THE CoG STORY

Non-invasive Hybrid Glucometer provides you a better tool to manage your diabetes Cnoga Medical TensorTip Combo Glucometer (CoG) is a personalized hybrid non-invasive and invasive glucometer that allows you to monitor your glucose levels frequently without constant pricking. Frequent glucose measurement can help you improve your lifestyle management for better glucose level control. Better diabetes management will not only lower your HbA1C but more importantly prevent future disease complications Hybrid – Two devices in One

• During the initial calibration period, you need to measure your glucose levels invasively and non-invasively simultaneously usually for 3 days
• After the initial calibration, the invasive component is calibrating the non-invasive component in order to adjust to your daily changing glucose patterns and your lifestyle

HOW IT WORKS

Four light-emitting diodes (LEDs) within the finger compartment emit a discrete wavelength from ~ 600 ~ 1000 nm through the fingertip. As the light wave passes through the tissue and blood capillaries, the light is partially absorbed and consequently, the light signal is changed. The traversed light is then projected onto a color image sensor (camera). The unique high-resolution camera photographs in real time the light that traverses the fingertip tissue. The color images are stored in a digital memory for analysis by a dedicated algorithm Step 1 Calibration process – During the initial calibration period, you need to measure your glucose levels invasively and non-invasively simultaneously usually for 3 days. Step 2 Insert your finger and get your glucose level Step 3 Improve your health by better managing your glucose levels

PARTS INCLUDED

√ CoG device √ Glucose test strips kit:

• 5 lancet bag (25 lancets per pack)
• 10 glucose test strips vials
• Lancing device

SPECIFICATIONS

• Weight: 112.9gr
• Dimensions : 42.8mm x 48mm x 82mm (H x W x L)
• Suitable for adult diabetics (age › 18)
• A memory of 2000 measurements
• Device Range:
  • Invasive module capability tested: 20-600 mg/dl (1.1-33.3 mmol/L)
  • Non-invasive module tested: 30-600 mg/dL (1.6-33.3 mmol/L)
• All supplies required for the calibration are included with the CoG

WHO IS IT FOR

The CoG device is optimal for people who are not insulin depended, who wish to have better control of their glucose pattern via appropriate food, i.e. what sort of ingredients or food combination may cause rapid glucose increase in the blood or result in a higher glucose level, and/or to improve physical activity, e.g. what is the best time to have a nice walk in the neighborhood and for how long. Frequent measuring assists having a better understanding of your personal glucose pattern and to reduce the HbA1C level (the average glucose in the blood). Device Accuracy: 75% of the results are within 20% accuracy with total MARD (Mean Absolute Relative Difference) that vary between 14%-17%. Please review Q&A for additional information. The CoG is the only accurate non-invasive glucometer existing in the market.

1. What is the accuracy of the COG device?

In clinics accuracy Over 3500 non-invasive measurements were compared against the golden standard reference device (YSI)

1. MARD of 14-17%
2. 75% of the total non-invasive measurements are within 20% ARD (Absolute Relative Difference)

Usability study at home

• Over 18,610 non-invasive readings at home during 12 weeks use test

HbA1C HbA1C indicates an approximation of three months’ average percentage of connected glucose to Hemoglobin. It is recommended to reduce these values towards normal level. Nonetheless, it is not guaranteed that normal values indicate a normal situation. As one may be at hyperglycemia and hypoglycemia with normal HbA1C. Therefore, it is important for each one to have a better understanding of his personal glucose pattern.

• Mean Absolute Relative Diff (MARD)

• Mean Positive Relative Difference (MPRD)

• Mean Negative Relative Difference (MNRD)

9.67% 2.18% -7.49%

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2. How frequently should I measure my glucose level?

We recommend measuring 8 times a day, nonetheless, one may adopt the schedule that suits his/her lifestyle.

3. I am using Insulin; can I adjust my treatment according to the non-invasive results?

An invasive measurement should be performed prior to taking any medication.

4. What is the calibration process?

The CoG device is composed of two module units: an Add-On module for the quantitative measurement of capillary whole blood samples using test strips similar to any ordinary glucometer and a component for the Non – invasive glucose measurement. The Non – invasive module “learns” the user’s unique glucose pattern by a process called calibration. Calibration is achieved by a combination of invasive reading with test strips and non-invasive reading. The calibration measurements should be performed at different times of the day such as:

• Upon waking
• Before breakfast
• 1-2 hours after breakfast
• Before lunch
• 1-2 hours after lunch
• Before dinner
• 1-2 hours after dinner
• Before going to sleep

5. What happens after the calibration ends? Can I start using the device non-invasively?

The device will provide non-invasive results. The device performance can be continuously improved by adding invasive measurements. The device will ask for invasive measurements on the following cases:

1. The non-invasive measurement result is out of the calibration range.
2. When the image acquired is unclear (low blood flow to the finger, dirty finger, dirty lens, etc).
3. When the non-invasive result does not fit with the user’s usual glucose pattern.
4. Nonetheless, at any time the user can initiate an invasive measurement.

6. How many measurements can I preform in a day?

The device is designed for the purpose of enhancing frequent assessment of blood glucose. Therefore, it is recommended to take measurements as frequently as possible throughout each day. Frequent measurements may assist in improving the management of glucose levels, which are influenced by exercise, food, mood, etc.

7. After the calibration process, what is the frequency of the invasive measurements? Is it necessary to carry all the complementary equipment (lancet device and strips) every day?

The number of invasive measurements may vary between users according to their diabetic severity. Adding invasive measurements will assist the device to learn more about physiological changes, therefore, carrying the complementary equipment is not necessary but might be essential.

8. Is there a need for an additional invasive glucometer?

No, the device has an add-on component that acts as an invasive glucometer, allowing you to use the CoG as a non-invasive and invasive glucometer.

9. How to perform a measurement after calibration?

• Insert the finger into the finger chamber – reading will be shown on the screen associated with a blue graph and blinking yellow hand. The reading is completed once the graph is changing into a green graph. At this point, remove finger from the finger chamber.

10. HbA1c– what is it?

The term HbA1C refers to glycated hemoglobin. It develops when hemoglobin, a protein within red blood cells that carries oxygen throughout your body, joins with glucose in the blood, becoming ‘glycated’. By measuring glycated hemoglobin (HbA1C), clinicians are able to get an overall picture of what our average blood sugar levels have been over a period of weeks/months. For people with diabetes, this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications. HbA1C is also referred to as hemoglobin A1c or simply A1c.