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Comparison of Invasive And noninvasive Methods For Measuring Blood Glucose

Precision And Accuracy of noninvasive Measurement of Blood Glucose.

There are Companys out there claiming, to bring the first noninvasive bloodglucose measuring device of the world onto the market.

The first Company however who sold a working noninvasive blood glucose meter  in reality is Biocontrol Inc. Pittsbourgh USA.
Here my report.

I have made this report to find the answer to the following questions :




1. How can the precision of the Diasensor 1000 be determined ?

2. How can the relative accuracy of the Diasensor 1000 be determined ?

3. Which devices have been used for the trial ?

4. In which sequence were the measurements made ?

5. How many measurements have been made ?

6. How do the devices look like, used for measurement and how does the place look like, where the measurements have been made?

7. How precisely are the measurements made with Reflolux S, an usual blood glucose measurement device as used for blood glucose self control from diabetics in Germany.

8. How precisely are the measurements made with HemoCue, a measurement device mainly used in clinics and from  physicians, which was used for the Calibration of the Diasensor 1000 ?

9. How precisely are the measurements made with the Diasensor 1000?

10. Which  relative accuracy exists between the invasive HemoCue Meter and the non-invasive
Diasensor 1000 ?

11. What is the effect of calm paperwork onto the relative accuracy of the HemoCue and the Diasensor 1000?

12. What is the effect of slow movement and 20 minutes sports in the afternoon on a hometrainer onto the relative accuracy of the HemoCue and the Diasensor 1000 ?

13. What is the effect of stress onto the relative accuracy of the Diasensor 1000 and the HemoCue
device ?

14. What is the effect of unusual strong movement, 2 hours of sports on a hometrainer, onto the relative accuracy of the Diasensor 1000 and the HemoCue device ?
 

15. Can the Diasensor 1000 be used to give a warning if the hypoglycaemic blood glucose region is reached ?

and

16. What is the effect of alcoholics to the relative accuracy of the Diasensor 1000 ?

17. For which purpose can the Diasensor 1000 be used ?

18. What causes the declining of the correlation shown under certain circumstances like sports and after stress ?

19. What is the reason why the Diasensor 1000 can not be used to detect or monitor for hypoglycenmie
( low blood sugar) ?

20. Which possibilities exist to solve the problem shown and to improve the relative accuracy of the non-invasive measurement ?

The precision of a measuring instrument can be determined by comparison of paired measurements made by the same device. Ideally, the paired values from the measuring instrument should be the same if the time difference between the two measurements is short and there is no change in the true value of what is being measured.
 



2. How can the relative accuracy of the Diasensor 1000 be determined ?

The relative accuracy of a measuring instrument can be determined by comparison of paired measurements made by two different instruments.
 



3. Which devices have been used for the trial ?

The following devices were used for the comparison testing part 1:

1. Reflolux S - an invasive meter which uses familiar test strips; Boehringer Mannheim Germany.

2. HemoCue - an invasive meter which uses a small cuvette to hold a blood sample; HemoCue AB, Sweden.

3. Diasensor 1000 - Noninvasive Blood Glucose Meter,  Biocontrol Technology, Inc., Diasense, Inc. ; USA



4. In which sequence were the measurements made ?

The question for the sequence in which the measurements were made is important, as for the trial the time difference between two paired measurements should be as short as possible, to achieve that the true value of that what shall be measured, in the example the blood-glucose, changes as less as possible.

Tests with the three meters were performed in the following sequence:
 
 

1. Measurement with Reflolux S

2. Measurement  with HemoCue

3. Measurement with Diasensor 1000

4. Measurement with Diasensor 1000

5. Measurement  with HemoCue

6. Measurement with Reflolux S

Each testing sequence consisted of 6 single measurements. Each sequence took an average of 7 minutes to complete.

5. How many measurements have been made ?
 

The more measurements a trial contains the surer the results are and the more precise the measured value is.

A total of 100 testing sequences were evaluated over a period of more than one month.
 


In order to compare two measured values with each other, one can form a correlation coefficient. This correlation coefficient is obtained by dividing the two values by each other. Ideally, if both values are equal, the number 1.00 is obtained. The further away the correlation coefficient is from 1.00, the greater the difference between the measured values.
 


6. How do the devices look like, used for measurement and how does the place look like, where the measurements have been made?

If the place, where the measurements are made, is free from influences that might desturb the measurements, the values received may be more precisely.

Picture of the devices used for measurement
 



7. How precisely are the measurements made with Reflolux S, an usual blood glucose measurement device as used for blood glucose self control from diabetics in Germany.
 

The Reflolux S in the trial reached a Correlation-Coefficient of 0,915, because of this, the difference of two measurements made in short time one after the other, was in an average 8,5%.



8. How precisely are the measurements made with HemoCue, a measurement device mainly used in clinics and from  physicians, which was used for the Calibration of the Diasensor 1000 ?

The  HemoCue in the trial reached a Correlation-Coefficient of 0,959, because of this, the difference of two measurements made in a short time one after the other, was in an average 4,1%.

This showes, that the HemoCue in the trial, under the same conditions, measures more precisely than the Reflolux S.
 
 



9. How precisely are the measurements made with the Diasensor 1000?

Der The Diasensor 1000 in the trial reached a Correlation-Coefficient of 0,820, bekause of this, the difference of two mearuements mad in a short time one after the other, was in an average 18%.
 

This showes, that the Diasensor 1000 in the trial, under the same conditions, mesures less precisely than the invasive measurement devices.
 





10. Which  relative accuracy exists between the invasive HemoCue meter and the non-invasive
Diasensor 1000 ?

To get the relative accuracy the Correlation-Coefficient for the HemoCue and the Diasensor 1000 was calculated , sit was 0,753.

Thus the difference between invasive an non-invasive measurement method was in an average 24,7%.

To tell it in an example, if the HemoCue measures a bloodglucose value of 100 mg/dl, it may be, that the Diasensor 1000 measures a bloodglucose value of 124,7 mg/dl or 75,3 mg/dl.

It is very important, that the difference showed above is an average difference and that in in single cases the difference may be lower but even much higher.

Because of this a second trial was performed to find out, under which conditions the relative accuracy  of the non-invasive measurement would be low, to find out  at least, what disturbes the non-invasive measurement ?


Part 2

Evaluation of the relative accuracy of the Diasensor 1000 Noninvasve Blood Glucose Monitor in defined situations.

Objective:

Objective of the evaluation  part 2 was, to find out, wether the Diasensor 1000 could be used instead of an invasive blood-glucose meter for intensified diabetes therapy.

Research design and methods:

50 paired measurements every 15 minutes on five days with definded situations were made. Totally 250 paired measurements were made.

The days were: 11. 12. 99;  18. 12. 99;  14.01.00;  22.01.00;  28.01.00.

The Diasensor 1000 was used to get the noninvasive measurement and the HemoCue meter to get the standard measurement.

Correlation coefficients for every single pair and the average correlation of the days were calculated.
A graphic, that shows a bloodglucose dayprofile of the single day was drawn.

Correlation-Coefficents for every single pair of values were calculated and the average correlation of the singele days were calculated. Grafics were drawn to show the bloodglucose-dayprofile of the days listed above.





11.12.99

11. What is the effect of calm paperwork onto the relative accuracy of the HemoCue and the Diasensor 1000?

Situation: As less movement at possible. Paperwork 


Values for the 11. December 1999



Time:    HemoCue:    Diasensor 1000:    Comment:    Correlation:
7:27     3,5                    8,83                5N 6B 4 BE          0,396
7:45     3,7                    11,8                                            0,314
7:59     5,9                    9,08                 Shower                0,605
8:17     9,2                    16,5                                            0,558
8:31     11,9                  10,0                                            0,840
8:44     14,6                  13,0                                            0,890
9:00     16,4                  16,4                  Working while     1,000
9:17     17,8                  18,1                   sitting                 0,983
9:30     18,5                  17,7                                            0,957
9:46     18,1                  20,2                                            0,896


Average correlation of this 10 Values:                                0,748




Time:    HemoCue:    Diasensor 1000:    Comment:      Correlation:
10:00       17,6                    20,2                                        0,871
10:15       16,8                    21,1                                        0,796
10:30       15,8                    18,8                                        0,840
10:44       15,0                    18,6                                        0,806
10:59       14,7                    18,2                                        0,808
11:15       13,3                    20,9                                        0,636
11:30       13,0                    20,3                                        0,640
11:44       12,0                    18,5                                        0,649
12:00       11,3                    15,8                                        0,715
12:15       10,8                    18,5                                        0,584


Average correlation of this 10 values:                                  0,735


Time:    HemoCue:    Diasensor 1000:    Comment:       Correlation:
12:30    10,5                    18,2                                          0,577
12:45    9,8                      18,0                6N                      0,544
12:59    9,2                      14,9                                          0,617
13:15    8,7                      15,5                4BE                    0,561
13:30    9,3                      16,6                                          0,560
13:42    11,1                    14,6                Coffee                 0,760
14:01    12,1                    15,3                10min Movement 0,791
14:16    13,2                    20,2                                           0,653
14:29    12,4                    16,7                                           0,743
14:46    11,5                    14,9                                           0,772


Average correlation of this 10 values:                                  0,658




Time:    HemoCue:    Diasensor 1000:    Comment:      Correlation:
15:01    10,5                  14,6                                         0,719
15:29    8,9                    13,3                                         0,669
15:43    8,7                    17,2                                         0,506
16:00    8,2                    12,8                                         0,641
16:17    6,9                    7,78                                         0,887
16:33    5,8                    8,28                                         0,700
16:46    5,3                    9,28                                         0,571
17:01    5,0                    10,9                                         0,459
17:13    4,9                    12,5                                         0,392
17:31    4,3                     5,45                                        0,789 

Average correlation of this 10 values:                              0,633



Time:    HemoCue:    Diasensor 1000:    Comment:    Correlation:
17:46    3,8                    7,05                                         0,539
18:01    3,3                     9,75                                        0,338
18:16    3,7                     7,85                                        0,471
18:29    3,5                     9,25                                        0,378
18:43    3,4                    10,7                        2BE          0,318
18:59    5,8                     7,27                  5N 3BE          0,798
19:16    9,8                    11,7                                         0,838
19:28    10,7                  11,6                                         0,922
19:45    8,4                    12,7                                         0,661
20:01    8,3                    16,2                                         0,512

Average correlation of this 10 values:                               0,578

Correlation for the  11. December 1999                            0,670




 


 


- Viewing the graphic you see, that the line, showing the movement of bloodglucose measured with the Diasensor 1000, makes much more movements than the line showing the movement of bloodglucose measured with the HemoCue device.
- In the region where the bloodglucose values move up strongly, from 7:27 am to 9:30 am, the line of the bloodglucose values measured with the Diasensor 1000 followes the line of the bloodglucose values measured with the HemoCue quite closely. In this region the values of the Diasensor 1000 are lower than the values of the HemoCue.
- During the following, slowly declining line of the values measured with the HemoCue, the values measured with the Diasensor 1000 are consequently higher than the values of the HemoCue.
- The declinig of the bloodglucose values into the region of 5 mmol/l between 17:30 (5:30 pm) and 19:00
( 7:00 pm) is not detected by the Diasensor 1000.
 





18.12.99

12. What is the effect of slow movement and 20 minutes sports in the afternoon on a hometrainer onto the relative accuracy of the HemoCue and the Diasensor 1000 ?

Situation: Slow movement. 20 minutes sport in the afternoon. 



Values from the 18. December 1999.

Time:    HemoCue:    Diasensor 1000:    Comment:    Correlation:
6:16    12,8                   18,7                5N 6B             0,684
6:32    12,6                   13,5             5min gymnastics  0,933
6:46    13,1                   21,2                  Shower          0,618
7:02    12,4                   18,0              2BE Coffee        0,689
7:16    11,0                   14,9                                       0,738
7:27    10,8                   17,9                                       0,603
7:48    11,6                   14,0                                       0,829
8:02    11,5                   15,1                                       0,762
8:14    11,6                   14,0                                       0,829
8:30    9,7                     17,4                                       0,557 
Average correlation of this 10 values:                            0,724





Time:    HemoCue:    Diasensor 1000:    Comment:    Correlation:
8:47      6,7                   12,5                                        0,536
8:59      4,6                    9,55                                       0,482
9:17      2,4                    11,5               2 BE                 0,209
9:31      2,7                    4,65                3BE                 0,581
9:46      4,8                    5,75                                       0,991
10:01    6,4                    7,65             Movement           0,837
10:15    5,2                    12,1                                       0,430
10:32    4,2                    7,61                                       0,552
10:48    4,7                    8,41                                       0,559
11:02    3,7                    4,41                                       0,839


Average Correlation of this 10 values:                            0,602


Time:    HemoCue:    Diasensor 1000:    Comment:    Correlation:
11:16    3,3                    4,51                   2BE              0,732
11:31    5,1                    9,41                                        0,542
11:46    5,6                    5,91                                        0,948
12:00    5,5                    3,31                                        0,602
12:20    5,0                    6,61                                        0,756
12:32    4,8                    2,81                                        0,585
12:44    4,7                    8,71                                        0,540
13:02    3,9                    3,11                     1BE             0,797
13:15    3,8                    5,31                                         0,716
13:31    7,6                    2,91                                         0,383


Average correlation of this 10 values:                              0,660




Time:    HemoCue:    Diasensor 1000:    Comment:    Correlation:
13:46    11,2                  10,4               Coffee                 0,929
14:02    12,6                  10,2                                          0,810
14:18    12,8                  14,6                                          0,877
14:29    13,7                  12,4                                          0,905
14:47    14,1                  13,3                                          0,943
15:00    12,5                  17,3                10 min sports       0,723
15:15    9,1                    22,8                10 min sports       0,399
15:30    9,0                    15,7                                          0,573
15:46    8,8                    10,4                                          0,846
16:01    8,6                    11,1                                          0,775


Average correlation of this 10 values:                               0,778



Time:    HemoCue:    Diasensor 1000:    Comment:    Correlation:
16:17    7,6                    13,6                                          0,559
16:30    7,6                    8,38                                          0,907
16:43    7,5                    7,86              Coffee; stress        0,954
17:02    8,0                    6,26                                          0,783
17:30    7,2                    6,26                                          0,869
17:48    7,4                    7,16                                          0,968
18:16    7,2                    7,54                                          0,955
18:31    7,3                    8,94                    4N                  0,817
18:46    7,4                    9,94                                          0,744


Average correlation of this 10 values:                               0,822

Values from the 18. December 1999                                0,717






- Viewing the graphic you see, that the line, showing the movement of bloodglucose measured with the Diasensor 1000, makes much more movements than the line showing the movement of bloodglucose measured with the HemoCue device.
-During the declining of the line of values in the region from 6:16 a.m. to 9:17 a:m the values of the Diasensor 1000 are higher than the values of the HemoCue device.
-The Diasensor 1000 does not detect the short hypoglycaemic region of 3 mmol/l at 9:17 a.m.
- in the region from 11:16 a.m. to 3:15 p.m. are sometimes higher and sometimes lower than the values of the HemoCue device.
- at 15:15 p.m., this is the time where 20 minutes Sport has been made, the value of the Diasensor 1000 is much higher than the the value of the HemoCue device.
 



14. January. 2000

13. What is the effect of stress onto the relative accuracy of the Diasensor 1000 and the HemoCue
device ?

Situation:  little movement, no sports, situation after a stressing morning with much work.



Values from the 14. January 2000 

Time:    HemoCue:    Diasensor 1000:    Comments:       Correlation:
13:03    6,4                    10,9                    5N                0,587
13:15    5,3                     9,59                                        0,553
13:29    4,6                     4,34                                        0,954
13:45    3,7                     (lo)4,49                5BE             0,824
14:01    5,5                     3,79                                        0,689
14:19    7,7                     (lo)(lo)4,99                              0,648
14:31    9,0                      3,89                                       0,432
14:46    8,1                      6,69                                       0,825
14:69    7,5                      5,69                                       0,759
15:15    7,2                      3,39                0,5l Water      0,471


Average correlation of this 10 values:                              0,674



Time:    HemoCue:    Diasensor 1000:    Comments:          Correlation:
15:30    6,6                      5,19                                         0,786
15:44    6,1                      (lo) 5,99                                   0,982
16:00    5,8                       6,36                                        0,912
16:14    4,1                       3,29              2 BE                  0,802
16:30    4,6                      (lo)4,39                                    0,954
16:45    5,1                       2,99                                        0,586
17:02    5,0                      (lo)(lo)5,09                               0,982
17:16    5,3                      (lo)(lo)3,99                               0,640
17:33    6,4                      (lo)4,79                                    0,748
17:46    5,3                       3,29                                        0,613

Average correlation of this 10 values:                                 0,805


Time:    HemoCue:    Diasensor 1000:    Comments:           Correlation:
18:01    5,4                      3,99             0,5l Water           0,739
18:15    4,7                      (lo)3,49                                     0,743
18:30    4,3                      (lo)(lo)(lo)    4N 2BE                  0,00
18:45    4,2                      (lo)3,79                                     0,902
19:01    3,9                      (lo)(lo)(lo)        3BE                   0,0
19:17    4,0                      (lo)(lo)4,69                                0,853
19:45    6,2                       3,29                                         0,526
20:00    4,9                       (lo)(lo)6,86                               0,714
20:16    4,4                       4,09                                         0,930

Average correlation of this 10 values:                                  0,541




Time:    HemoCue:    Diasensor 1000:    Comments:            Correlation:
20:29    3,6                      (lo)(lo)(lo)       3BE                    0,0
20:46    3,6                       4,19                                         0,859
21:00    4,2                       6,69                                         0,628
21:16    5,1                       4,99                                         0,978
21:29    6,1                       2,99                                         0,490
21:45    6,8                       (lo)4,89                                    0,719
21:59    6,7                       (lo)3,09                                    0,461
22:15    6,6                       3,39                                         0,514
22:31    7,4                       (lo)3,89                                    0,526
22:45    7,9                       2,99                                         0,378


Average correlation of this 10 values:                                  0,555


Time:    HemoCue:    Diasensor 1000:    Comments:          Correlation:
23:00    7,4                    8,29                                           0,893
23:16    7,6                    7,49                                           0,986
23:30    7,7                    (lo)4,69                                      0,583
23:45    8,3                    9,15                                           0,907
24:00    8,3                    7,09                                           0,854
00:15    9,0                    7,09                                           0,788
00:30    9,2                    6,79                                           0,738
00:45    9,3                    9,99                                           0,921
01:00    9,7                    9,79                                           0,990
01:15    9,4                    4,99                                           0,531

Average correlation of this 10 values:                                0,820


Average correlation of the 14. January.2000  und 15.January 2000             0,679



 



- Viewing the graphic you see, that the line, showing the movement of bloodglucose measured with the Diasensor 1000, makes much more movements than the line showing the movement of bloodglucose measured with the HemoCue device.
- Most values of the Diasensor 1000 in this situation are lower than the values of the HemoCue.
- In the region of 6:15 p.m. ( 18:15) and 8:30 p.m. (20:30) the Diasensor 1000 can not calculate a glucosevalue when even tried three times to get  a glucose value. The Diasensor shows the message " out of range error lo " what means that the device can not show a glucose value, as the value would be to low.




22. January 2000

14. What is the effect of unusual strong movement, 2 hours of sports on a hometrainer, onto the relative accuracy of the Diasensor 1000 and the HemoCue device ?

Two hours of sport on a hometrainer in the morning.



Values from the 22. January 2000

Time:    HemoCue:    Diasensor 1000:    Comment:           Correlation:
06:30    13,4                    16,7              QC 16,2 pass        0,802
06:45    14,0                    19,7               5N6B                  0,711
07:02    13,3                    12,3                                          0,925
07:16    13,8                    16,0                                          0,863
07:30    14,2                    13,7                                          0,965
07:46    14,3                    15,8                                          0,905
08:02    10,8                    14,8                3 BE                   0,730
08:15    16,3                    18,9                10min sports         0,862
08:30    16,2                    24,9                10min sports         0,651
08:44    16,6                    27,6                10min sports         0,601
                                                             0,5 l Water

Average correlation of this 10 values:                                    0,741



Time:    HemoCue:    Diasensor 1000:      Comment:           Correlation:
08:59    12,8                    27,5              10min sports             0,465
09:15    11,2                    26,4              10min sports             0,424
09:29     8,5                     23,8              10min sports             0,336
09:46     6,5                     25,2              10min sports             0,258
10:00     5,0                     24,3              10min sports             0,206
10:02     4,9                     19,8              removed sweat          0,247
                                                           with water from arm
10:08     4,3                     22,5              hold arm in cold         0,191
                                                           water
10:12     4,1                     19,2              trainings end              0,214
10:29     3,1                     14,0              shower 3BE               0,221
10:45     2,8                     6,6                3 BE                         0,424

Average correlation of this 10 values:                                     0,299

Time:    HemoCue:    Diasensor 1000:    Comment:         Correlation:
11:01    3,4                    5,6                                              0,607
11:14    5,1                    4,7                                              0,461
11:30    7,4                    (lo)8,90         short strong             0,831
                                                         movement
11:45    8,5                    5,30                                            0,624
12:00    9,3                    7,70                                            0,828
12:16    10,6                  7,50                                            0,708
12:32    9,5                    6,50                                            0,684
12:46    9,4                    6,00                                            0,638
13:01    8,9                    9,60                                            0,927
13:16    7,5                    4,70                                            0,627

Average correlation of this 10 values:                                  0,694




Time:    HemoCue:    Diasensor 1000:    Comment:       Correlation:
13:34    6,0                    3,40                                            0,567
13:47    5,6                    (lo) 3,70                                      0,661
14:00    5,0                    (lo)(lo)5,40                                  0,926
14:17    4,1                    (lo)(lo)4,50     3N                         0,911
14:29    3,8                    (lo)(lo)(lo)      3BE                        0,0
14:44    4,6                    (lo)(lo)(lo)      3BE                        0,0
15:01    5,5                    (lo)3,9                                          0,355
15:17    6,3                    4,20                                             0,667
15:31    5,7                    4,80                                             0,525
15:46    6,3                    6,20                                             0,984

Average correlation of this 10 values:                                  0,560 





Time:    HemoCue:    Diasensor 1000:    Comment:        Correlation:
16:03    6,3                    4,00                                            0,635
16:32    6,9                    4,60                                            0,667
16:47    7,3                    (lo)6,10                                       0,836
17:04    7,0                    3,70                                            0,529
17:16    7,1                    4,40                                            0,620
17:33    7,7                    2,80                                            0,364
17:46    8,3                    4,80                                            0,578
18:01    8,9                    6,80                                            0,764
18:15    9,2                    3,60                                            0,283
18:30    9,4                    (lo)7,80                                       0,830

Average correlation of this 10 values:                                 0,611 


Average correlation for the 22. January 2000                      0,581


- Viewing the graphic you see, that the line, showing the movement of bloodglucose measured with the Diasensor 1000, makes much more movements than the line showing the movement of bloodglucose measured with the HemoCue device.
-During sports in the region from 8:15 a.m. to 12:12 a.m. a significant difference between the values of the Diasensor 1000 an the values of the HemoCue device is shown. While the values of the HemoCue meter show a constant declining of ghe bloodglucose values, what physiologically was expected, the Diasensor 1000 shows continuously very high bloodglucose levels to nearly 28 mmol/l.
- After the end of training, the line of values from the Diasensor 1000 moves down in a very short time.
The short hypoglycaemic reginon at 10:45 a.m. is not detected by the Diasensor 1000.
-After sports in the region form 11:30 a.m to 6:30 p.m. ( 18:30 )  the values of the HemoCue are mostly higher than the values of the Diasensor 1000.
- In the region from 2:29 p.m. to 2:45 the Diasensor 1000 can not calculate a glucose value when tried three times, but showes the message "out of range error lo " what means that the bloodglucose value would be so lo, that a measurement is not possible.




28. January 2000

15. Can the Diasensor 1000 be used to give a warning if the hypoglycaemic blood glucose region is reached ?

and

16. What is the effect of alcoholics to the relative accuracy of the Diasensor 1000 ?

Situation: light hypoglycaemic episode in the afternoon, after a morning with much stress and work. Effect of 0,5 l red wine in the afternoon.

Values for the 28. January 2000



Time:    HemoCue:    Diasensor 1000:    Comment:        Correlation:
13:15    10,2                    9,7                6N; QC 16,2 pass  0,951
13:32    8,8                      8,0                                            0,909
13:47    8,4                      4,7                4BE                      0,560
14:00    9,8                      3,4                Coffee                   0,347
14:16    8,8                      2,8                                             0,318
14:33    8,8                      3,7                light movement      0,420
14:47    7,6                      5,4                                             0,711
15:02    6,2                      (lo)(lo)3,8                                   0,613
15:17    5,0                      4,0                0,5l Water              0,800
15:30    4,7                      (lo)(lo)4,7                                   0,959

Average correlation of this 10 values:                                   0,659





Time:    HemoCue:    Diasensor 1000:    Comment:           Correlation:
15:45    4,2                    (lo)(lo)3,7        subjektive              0,881
                                                           hypoglycaemie
                                                           detected
16:01    2,8                    (lo)(lo)(lo)        3BE                       0,0
16:18    3,5                    (lo)(lo)(lo)                                      0,0
16:32    5,1                    (lo)(lo)(lo)                                      0,0
16:45    6,3                    (lo)(lo)(lo)                                      0,0
17:02    7,3                    (lo)3,8                                           0,521
17:15    7,9                    (lo)4,2                                           0,532
17:26    7,7                    (lo)3,9                                           0,506
17:46    9,0                    (lo)(lo)3,7                                      0,411
18:02    10,0                  (lo)5,4               throath-pain           0,540

Average correlation of this 10 values:                                   0,339




Time:    HemoCue:    Diasensor 1000:    Comment:        Correlation:
18:17    11,6                    7,4                                             0,638
18:33    12,4                    6,6                          5N               0,532
18:46    13,3                    5,1                                              0,383
19:02    13,1                    7,3                                              0,557
19:16    11,4                    5,4                                              0,474
19:31    8,0                      8,2                        3BE               0,976
19:47    5,9                      2,9                                              0,492
20:01    4,6                      5,9                         1BE               0,780
20:17    5,1                      (lo)(lo)(lo)                                    0,0
20:33    4,8                      (lo)4,7                                         0,979

Average correlation of this 10 values:                                    0,581



Zeit:    HemoCue:    Diasensor 1000:    Correlation:    Korrelation:
20:48    4,9                    3,4                Glas red wine          0,694
21:02    4,0                    4,6                                              0,870
21:15    4,7                    6,8                                              0,691
21:32    4,8                    5,8                                              0,828
21:45    5,2                    3,4                   4B 2,5 BE            0,654
22:00    4,3                    6,0                                              0,717
22:15    5,6                    8,0                                              0,700
22:30    6,3                    4,7                                              0,746
22:51    6,9                    11,2                                            0,616
23:03    6,4                     5,62                                           0,878



Average correlation of this 10 values:                                  0,739


Time:    HemoCue:    Diasensor 1000:    Comment:        Correlation:
23:18    6,2                   6,12                                             0,987
23:32    5,9                   (lo)(lo)3,32                                   0,563
23:45    6,6                   (lo)(lo)(lo)                                     0,0
24:00    6,7                   (lo)4,02                                         0,600
00:15    6,5                   (lo)(lo)(lo)                                     0,0
00:32    6,7                   (lo)(lo)7,32                                    0,915
00:45    7,1                   (lo)5,02                                         0,707
01:01    7,8                   (lo)4,92                                         0,631
01:15    7,4                   (lo)7,72                                         0,959
01:32    6,9                    4,82                                             0,699

Average correlation of this 10 values:                                   0,606 

Average correlation of the 28. January 2000                         0,585



- Viewing the graphic you see, that the line, showing the movement of bloodglucose measured with the Diasensor 1000, makes much more movements than the line showing the movement of bloodglucose measured with the HemoCue device.
- In the region from 01:15 p.m. ( 13:15) to 7:30 p.m ( 19:30 ) the values of the Diasensor 1000 are lower than the bloodglucose values measured by the HemoCue.
- After the short hypoglycaemic episode at 04:16 p.m. ( 16:16 ) the Diasensor 1000 can not calculate a glucose value after trying three times, but shows for one hour the error message: " out of range error lo " what means, that the glucose value could not be measured, as it would be to lo.
- after 0,5 l red wine in the evening, some of the values of the Diasensor 1000 in the time region from 08: 30 p.m. ( 20:30 ) to 11:18 p.m. the values of the Diasensor 1000 are higher than the values of the HemoCue device, after this time they fall below the values of the HemoCue.

- At 11:45 p.m. ( 23:45 ) and 0:15 a.m ( 00:15 ) the Diasensor 1000 can not calculate a glucose value after trying three times, but shows for one hour the error message: " out of range error lo " what means, that the glucose value could not be measured, as it would be to lo.
- Um 23:45 Uhr und um 00:15 Uhr kann der Diasensor 1000 nach dreimaligem erfolglosen Versuch 




17. For which purpose can the Diasensor 1000 be used ?

 11. June 1999; Recommendation of the manufacturer Biocontrol Inc. for the intended use of the Diasensor 1000.

Last update 20. Oktober 1999

Biocontrol Technology recommends that averages of blood glucose test results obtained with the Diasensor 1000 over 2 - 4 weeks be used by physicians together with other infromation to adjust insulin dose.

Individual test results obtained from the Diasensor 1000 are not intended to be used to adjust insulin dose.

The Diasensor 1000 is not intended to be used to detect or monitor for hypoglycemia ( low blood sugar).



On behalf of the private evaluation above, I want to join this recommendation in full.

18. What causes the declining of the correlation shown under certain circumstances like sports and after stress ?

19. What is the reason why the Diasensor 1000 can not be used to detect or monitor for hypoglycenmie
( low blood sugar) ?
 

Hypothesis:

1. During sports the diameter of the tiny bloodvessels, even in the region in which the Diasensor 1000 makes the measurement with infrared light, becomes larger. More blood flows through this region during sports as usual. Because of this the region where the measurement is made contents more blood than usual what causes, that the Diasensor 1000 calculates a larger amount of blood glucose depending on the lager amount of blood in the tissue.

2. After hard work or stress, the diameter of tiny blood vessels even in the region in which the Diasensor 1000 makes the measurement with infrared light becomes smaller. Less blood flows through this region after hard work or stress as usual. Because of this the region where the measurement is made contents less blood than usual what causes, that the Diasensor 1000 calculates a lower blood glucose level depending on the smaller amount of blood in the tissue.

3. If a hypoglycaemia ( episode of low blood sugar ) occurs during sports, the Diasensor can not detect the hypoglycaemia, as the smaller content of sugar in the blood during hypoglycaemia is overwhelmed by the opening of the tiny blood vessels and therefor larger amount of blood in the tissue as usual, which the Diasensor 1000 uses for measurement.

4. If hypoglycaemia  ( episode of low blood sugar ) occurs after hard work or stress, the Diasensor calculates to low blood glucsoe values for one hour after the hypoglycaemia, as the rising of the blood glucose after hypyoglycaemia is overwhelmed by the closing of the tiny blood vessels and therefor less blood in the tissue as usual, which the Diasensor 1000 uses for measurement.




20. Which possibilities exist to solve the problem shown and to improve the relative accuracy of the non-invasive measurement ?
 

Proposal to solve the problem:

To solve the problem, and to improve the relative accuracy of the non-invasive measurement of blood glucoes with infrared technology, I want to porpose to measure one or more additional parameters of the blood as correcting factors, to detect the amount of blood which the tissue contents in the moment where the measurement is made. A correcting factor could be used to modify the algorythm used for calculating the amount of blood glucose dependent of the content of blood in the tissue during measurement
 

As parameter the red color of the blood, haemoglobin, cold be used, or other factors that are found in the blood constantly.  




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