The National Agency for Food and Drug Administration and Control (NAFDAC) has, after many months of documentation and explanations, laboratory and testing, approved a non-invasive glucose monitor that can accurately reads/measures glucose without drawing your blood.
According to the International Diabetes Foundation, there were 1, 702,900 adults living with diabetes in Nigeria in 2015. Up to 40 per cent of people with diabetes can expect to develop chronic kidney disease. Older people with diabetes have a higher risk of stroke. To avoid severe health implications, it is important to control glucose.
According to the distributors, Kainico Ltd, the egm1000 is difficult to compare with solutions that draw blood. It said: “Because many type2 diabetics at the beginning measures themselves as many times daily as the doctor prescribes, but after a while they measure themselves not even once per day.
“Drawing blood is uncomfortable, so it leads to people not measuring themselves. Not measuring is the way back to an unhealthy lifestyle and to high blood sugar, and later to severe health problems.”
The company behind this innovation is Evia Medical Technologies from the United Kingdom.
The company has developed the egm1000 non-invasive glucose monitor, which offers pain-free monitoring of glucose levels. The devise has the European CE mark certification now and also the Nigerian NAFDAC certification. Kainico Ltd is the distributor in Nigeria.
The egm1000 combines ultrasonic, electromagnetic and thermal technologies by using a patented algorithm. It is not a gadget, but a medical devise, which T includes a small clip that is placed onto the user earlobe. Placing the clip on the earlobe activates measurements and an algorithm. Within one minute, the user glucose level is calculated, promptly displayed and verbally announced. When monitoring oneself frequent enough, the egm1000 also calculates and present an estimated HbA1c level, the average level of blood sugar over the past 2-3 months.
The egm1000 is the size of a Smartphone. It is calibrated to each user. There can be up to three users per device.
So how accurate is it? About 97 per cent of its readings are in the clinically accepted A and B zones of the Clarke Error Grid, when compared with a laboratory reference device. Clinical trials have confirmed that it is as accurate as the finger pricking. However when the finger pricking does not clean the finger prior to sticking, the egm1000 is more accurate. When the finger pricking wrongly takes the first drop of blood instead of the second, then the egm1000 is also more accurate.
The desire to develop a non-invasive glucose monitor came from one of the Evia founders, the late Dr. David Freger. David had diabetes and like many who suffer from this life-long debilitating disease, David was sick and tired of pricking his fingers to draw blood several times each day. Together with two of his trusted colleagues, they set out to develop a non-invasive glucose monitor that could provide pain-free measurements.
Following years of intense research and development they determined that the technical challenges of increasing the signal to noise ratio, to obtain a reliable reading without drawing blood, could best be achieved by combining three independent technologies simultaneously. They developed a proprietary and patented approach of using ultrasound, electromagnetic and thermal measurements with a unique algorithm to weigh each measurement and calculate the weighted average of the three readings. The development took a decade.
The device measures tissue/skin glucose and not blood glucose. So it is an indirect measurement. The glucose in the blood can be detected from the tissue/skin after some minutes.