Method and apparatus for rapid measurement of HbA1c
AssigneeCME Telemetrix Inc.
InventorsJames Samsoondar, Romuald Pawluczyk, Petersen Borge, Theordore E. Cadell, Bernard Zinman, Bronislaw Bednarz
Life of this patent
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Abstract
Described is a method and apparatus for determining a diabetic patient's compliance with their insulin dosing regime. The method and apparatus involves taking a blood sample from a patient by a routine finger prick and placing it in a special sample tab which is placed in a spectrophotometer sample housing. The spectrophotometer measures Hb and HbA1c concentrations and allows for calculating a ratio of HbA1c to Hb which is indicative of the degree of patient compliance.
Claims27
A method of determining a diabetic patient's compliance with their insulin dosing regime comprising:
- (i) obtaining an untreated blood specimen from said patient;
- (ii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
- (iii) using a calibration algorithm for each of said HbA1c and total Hb to calculate a concentration of each of said HbA1c and total Hb in said specimen from said absorbances measured in step (ii);
- and
- (iv) determining a ratio between the concentrations of HbA1c and total Hb,
- wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of patient compliance.
A method of determining a diabetic patient's compliance with their insulin dosing regime comprising:
- (i) generating a calibration algorithm for each of HbA1c and total Hb;
- (ii) obtaining an untreated blood specimen from said patient;
- (iii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
- (iv) using said calibration algorithms generated in step (i) to calculate a concentration of each of said HbA1c and total Hb in said specimen from said absorbances measured in step (iii);
- and
- (v) determining a ratio between the concentrations of HbA1c and total Hb,
- wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of patient compliance.
- 6.The method of claim 5, wherein said step of using (step iv), includes a step for calculating a first derivative of at least two portions of a spectrum generated from an absorbance scan for each of HbA1c and total Hb.
A method of assessing the control of diabetes in a patient comprising:
- (i) obtaining an untreated blood specimen from said patient;
- (ii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
- (iii) using a calibration algorithm for each of said HbA1c and total Hb to calculate a concentration of each of said HbA1c and total Hb in said specimen from said absorbances measured in step (ii);
- and
- (iv) determining a ratio between the concentrations of HbA1c and total Hb,
- wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of control of diabetes.
A method of assessing the control of diabetes in a patient comprising:
- (i) obtaining an untreated blood specimen from said patient;
- (ii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
- and
- (iii) using a calibration algorithm to calculate a concentration ratio of said HbA1c to total Hb in said specimen from said absorbances measured in step (ii),
- wherein an elevated ratio of HbA1c to total Hb reflects a lack of control of diabetes.
A method of assessing the control of diabetes in a patient comprising:
- (i) generating a calibration algorithm for each of HbA1c and total Hb;
- (ii) obtaining an untreated blood specimen from said patient;
- (iii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
- (iv) using said calibration algorithms generated in step (i) to calculate a concentration of each of said HbA1c and total Hb in said specimen from said absorbances measured in step (iii);
- and
- (v) determining a ratio between the concentrations of HbA1c and total Hb,
- wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of control of diabetes.
A method of assessing the control of diabetes in a patient comprising:
- (i) generating a calibration algorithm for both of HbA1c and total Hb;
- (ii) obtaining an untreated blood specimen from said patient;
- (iii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
- and
- (iv) using said calibration algorithms to calculate a concentration ratio of said HbA1c to total Hb in said specimen from said absorbances measured in step (iii),
- wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of control of diabetes.
Dependencies are inferred from the claim text.