Easy Light Glycometer (ELG)

Non-invasive

Easy Light Glycometer

 

ELG3 Pre-Market Device & Application 

 
ELG product shot 2.jpg
 

How it works

  • Placement of thumb surface at center insert

  • Sensor takes the reading

  • Data readouts within 1 to 2 minutes

ELG Advantage

  • First Non-Invasive device for glucose, using visible light technology (safe and effective)

  • First glucose/A1C device proposed and accepted by FDA for an investigative device exception (IDE) which enables a fast-track process to market through 510K submission process.

  • Pre-clinical and clinical trial data (pending completion of clinical trial) indicate ELG results are comparable to OTC and lab results consistent to NIH-VA Clinical Trial Study Accepted Variability Standards.

  • First device designed to measure both A1C and glucose

  • United States Patent approved status as of August 17, 2021 (Patent Number 11,089,979)

ELG product shot 3_V2.jpg
 
 

Linear regression and standard deviations: ELG-3 compared to A&B test strips: the Bland-Altman Plot: a predictive values are consistent with standard glucose oxidase regressive profiles 

This Photo by Unknown Author is licensed under CC BY

This Photo by Unknown Author is licensed under CC BY

 

CDC Biostatistics

2022 National Diabetes Statistics Report

  • 37.3 million people have diabetes (11.3% of the US population) 

  • Diagnosed: 28.7 million people, including 28.5 million adults

  • Undiagnosed: 8.5 million people (23% of adults are undiagnosed)

  • CDC estimates that more than 130 million adults are living with diabetes or prediabetes just in the United States alone.

  • According to the CDC, the SEARCH for Diabetes in Youth Study, reported that trends in overall incidence of both type 1 and type 2

    diabetes in children and adolescents significantly increased from 2002 to 2015.

    Prediabetes Total: 

  • 96 million people aged 18 years or older have prediabetes (38.0% of the adult US population)

  • 65 years or older: 26.4 million people aged 65 years or older (48.8%) have prediabetes

Annual Healthcare Cost

March 2018 American Diabetes Association (ADA)

  • $4 billion in testing

  • $327 billion in related diabetic complications (26% increase from 2012 to 2017)

  • A1C (minimum twice a year) per lab test cost is an average of $170

  • Glucose (variable testing, depending on conditions, averages 3-4 per day) estimated at $1,500 annually

  • Clinical Screening for Diabetes - A1C plus OGTT - $210

  • Most of the cost for diabetes care in the U.S., 67.3%, is provided by government insurance (including Medicare, Medicaid, and the military). (ELG will seek reimbursement schedules from both)

  • The rest is paid for by private insurance (30.7%) or by the uninsured (2%)

  • 10% cost to private physicians