Control® AST Glucometer kit

Glucometer with 25 Test Strips FREE

01 Glucometer comes with,

  • FREE 25 Test Strips
  • FREE 10 Lancets (needles)
  • 01 Lancing device
  • Check Strip
  • Control Solution vial
  • User Guide (English/Sinhala and Tamil)
  • Log Book
  • User Manual and Warranty Card

Special features

  • Easy to use
  • most accurate and consistent
  • needs a tiny drop of blood (1 μL) – means less pain
  • fast results (in just 5 seconds)
  • 250 test memory
  • 7-90 days averaging
  • 10 – 600 result range
  • Battery life – 5000 tests
  • Auto shut off in 3 minutes
  • Alternate site testing (AST)
  • Bio-sensor Technology (provides very accurate results)
  • Capillary action ( automatically draws blood into the strip)
  • Sample type : capillary whole blood
  • LIFE TIME WARRANTY
  • Supplier – US Diagnostics Inc. in New York, USA.
  • Brand – Control AST
  • Weight – 55g
  • Price – 3150 LKR

 

How to test your blood glucose

Before testing your blood glucose, you will need to code your Control® Meter. The code number on the meter must match the code number on the test strip vial. Insert a new Control® test strip into the test strip port of the Control® meter. The meter will automatically power on and the code will appear. Confirm the code on the meter is the same as on the test strip vial. If the code numbers are different, you will need to change the code on the meter to ensure they match. Press the S button to change the code until the number on the meter matches the one on the test strip vial. Once you have selected the correct number, press the M button. The test strip symbol will blink and now you are ready to test.

 

Place the end of the lancing device against your finger and draw blood.

 

Please the blood from your finger to the tip of the Control® test strip. The test strip will automatically draw the blood.

 

The meter will count down from 5 to 1 on the display. After 5 seconds, the meter will beep and your test result will be displayed on the screen.

 

Remove the test strip and discard.

 

Clinical Accuracy Testing Data

The accuracy of the CONTROL® System was assessed by comparing blood glucose results obtained by patients with those obtained using the Hitachi Glucose Autoanalyzer 747, a laboratory instrument. Glucose levels were measured on 68 and 425 fresh capillary blood specimens by 104 diabetic patients and three healthcare professionals at three different clinical centers.

A fine and direct correlation between Hitachi 747 and CONTROL® were confirmed in the 410 blood samples with the correlation coefficient R=0.9797 and the 104 patients with the correlation coefficient R=0.9782 (Fig. 1 and Fig. 2 respectively). The results indicate that the use of the CONTROL® System generates similar results as the Hitatchi Glucose Autoanalyzer, a laboratory instrument used in hospitals to test for glucose concentration. It also suggests that the fine correlation between the two devices lie within the accuracy standards of the NCCLS.

Figure 1: Linear regression of the 410 blood glucose samples with the Hitachi 747 Vs. CONTROL®
System at the Clinical Centers.

Obtained by Healthcare Professionals in Clinical Centers

Slope: 0.9865
y-intercept: 0.8342
Correlation coefficient(r): 0.9797
No. of samples: 410
Range tested: 68-425mg/dL

Figure 2: Linear regression of the 104 diabetic patients – Hitachi 747 Vs. CONTROL® System

Obtained by Lay diabetics

Slope: 0.9974
y-intercept: -0.2309
Correlation coefficient(r): 0.9782
No. of samples: 104
Range tested: 85-430mg/dL

The study done by the Clinical centers resulted in 100% of the tested specimens, in region marked A, had glucose values that deviated from the reference method of less than 20% or are less than 70 mg/dL by both methods. As a result, the error grid indicates an excellent accuracy standard in obtaining the concentration of glucose with the CONTROL® System. (Fig. 3 & Table 1)

Figure 3: Error Grid Analysis – Hitachi 747 Vs. CONTROL®

Obtained by Healthcare Professionals in Clinical Centers

Table 8: Summary of Error Grid Analysis Results

Zone

Number

%

A

408

100

B

2

0

C

0

D

0

E

0

Total

410

100

Zone A = clinically accurate, leading to correct treatment decisions

Zone B = deviation from the reference by more than 20%, leading to benign or no treatment.

Zone C = over-correcting of acceptable blood glucose levels.

Zone D = represent a potentially dangerous failure to detect and treat glucose levels outside the desired target range.

Zone E = represents results that would lead to an erroneous treatment.

The study done with the lay diabetics resulted in 99% of the tested subjects, in region marked A, had glucose values that deviated from the reference method of less than 20% or are less than 70 mg/dL mg/dL by both methods. As a result, the error grid indicates an excellent accuracy standard in obtaining
the concentration of glucose with the CONTROL® System. (Fig. 4 & Table 2).

Figure 4: Error Grid Analysis – Hitachi 747 Vs. CONTROL®

Obtained by Lay Diabetics


Table 9: Summary of Error Grid Analysis Results

Zone

Number

%

A

103

99

B

1

1

C

0

D

0

E

0

Total

104

100

Zone A = clinically accurate, leading to correct treatment decisions

Zone B = deviation from the reference by more than 20%, leading to benign or no treatment.

Zone C = over-correcting of acceptable blood glucose levels.

Zone D = represent a potentially dangerous failure to detect and treat glucose levels outside the desired target range.

Zone E = represents results that would lead to an erroneous treatment.

In conclusion, it suggests that the accuracy shows a fine correlation between Hitachi 747 and the CONTROL® System with the correlation of R = 0.9797. As a result, the data shown indicates that the results like within the accuracy standard of NCCLS.