Procedure for verifying the accuracy of non-invasive blood glucose measurement instruments

• US 6,066,847 A
• Filed: 02/01/1994
• Issued: 05/23/2000
• Est. Priority Date: 01/19/1989
• Status: Expired due to Term

• Current Assignee: Futrex, Inc., Harrison Direct Response Enterprises, Inc.
• Original Assignee: Futrex, Inc.
• Inventors: Rosenthal, Robert D.
• Primary Examiner(s): Westin, Edward P.
• Assistant Examiner(s): HANIG, RICHARD E
• Application Number:
  US08/190,227
• Time in Patent Office: 2,303 Days
• Field of Search: 250/341, 250/252.1 R
• US Class Current: 250/252.1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters

Abstract

A procedure for verifying the accuracy of a non-invasive blood glucose measurement instrument utilizes in vitro or invasive measurement instruments, the accuracy of which is independently verifiable. Several glucose readings are taken with each instrument at approximately the same times. The measurement data from the in vitro instrument is transferred to the non-invasive instrument where it is compared to the data regarding the non-invasive measurements. If the difference between the measurements of the respective instruments is within a preset range, the non-invasive instrument is permitted to be used for an additional period of time. However, if the difference is beyond an acceptable limit, then the non-invasive instrument is prevented from taking any additional measurements and must be serviced or repaired.

Claims

1. A procedure for verifying the accuracy of a non-invasive blood glucose measurement instrument, the procedure comprising the steps of:

taking at least one blood glucose measurement using an in vitro type blood glucose measurement instrument by analyzing a drop of the user'"'"'s blood;

taking at least one blood glucose measurement using a non-invasive blood glucose measurement instrument by analyzing a portion of the user'"'"'s body with near-infrared energy;

placing the in vitro type and non-invasive instruments in electrical connection so that data concerning the measurement taken by the in vitro instrument is transferred to the non-invasive instrument;

comparing in the non-invasive instrument the data regarding the measurements taken by each instrument to determine whether the accuracy of the non-invasive instrument is within predetermined limits; and

if the accuracy of the non-invasive instrument is not within said limits, preventing the user from taking any further measurements with the non-invasive instrument.

2. A procedure according to claim 1, wherein the measurement taken by one of the instruments is taken within two minutes of the measurement taken by the other instrument.

3. A procedure according to claim 1, wherein each instrument takes from 3 to 5 measurements which are compared to check the accuracy of the non-invasive instrument.

4. A procedure according to claim 1, wherein the two instruments each have an electrical communications port and are placed in electrical connection before the measurements are taken.

5. A procedure for verifying the accuracy of a blood glucose measurement instrument, the procedure comprising the steps of:

taking from three to five blood glucose measurements of a user with a first measurement instrument, the accuracy of said first instrument being independently verifiable prior to taking any measurements;

taking from three to five blood glucose measurements of said user with a second measurement instrument;

placing the first and second instruments in communication with each other and transferring measurement data from the first instrument to the second instrument and comparing the respective measurement data in the second instrument to determine if the accuracy of the second instrument is within acceptable limits.

6. A procedure for verifying the accuracy of a non-invasive blood glucose measurement instrument, comprising the steps of:

taking a first blood glucose measurement of a user with a measurement instrument whose accuracy has been independently verified;

taking a second blood glucose measurement of said user with said non-invasive measurement instrument; and

comparing said second measurement with said first measurement in order to determine the accuracy of said non-invasive measurement instrument.