fluid, urine, a breath sample or saliva. 
     
     
         39 . The device of  claim 21 , wherein the testing device comprises one or more of a photometric, a reflectometric, an electrochemical, a fluorescence and a magnetic based system for measuring the level of the one or more analytes in the sample. 
     
     
         40 . The device of  claim 21 , wherein the testing device comprises a test strip or a skin inserted device. 
     
     
         41 . The device of  claim 21 , wherein the testing device comprises a device which utilizes a non-invasive method of measurement. 
     
     
         42 . A method for monitoring the health of a user, the method comprising:
 measuring, using a testing device, a level of one or more analytes in a sample from a user;   generating, using the testing device, a signal indicative of the level of the one or more analytes in the sample;   calculating, using a processor, a concentration of the one or more analytes in the sample based on the signal;   determining, using the processor, a correlation between the level of the one or more analytes in the sample and a health parameter indicative of the user's health;   receiving information from the user through a user interface; and   displaying on a display at least one of the concentration of the one or more analytes in the sample and the health parameter.   
     
     
         43 . The method of  claim 42 , wherein the health parameter comprises an insulin sensitivity factor, a medication dosage, an assessment of metabolic syndrome, a likelihood of the user developing hypoglycemia, a likelihood of the user developing hyperglycemia and a likelihood that the user recently developed hypoglycemia. 
     
     
         44 . The method of  claim 43 , wherein the health parameter comprises the insulin sensitivity factor. 
     
     
         45 . The method of  claim 43 , wherein the medication dosage comprises an insulin dosage. 
     
     
         46 . The method of  claim 42 , wherein the determining includes using the information from the user to determine the correlation between the level of the one or more analytes in the sample and the health parameter. 
     
     
         47 . The method of  claim 46 , wherein the information from the user comprises one or more of a type of medication dosage, an amount of medication dosage, a type of food consumption, an amount of food consumption, a weight of the user, and a body composition of the user. 
     
     
         48 . The method of  claim 42 , further comprising communicating data between the health-monitoring device and a remote site. 
     
     
         49 . The method of  claim 48 , further comprising storing the data in a database at the remote site. 
     
     
         50 . The method of  claim 48 , wherein the data comprises at least one of the concentration of the one or more analytes in the sample, the information from the user and the health parameter. 
     
     
         51 . The method of  claim 48 , wherein the communicating comprises communicating the data between the health-monitoring device and the remote site over a network. 
     
     
         52 . The method of  claim 48 , wherein the communicating comprises wirelessly communicating the data between the health-monitoring device and the remote site. 
     
     
         53 . The method of  claim 52 , wherein the wirelessly communicating comprises wirelessly communicating over an acoustic connection, an optic connection or a radio wave connection. 
     
     
         54 . The method of  claim 53 , wherein the optic connection comprises an infrared connection. 
     
     
         55 . The method of  claim 42 , wherein the one or more analytes in the sample comprises a glucose analyte. 
     
     
         56 . The method of  claim 55 , wherein the glucose analyte comprises glucose, pyruvate, glucose-6-phosphate or lactate. 
     
     
         57 . The method of  claim 42 , wherein the one or more analytes in the sample comprises a fat analyte. 
     
     
         58 . The method of  claim 57 , wherein the fat analyte comprises a ketone, a free fatty acid, glycerol or an analyte indicative of lipolysis in the body. 
     
     
         59 . The method of  claim 42 , wherein the one or more analytes in the sample comprises a glucose analyte and a fat analyte. 
     
     
         60 . The method of  claim 59 , wherein the glucose analyte comprises glucose and the fat analyte comprises a ketone. 
     
     
         61 . The method of  claim 42 , wherein the displaying comprises displaying at least one of the concentration of the one or more analytes in the sample and the health parameter as a graph. 
     
     
         62 . The method of  claim 42 , wherein the sample comprises blood, a derivative of blood, interstitial fluid, urine, a breath sample or saliva. 
     
     
         63 . The method of  claim 42 , wherein the measuring comprises measuring the level of the one or more analytes in the sample using one or more of a photometric, a reflectometric, an electrochemical, a fluorescence and a magnetic based testing device. 
     
     
         64 . The method of  claim 42 , wherein the measuring comprises measuring the level of the one or more analytes in the sample using a test strip or a skin inserted device. 
     
     
         65 . The method of  claim 42 , wherein the measuring comprises measuring the level of the one or more analytes in the sample using a device which utilizes a non-invasive method of measurement. 
     
     
         66 . A health monitoring system comprising:
 a health-monitoring device comprising:
 a testing device configured to measure a level of one or more analytes in a sample from a user and generate a signal indicative of the level of the one or more analytes in the sample; 
 a processor comprising a calculator comprising programming to calculate a concentration of the one or more analytes in the sample based on the signal and a correlator comprising an algorithm configured to determine a correlation between the level of the one or more analytes in the sample and a health parameter indicative of the user's health; 
 a user interface comprising an input configured to receive information from the user and a display configured to display at least one of the concentration of the one or more analytes in the sample and the health parameter; and 
 a first data communication port; and 
   a remote site comprising a second data communication port,   wherein the first data communication port and the second data communication port are configured to communicate data between the health-monitoring device and the remote site.   
     
     
         67 . The system of  claim 66 , wherein the data comprises at least one of the concentration of the one or more analytes in the sample, the information from the user and the health parameter. 
     
     
         68 . The system of  claim 66 , wherein the first data communication port and the second data communication port are configured to connect the health-monitoring device to the remote site over a network. 
     
     
         69 . The system of  claim 66 , wherein the first data communication port and the second data communication port are configured to provide a wireless connection between the health-monitoring device and the remote site. 
     
     
         70 . The system of  claim 69 , wherein the wireless connection comprises an acoustic connection, an optic connection or a radio wave connection. 
     
     
         71 . The system of  claim 70 , wherein the optic connection comprises an infrared connection. 
     
     
         72 . The system of  claim 66 , wherein the health parameter comprises an insulin sensitivity factor, a medication dosage, an assessment of metabolic syndrome, a likelihood of the user developing hypoglycemia, a likelihood of the user developing hyperglycemia and a likelihood that the user recently developed hypoglycemia. 
     
     
         73 . The system of  claim 72 , wherein the health parameter comprises the insulin sensitivity factor. 
     
     
         74 . The system of  claim 72 , wherein the medication dosage comprises an insulin dosage. 
     
     
         75 . The system of  claim 66 , wherein the algorithm includes the information from the user to determine the correlation between the level of the one or more analytes in the sample and the health parameter. 
     
     
         76 . The system of  claim 66 , wherein the information from the user comprises one or more of a type of medication dosage, an amount of medication dosage, a type of food consumption, an amount of food consumption, a weight of the user, and a body composition of the user. 
     
     
         77 . The system of  claim 66 , wherein the testing device is configured to measure the level of a glucose analyte in the sample. 
     
     
         78 . The system of  claim 77 , wherein the glucose analyte comprises glucose, pyruvate, glucose-6-phosphate or lactate. 
     
     
         79 . The system of  claim 66 , wherein the testing device is configured to measure the level of a fat analyte in the sample. 
     
     
         80 . The system of  claim 79 , wherein the fat analyte comprises a ketone, a free fatty acid, glycerol or an analyte indicative of lipolysis in the body. 
     
     
         81 . The system of  claim 66 , wherein the testing device is configured to measure the level of a glucose analyte in the sample and the level of a fat analyte in the sample. 
     
     
         82 . The system of  claim 81 , wherein the glucose analyte comprises glucose and the fat analyte comprises a ketone. 
     
     
         83 . The system of  claim 66 , wherein the sample comprises blood, a derivative of blood, interstitial fluid, urine, a breath sample or saliva. 
     
     
         84 . The system of  claim 66 , wherein the testing device comprises one or more of a photometric, a reflectometric, an electrochemical, a fluorescence and a magnetic based system for measuring the level of the one or more analytes in the sample. 
     
     
         85 . The system of  claim 66 , wherein the testing device comprises a test strip or a skin inserted device. 
     
     
         86 . The system of  claim 66 , wherein the testing device comprises a device which utilizes a non-invasive method of measurement. 
     
     
         87 . A program executable by a processor of a health monitoring system, the program comprising instructions for operating the system to perform the steps of:
 measuring, using a testing device, a level of one or more analytes in a sample from a user;   generating, using the testing device, a signal indicative of the level of the one or more analytes in the sample;   calculating, using the processor, a concentration of the one or more analytes in the sample based on the signal;   determining, using the processor, a correlation between the level of the one or more analytes in the sample and a health parameter indicative of the user's health;   receiving information from the user through a user interface; and   displaying on a display at least one of the concentration of the one or more analytes in the sample and the health parameter.   
     
     
         88 . The program of  claim 87 , wherein the health parameter comprises an insulin sensitivity factor, a medication dosage, an assessment of metabolic syndrome, a likelihood of the user developing hypoglycemia, a likelihood of the user developing hyperglycemia and a likelihood that the user recently developed hypoglycemia. 
     
     
         89 . The program of  claim 88 , wherein the health parameter comprises the insulin sensitivity factor. 
     
     
         90 . The program of  claim 88 , wherein the medication dosage comprises an insulin dosage. 
     
     
         91 . The program of  claim 87 , wherein the instructions for determining the correlation between the level of the one or more analytes in the sample and the health parameter include using the information from the user to determine the correlation between the level of the one or more analytes in the sample and the health parameter. 
     
     
         92 . The program of  claim 91 , wherein the information from the user comprises one or more of a type of medication dosage, an amount of medication dosage, a type of food consumption, an amount of food consumption, a weight of the user, and a body composition of the user. 
     
     
         93 . The program of  claim 87 , wherein the program further comprises instructions for communicating data between the health-monitoring device and a remote site. 
     
     
         94 . The program of  claim 93 , wherein the program further comprises instructions for storing data in a database at the remote site. 
     
     
         95 . The program of  claim 93 , wherein the data comprises at least one of the concentration of the one or more analytes in the sample, the information from the user and the health parameter. 
     
     
         96 . The program of  claim 93 , wherein the data comprises at least one of the concentration of the one or more analytes in the sample, the information from the user and the health parameter. 
     
     
         97 . The program of  claim 93 , wherein the communicating comprises communicating the data between the health-monitoring device and the remote site over a network. 
     
     
         98 . The program of  claim 93 , wherein the communicating comprises wirelessly communicating the data between the health-monitoring device and the remote site. 
     
     
         99 . The program of  claim 98 , wherein the wirelessly communicating comprises wirelessly communicating over an acoustic connection, an optic connection or a radio wave connection. 
     
     
         100 . The program of  claim 98 , wherein the optic connection comprises an infrared connection. 
     
     
         101 . The program of  claim 87 , wherein the one or more analytes in the sample comprise a glucose analyte. 
     
     
         102 . The program of  claim 100 , wherein the glucose analyte comprises glucose, pyruvate, glucose-6-phosphate or lactate. 
     
     
         103 . The program of  claim 87 , wherein the one or more analytes in the sample comprises a fat analyte. 
     
     
         104 . The program of  claim 103 , wherein the fat analyte comprises a ketone, a free fatty acid, glycerol or an analyte indicative of lipolysis in the body. 
     
     
         105 . The program of  claim 87 , wherein the one or more analytes in the sample comprises a glucose analyte and a fat analyte. 
     
     
         106 . The program of  claim 105 , wherein the glucose analyte comprises glucose and the fat analyte comprises a ketone. 
     
     
         107 . The program of  claim 87 , wherein the program comprises instructions for displaying at least one of the concentration of the one or more analytes in the sample and the health parameter as a graph. 
     
     
         108 . The program of  claim 87 , wherein the sample comprises blood, a derivative of blood, interstitial fluid, urine, a breath sample or saliva. 
     
     
         109 . The program of  claim 87 , wherein the measuring comprises measuring the level of the one or more analytes in the sample using one or more of a photometric, a reflectometric, an electrochemical, a fluorescence and a magnetic based testing device. 
     
     
         110 . The program of  claim 87 , wherein the measuring comprises measuring the level of the one or more analytes in the sample using a test strip or a skin inserted device. 
     
     
         111 . The program of  claim 87 , wherein the measuring comprises measuring the level of the one or more analytes in the sample using a device which utilizes a non-invasive method of measurement.