ELG3 Corporation is in the investigative phases for a diabetes category game changer that has the potential to rival standard methods of glucose testing with a U.S. market size of about 30 million patients. For this study, we are looking for 100 patients, ages 25-65, who are relatively stable and with glucose levels less than 300 mg/dl.

Device Overview

The Easy Light Glycometer (ELG) is the first product designed specifically for patients with type 1 and 2 diabetes mellitus that is in a clinical trial to measure both A1C and glucose, without the pain and inconvenience of a fingerstick or inserted device. The ELG sensor system uses pulse photometrics to measure blood glucose concentrations.

Unlike current OTC finger sticks and under-the-skin CGMS, this device does not puncture or even scratch the skin. Through the investigation, we hope to demonstrate that the ELG device delivers the same level of >95% on both precision and accuracy as compared to standard whole blood assays for A1C. We hope to enroll a diverse diabetes patient profile to establish comparable precision and accuracy.

Using standardized IFCC methods, based on data generated to date, ELG falls within the acceptable tolerance

Functional Details:

• The ELG is designed to measure both A1C and glucose using visible light technology to detect A1C through vascular tissue and then quantitatively calculate glucose concentration using a modified Beer-Lambert optical density measure
• A1C and glucose have proportionality and ELG correlates to physiologic glucose concentration in real time, using A1C, as a benchmark
• This unique correlation of data provides a robust comparison to current FDA approved whole blood testing methods and requires no additional OTC calibration readings
• Measurements are in mg/dl
• ELG quantifies plasma glucose concentration and the values are the universal equivalent to OTC fingerstick meters, even those with related H/H issues
  

The Easy Light Glycometer will be efficient and affordable

• Patients simply insert their thumb into the ELG device to get readings in less than two minutes. They can use it as often as needed, 24x7.
• The ELG will hopefully streamline data management and provide robust reporting by representing data by the day or week. This monitoring may be helpful to diabetes management.

510(k) Status:

ELG-3 Corporation intends to submit a 510(k) for the ELG device as soon as the clinical data, as well as the complete manufacturing information is available. ELG expects it to be cleared for marketing as a Class 2 device. This is the likely regulatory pathway per previous submissions. We remain in close contact with the FDA during the clinical trial process.

Currently we have 80 data points comparison to finger sticks fasting and non-fasting glucose OTC devices on the market. In addition, ELG shows CGMS “like” patterns, we will have more data from the 100 subjects with the intention of proving that ELG readings are consistent with CGMS.