Twenty First Century Health Inc., a new products development company, has announced their acquisition of the exclusive rights from Milton Fuller and Solid State Farms to develop a non-invasive monitor that measures hemoglobin A1c.
Currently, people with diabetes are advised to have HbA1c tests four times per year. The HbA1c test determines average BG levels over longer periods of time (three months) by measuring how much glucose has attached itself to hemoglobin during its 90-day life span. While regular blood glucose meters identify a person’s immediate blood glucose levels, they provide no information as to how those levels have been maintained, like the HbA1c test is able to do.
Though this meter has yet to be submitted for FDA approval, this meter would use radio frequencies to determine A1c levels. If it proves successful it will erase the need to puncture the skin to obtain a blood sample. In addition, it would eliminate costly lab fees and enable people to receive immediate test results in their own home with no discomfort involved.
The device has an anticipated production size of approximately 8 x 4 x 2 inches, it would be battery operated and designed for easy use. According to the company, a person with diabetes would place his or her finger on the base of the device and within seconds receive a digital readout of their HbA1c level.
When completed, the device is expected to sell for $500 to $800.
Milton Fuller, president of Solid State Farm, told DIABETES HEALTH that Solid State Farm and Twenty First Century Health have a joint agreement to seek third-party partners for marketing this and other products to doctors and the general public in the near future. While Fuller said they do not release their timelines for expected FDA approval, he did say the waiting period is “getting short.”
He also commented that the progress on the non-invasive HbA1c monitor has been very rapid because of their past work trying to develop a non-invasive glucose meter for everyday blood sugar tests. These studies are still underway, and Twenty First Century and Solid State are expecting to have news “soon” on the development of a non-invasive BG monitor that they are currently testing.