ixensor

PixoTest Glucose

PIXOTEST – EASY & SMART

PixoTest® is the new all-in-one, meter-free blood glucose monitoring system. The innovative colorimetric measurement technology allows the user to carry only a smartphone, a mounting clip and sufficient test units for their daily use. The PixoHealth App assists the user through the measurement process, and the blood glucose readings are available at any time through the app or from the Cloud.

The PixoTest® Glucose Test Strip with Integrated Lancet Cartridge consists of a single use reagent membrane and a sterile, single-use lancet. The PixoTest® Blood Glucose Monitoring test method uses smartphone technology in conjunction with the PixoTest® Glucose to measure blood glucose. The system is able to store and recall measurement records, the capacity of which depends on the memory space available on the user’s smartphone.

Features

  • PixoHealth App
  • Product Specifications
  • Smartphone Compability
  • Clinical Information
  • Certificates
  • Diabetes

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THE PIXOHEALTH APP COMPLETES THE ALL-IN-ONE SYSTEM.

After using your smartphone to measure your blood glucose level, your measurements are directly saved via the PixoHealth app. The app logs readings automatically and provides digital logbooks and charts to review the trends of test results. Using the PixoHealth app allows you to measure, store and monitor your blood glucose level conveniently and quickly.
Measurements with your smartphone

Simply attach the PixoTest ® Unit to your smartphone, launch the app and start measuring your blood glucose levels. Test results will be logged automatically on your smartphone.

 

 

Record

Test results and further information can be reviewed via the digital logbook. The app allows you to tag the time when you took the measurement, e.g., “After breakfast” (After meal), “Before lunch” (Before meal) or “Before bed”.

 

 

Trends

View the trends for specific time periods, including morning, lunch, dinner and before and after meals, for better diabetes management.

 

 

Pie Chart

You can understand how well your blood glucose level is adjusted by reviewing the percentage of Normal, High and Low results.

 

 

Personal account

After a simple registration process, you can view your data through the app or on your personal portal on the iXensor website.

 


  • Measuring Range

    40–500 mg/dL (2.2–27.8 mmol/L). Screen will display “Hi” when the results are above 500 mg/dL, “Lo” when the results are less than 40 mg/dL


  • Hematocrit

    20%-60%


  • Measuring time

    <8 seconds


  • Operating Humidity Range

    below 90% relative humidity (noncondensing)


  • Sample

    Capillary whole blood, at least 2 μL


  • Maximum Altitude

    3000m (10000ft)


  • Calibration

    Standard Card, Control Solution: (2 levels)


  • Storage temperature

    10-35°C(50-95°F)


  • Operating Temperature Range

    10–35°C (50-95°F)


  • Shelf-life

    2 years. (Do not use the PixoTest Test Strip past the expiration date.)

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CLINICAL RESULTS

To demonstrate the accuracy of our device, here are the results from clinical studies:

Results
Comparison against capillary whole blood by using YSI as reference. A trained technician performed the testing. By collection of 100 subjects with glucose concentration from 41 – 441 mg/dL, the total accuracy is 98.17%.

System accuracy results for glucose concentration < 100 mg/dL

  • Within ± 5 mg/dL
  • 92/172 (55.8%)
  • Within ± 10 mg/dL
  • 158/172 (91.9%)
  • Within ± 15 mg/dL
  • 170/172 (98.8%)

System accuracy results for glucose concentration ≥100 mg/dL

  • Within ± 5 mg/dL
  • 289/428 (67.5%)
  • Within ± 10 mg/dL
  • 395/428 (92.3%)
  • Within ± 15 mg/dL
  • 419/428 (97.9%)

System accuracy results for glucose concentrations between 41 mg/dL – 441 mg/dL

  • Within ± 15 mg/dL or ± 15 %
  • 589/600 (98.17%)
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System accuracy complies with the requirements of ISO 15197:2013.
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Certificates

Providing top quality products is important for us. The following certificates show how excellence counts at iXensor.

 

  • ISO 13485:2003 & EN ISO 13485:2012
  • EC Certificate
  • GMP Certificate
  • PixoTest BGMS: ISO 15197:2013

 

What is diabetes?

Diabetes is a chronic condition. The term describes a group of metabolic diseases in which individuals have high blood glucose (blood sugar), either because insulin production is inadequate, because the body’s cells do not respond properly to insulin, or both.
Insulin allows blood cells to absorb glucose from the food we eat so it can be transformed into energy. The following symptoms are typical of diabetes, but can often go unnoticed.

Symptome bei Diabetes:

  • Frequent urination
  • Increased hunger
  • Frequent thirst
  • Weight loss
  • Excessive thirst
  • Blurry vision
  • Tingling or numbness in the hands or feet
  • Increased infection

If you experience some of the symptoms of diabetes, schedule an appointment with your doctor. Early treatment can decrease the risk of complications, such as skin infections, eye problems or diabetic neuropathy.

Types of diabetes

 

Pre-Diabetes:

Pre-diabetes describes the condition where blood sugar is higher than normal. If blood sugar levels are not controlled carefully, pre-diabetes will develop into type 2 diabetes within 10 years. It is possible to restore blood glucose concentration to normal by leading a healthy lifestyle by taking frequent exercise, maintaining a healthy weight, and eating healthy food.

 

Type 1 Diabetes:
Type 1 Diabetes is also known as insulin-dependent diabetes, and represents around 10 % of all diabetes patients. In Type 1 Diabetes, the pancreas produces limited or no insulin, and patients need to inject themselves with insulin to control their blood sugar. Type 1 Diabetes can occur at any age and is most commonly diagnosed under the age of 20.

 

Type 2 Diabetes:
In Type 2 Diabetes, the pancreas does not produce enough insulin or the insulin does not work as effectively as it used to. Type 2 diabetes accounts for about 90 % of all diabetes cases. It mostly occurs in adults who are over the age of 40 and overweight. Type 2 diabetes can be controlled through healthy diet, decreasing weight, exercising, taking an insulin pill or injecting insulin.

 

Gestational Diabetes:
Pregnant women are diagnosed with gestational diabetes when their blood glucose concentration is higher than normal. By controlling weight and consuming a healthy diet, pregnant women can lower their chance of developing gestational diabetes and keep their blood sugar at a safe level.

 

How it Works

Faq's

To perform a test, download the PixoHealth app through the Apple Store or Google Play, open the app and follow the instructions in the user guide.

Yes, every user has to log in to his own personal PixoHealth app account.

When you remove the device from the packaging, please ensure that the lancet device is at the top of the device and the white circle sample collector is facing up.

Twist off the protective cap. Place your finger on the top and press firmly. You will then feel a slight prick.

No, it is for one-time use only.

Only the PixoTest® Test Unit will work with PixoHealth app.

Yes. After registering for the PixoHealth app, your personal data and measurements will be saved in the app and sync to your account on the web portal.

Yes, the PixoTest® system needs calibrating when you use it for the first time. Please take out the standard card included in each pack and follow the instructions in the app to perform a calibration test.

Currently PixoTest® system is compatible with iPhone 5S, 6, 6 plus and Samsung S6. The PixoTest® system is not validated to work with any tablets, and you can find latest compatible smartphone information at www.ixensor.com.