A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6
Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
Dr. Theise’s article elucidates a new understanding of the interstitial space as being supported by an interstitium organ, which has significant clinical management ramifications for diabetics undergoing continuous glucose monitoring. Elucidation by confocal laser of in-vivo endo-microscopy showed that the dermis is not dense connective tissue, as had previously been thought, but instead is a part of an interstitial space present in all tissues and organs and which is fluid filled and held open by a collagen bundle lattice. This finding suggests that needle placement of the monitors has not been optimized to lie fully within the interstitial place. Instead, the needle passes through the interstitial space into the sub-dermis. This deeper insertion may be prone to trigger a scar reaction or may dislodge the needle from the site causing the inaccuracy in data provided by the continuous glucose monitors.
Pop Test has developed a proprietary device platform to optimize placement of the sensor needle wholly within the dermal interstitium providing accurate data. Moreover, knowing the cellular and matrix components of the interstitium in ways previously unappreciated, allows for our development of proprietary materials that will not trigger interstitial fibrosis or other interfering reactions. These changes should lead to a more durable and optimized placement of glucose sensors. The Pop Test interstitial device will make continuous glucose monitoring the clinical success it should be. CGM makers such as Roche (OTCQX: RHHBY), Abbott (NYSE: ABT), Dexcom (NASDAQ: DXCM), and Medtronic (NYSE: MDT) might wish to take notice.
About Pop Test: Pop Test LLC is the company that developed a new saliva-based diabetes diagnostic platform that has been featured in presentations at the American Diabetes Association’s Annual Scientific Conference.
Pop Test has signed a Letter of Intent with QualHealth (www.myqualhealth.com) for commercialization of key technology.
QualHealth has provided a program through clinical dentistry which will significantly increase the number of diabetes screenings performed in the U.S. and around the world to help improve early detection of diabetes. QualHealth is planning a launch of the Pop Test Saliva Diabetes Screening tests in 2019.
