System and method for determining risk of diabetes based on biochemical marker analysis

Abstract

A method for predicting risk of gestational diabetes mellitus (GDM) in a pregnant individual includes measuring one or more biochemical markers in a blood sample obtained from the pregnant individual to determine one or more biomarker levels, where the one or more measured biochemical markers includes at least one of PAI-2 and sTNFR1, identifying, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level, and, responsive to the identifying, determining a prediction corresponding to a relative risk of the pregnant individual having or developing GDM.

What is claimed: 
     
         1 . A method for predicting risk of gestational diabetes mellitus (GDM) in a pregnant individual, the method comprising:
 measuring one or more biochemical markers in a blood sample obtained from the pregnant individual to determine one or more biomarker levels, wherein the one or more measured biochemical markers comprises at least one of PAI-2 and sTNFR1;   identifying, by a processor of a computing device, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level; and   responsive to the identifying, determining, by the processor, a prediction corresponding to a relative risk of the pregnant individual having or developing GDM.   
     
     
         2 . The method of  claim 1 , wherein the pregnant individual has not been previously diagnosed as diabetic. 
     
     
         3 . The method of  claim 1  or  2 , wherein the difference comprises at least one of a threshold value and a percentage difference. 
     
     
         4 . The method of any of the preceding claims, wherein the prediction is based in part upon at least one maternal history factor of the pregnant individual. 
     
     
         5 . The method of  claim 4 , wherein the at least one maternal history factor comprises one of a gestational age, a weight, a BMI, a family history status, a race, and a smoking status. 
     
     
         6 . The method of any one of the preceding claims, wherein the one or more measured biomarkers comprises PAI-2, and the identifying step comprises identifying, by the processor of the computing device, whether the measured PAI-2 level differs by at least a corresponding threshold amount from a predetermined control PAI-2 level. 
     
     
         7 . The method of any one of the preceding claims, wherein the one or more measured biomarkers comprises PAI-2, and the identifying step comprises identifying, by the processor of the computing device, whether a score based at least in part on the measured PAI-2 level is indicative of the risk of the pregnant individual having or developing GDM. 
     
     
         8 . The method of any one of the preceding claims, wherein the one or more measured biomarkers comprises sTNFR1, and the identifying step comprises identifying, by the processor of the computing device, whether the measured sTNFR1 level differs by at least a corresponding threshold amount from a predetermined control sTNFR1 level. 
     
     
         9 . The method of any one of the preceding claims, wherein the one or more measured biomarkers comprises sTNFR1, and the identifying step comprises identifying, by the processor of the computing device, whether a score based at least in part on the measured sTNFR1 level is indicative of the risk of the pregnant individual having or developing GDM. 
     
     
         10 . The method of any one of the preceding claims, wherein the one or more measured biomarkers comprises PAI-2 and sTNFR1, and the identifying step comprises:
 identifying, by the processor of the computing device, at least one of (i) to (iii):
 (i) whether the measured PAI-2 level differs by at least a corresponding threshold amount from a predetermined control PAI-2 level; 
 (ii) whether the measured sTNFR1 level differs by at least a corresponding threshold amount from a predetermined control sTNFR1 level; and 
 (iii) whether a score based on at least the measured PAI-2 level and the sTNFR1 level is indicative of the risk of the pregnant individual having or developing GDM. 
   
     
     
         11 . The method of any one of the preceding claims, wherein determining the prediction comprises calculating a risk assessment score. 
     
     
         12 . The method of  claim 11 , wherein the risk assessment score comprises a proportional risk value. 
     
     
         13 . The method of  claim 11 , wherein the risk assessment score comprises a numeric risk score assigned on a scale. 
     
     
         14 . The method of claim any of the preceding claims, wherein a first biomarker of the one or more measured biomarkers is PAI-2, and the prediction is positive based at least in part upon identifying a PAI-2 level reflects a statistically significant decrease in comparison to a respective control level. 
     
     
         15 . The method of any of the preceding claims, wherein a first biomarker of the one or more measured biomarkers is sTNFR1, and the prediction is positive based at least in part upon identifying an sTNFR1 level reflects a statistically significant increase in comparison to a respective control level. 
     
     
         16 . The method of any one of the preceding claims, wherein the pregnant individual is within a first trimester stage of pregnancy at time of obtaining the blood sample. 
     
     
         17 . The method of  claim 16 , wherein the first trimester stage ranges from forty-two days from conception to ninety-seven days from conception. 
     
     
         18 . The method of any one of the preceding claims, wherein the blood sample comprises one of a plasma sample and a serum sample. 
     
     
         19 . The method of any one of the preceding claims, wherein measuring the one or more biochemical markers comprises performing an immunoassay. 
     
     
         20 . The method any of the preceding claims, wherein measuring the one or more biochemical markers comprises applying mass spectrometry analysis. 
     
     
         21 . The method of any one of the preceding claims, wherein measuring the one or more biochemical markers comprises determining a concentration of each respective biochemical marker. 
     
     
         22 . The method of any one of the preceding claims, wherein measuring the one or more biochemical markers comprises determining a quantity of each respective biochemical marker. 
     
     
         23 . A system for predicting risk of gestational diabetes mellitus (GDM) in a pregnant individual comprising:
 an in vitro diagnostics kit comprising testing instruments for testing a blood sample obtained from the pregnant individual for one or more biochemical markers, wherein the one or more biochemical markers comprises at least one of PAI-2 and sTNFR1; and   a non-transitory computer-readable medium having instructions stored thereon, wherein the instructions, when executed by a processor, cause the processor to:
 retrieve one or more biomarker levels, wherein each biomarker level of the one or more biomarker levels corresponds to a biochemical marker tested for using the in vitro diagnostics kit, and wherein the retrieved one or more biomarker levels comprises a biomarker level for at least one of PAI-2 and sTNFR1, and 
 calculate a risk assessment score corresponding to a relative risk of the pregnant individual having or developing GDM, wherein the risk assessment score is based in part upon a comparison of the biomarker level and a corresponding predetermined control level. 
   
     
     
         24 . The system of  claim 23 , wherein the instructions cause the processor to, prior to calculating the risk assessment score, access at least one maternal history factor of the pregnant individual. 
     
     
         25 . The system of  claim 24 , wherein accessing the at least one maternal history factor of the pregnant individual comprises causing presentation of a graphical user interface at a display device, wherein the graphical user interface comprises one or more input fields for submitting maternal history factor information regarding the pregnant individual. 
     
     
         26 . The system of  claim 24  or  25 , wherein accessing the at least one maternal history factor of the pregnant individual comprises importing, from an electronic medical record, the at least one maternal history factor. 
     
     
         27 . The system of any one of  claims 23  to  26 , wherein the instructions cause the processor to, after calculating the risk assessment score, cause presentation of the risk assessment score at a display device. 
     
     
         28 . The system of  claim 27 , wherein causing presentation of the risk assessment score comprises causing presentation of risk assessment information. 
     
     
         29 . The system of any of  claims 23  to  28 , wherein the testing instruments comprise at least one of an anti-PAI-2 antibody and an anti-sTNFR1 antibody. 
     
     
         30 . The system of any of  claims 23  to  29 , wherein the testing instruments comprise one or more of an assay buffer, a coated plate, a tracer, and calibrators. 
     
     
         31 . A method for predicting risk of gestational diabetes mellitus (GDM) in a pregnant individual, the method comprising:
 measuring one or more biochemical markers in a blood sample obtained from the pregnant individual to determine one or more biomarker levels, wherein the one or more measured biochemical markers comprises at least one of PAI-2 and sTNFR1; and   calculating, by the processor, a risk assessment score corresponding to a relative risk of the pregnant individual having or developing GDM, wherein the risk assessment score is based in part upon a comparison of the biomarker level and a corresponding predetermined control level.   
     
     
         32 . The method of  claim 31 , wherein measuring the one or more biochemical markers comprises applying mass spectrometry analysis. 
     
     
         33 . The method of  claim 31  or  32 , wherein measuring the one or more biochemical markers comprises performing an immunoassay. 
     
     
         34 . The method of any of  claims 31  to  33 , wherein calculating the risk assessment score comprises normalizing the comparison of the biomarker level and the corresponding predetermined control level based upon one or more maternal demographic values. 
     
     
         35 . The method of  claim 34 , wherein normalizing the comparison comprises applying a multiple of mean statistical analysis. 
     
     
         36 . The method of any of  claims 31  through  35 , wherein calculating the risk assessment score comprises normalizing the comparison of the biomarker level and the corresponding predetermined control level based upon one or more maternal biophysical attributes. 
     
     
         37 . A non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a processor, cause the processor to:
 access measurements of one or more biochemical markers, wherein
 the measurements were obtained by testing biochemical marker levels in a blood sample obtained from a pregnant individual, and 
 the one or more measured biochemical markers comprises at least one of PAI-2 and sTNFR1; and 
   calculate a risk assessment score corresponding to a relative risk of the pregnant individual having or developing gestational diabetes mellitus (GDM), wherein the risk assessment score is based in part upon a comparison of the biomarker level and a corresponding predetermined control level.   
     
     
         38 . A system for predicting risk of gestational diabetes mellitus (GDM) in a pregnant individual comprising:
 an in vitro diagnostics kit comprising testing instruments for testing a blood sample obtained from the pregnant individual for one or more biochemical markers, wherein the one or more biochemical markers comprises at least one of PAI-2 and sTNFR1; and   a non-transitory computer-readable medium having instructions stored thereon, wherein the instructions, when executed by a processor, cause the processor to:
 retrieve one or more biomarker levels, wherein each biomarker level of the one or more biomarker levels corresponds to a biochemical marker tested for using the in vitro diagnostics kit, and wherein the retrieved one or more biomarker levels comprises a biomarker level for at least one of PAI-2 and sTNFR1, and 
 identify, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level; and 
 responsive to the identifying, determine a prediction corresponding to a relative risk of the pregnant individual having or developing GDM. 
   
     
     
         39 . A non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a processor, cause the processor to:
 access measurements of one or more biochemical markers, wherein
 the measurements were obtained by testing biochemical marker levels in a blood sample obtained from a pregnant individual, and 
 the one or more measured biochemical markers comprises at least one of PAI-2 and sTNFR1; 
   identify, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level; and   responsive to the identifying, determine a prediction corresponding to a relative risk of the pregnant individual having or developing GDM.   
     
     
         40 . A method for predicting risk of Type 2 diabetes in an individual, the method comprising:
 measuring one or more biochemical markers in a blood sample obtained from the individual to determine one or more biomarker levels, wherein the one or more measured biochemical markers comprises at least one of PAI-2 and sTNFR1; and   calculating, by a processor of a computing device, a risk assessment score corresponding to a relative risk of the individual having or developing Type 2 diabetes, wherein the risk assessment score is based in part upon a comparison of the biomarker level and a corresponding predetermined control level.   
     
     
         41 . A method for predicting risk of Type 2 diabetes in an individual, the method comprising:
 measuring one or more biochemical markers in a blood sample obtained from the individual to determine one or more biomarker levels, wherein the one or more measured biochemical markers comprises at least one of PAI-2 and sTNFR1;   identifying, by a processor of a computing device, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level; and   responsive to the identifying, determining, by the processor, a prediction corresponding to a relative risk of the individual having or developing Type 2 diabetes.