Diabetes is the fastest growing disease in history with some 387M or more cases globally estimated this year by the International Diabetes Federation (IDF), a figure that is set to rise roughly 53% over the next two decades. The most disturbing statistic is the 175M or more of those cases that go undiagnosed. The IDF data paints an alarmingly clear picture, diabetes is on the rise in every country on earth; in fact, one out of every 12 humans has diabetes and one out of every two people with diabetes doesn’t even know they have it. The IDF estimates that as many as 628M people globally are pre-diabetic or have Type 2 diabetes (adult-onset or non–insulin-dependent diabetes), with projections through 2030 indicating a 45% jump to around 912M.
Here in the U.S. we are spending more on healthcare to combat diabetes than anywhere else on the planet, with $612B (or 11% of all healthcare spending on adults) spent in 2014 alone, and the American Diabetes Association’s (ADA) data indicates that not only is diabetes the number seven killer in the country, it was also a leading underreported cause of death. Some 40% of people who died of diabetes did not have it listed anywhere on the death certificate according to ADA’s research, and the Centers for Disease Control and Prevention (CDC) estimates that if this trend continues as many as one out of every three Americans will have diabetes by 2050. Troubling statistics indeed when one considers the nearly 5M fatalities this year in the U.S. from diabetes, or one death every seven seconds.
Last year, over 79k children developed Type 1 diabetes (roughly 10% of all cases, formerly known as juvenile-onset or insulin-dependent diabetes) and over 21M births were affected by diabetes during pregnancy as well. Moreover, despite the incident rate being highest among persons aged 40 to 59 years, some 208k Americans under the age of 20 are estimated to have been diagnosed this year according to the ADA. This clearly documents that Type 2 diabetes, once virtually unheard of in people under 30, is now rapidly on the rise, with childhood obesity playing a major role.
Type 1 diabetes can be averted if caught early and diabetics can even turn the disease around completely with proper diet and exercise, but the high number of undiagnosed cases is a serious red flag here, pointing directly to the costs, complexities and invasiveness of testing. Early detection and intervention is absolutely key to preventing Type 1 diabetes, and with average medical expenditures as much as 2.3 times higher for diabetics than those without it, public health organizations and governments are now starting to get serious about creating initiatives designed to tackle the problem.
Many people go untested due to the invasiveness or daunting logistics of existing testing methods, involving blood draws, fasting, trips to the doctor and/or lab, and waiting for test results to come back. The common A1C test for instance (sometimes also called the HbA1c test), which measures an individual’s average blood sugar level over the past few months, requires a sizeable blood sample and is the most common route for testing. The FPG test (fasting plasma glucose) or the OGTT test (oral glucose tolerance, commonly done to check for diabetes that occurs with pregnancy, or gestational diabetes), while less expensive and generally very easy to do compared to the A1C, are similarly problematic, given that patients must fast for 8 to 14 hours prior to taking the test and must still give a blood sample(s).
People’s reluctance to get tested and the subsequent healthcare costs associated with increased morbidity, may have finally met their match though in the form of the novel, non-invasive Scout DS® system from Miraculins, Inc. (TSX-V: MOM) (OTCM: MCUIF). This first-of-its-kind device is a sleek looking, small form factor tabletop system, featuring an LCD display and an arm rest that the patient places their forearm onto for the test. After only about 80 seconds the device painlessly produces a highly accurate score on a scale from 0 to 100 using a series of LED lights and sensors. The device uses a well-established testing methodology called skin fluorescence spectroscopy (SFS) to measure advanced glycation end products (AGEs), which have been vetted through numerous studies over the past 25 years as a highly sensitive metric for gauging the cumulative impact of abnormally high blood sugar and oxidative stress on the body.
Until recently, AGE measurement required a punch biopsy of the skin big enough to require a stitch and a costly/complex assay for which only a handful of academic laboratories had the capability, making this approach to screening for diabetes essentially non-commercially viable. The Scout DS however uses quantitative SFS (multivariate spectroscopy using a unique algorithm) to measure collagen cross-links and other fluorescent AGEs, via a set of unique UV/Blue LEDs to stimulate fluorescence, as well as some White LEDs to compensate for skin tone variations. With more than 3k subjects to date tested in prospective clinical trials, the accuracy and efficacy of the Scout DS for doing rapid, non-invasive screening of pre-diabetes and Type 2 diabetes, by measuring diabetes related biomarkers in the skin, now looks to be firmly established.
The efficacy of this rapid testing technology was even recently demonstrated in a peer-reviewed study (ENGINE) of the Scout DS published in the Journal of Clinical and Translational Endocrinology. The study showed the device’s ability to detect abnormal glucose tolerance just as well as (if not better than) FPG or A1C testing, all without fasting or blood draws, adding further credence to the commercial viability of the Scout DS as a rapid non-invasive screening system for diabetes, as well as the accuracy and robustness of the innovative SFS/AGE testing methodology which lies at the heart of the device’s design. The Scout DS is 61% more sensitive than A1C and 100% more sensitive than FPG (ENGINE study), with a 93% detection rate for Type 2 diabetes (TCOYD1 study), and is 1.4 times better than RCG with an equivalent false-positive rate (random capillary glucose, Greece study), yet the device easily works on people with dark skin (LSS study versus OGTT).
In China, which has overtaken India as the world leader in diabetes cases, with upwards of 92M diabetics (again, nearly half of whom are undiagnosed), there is a massive target market for such a device as the Scout DS. Miraculins hasn’t wasted any time acquiring inroads to this target-rich environment and executed a definitive agreement in August to sell and distribute up to $90M worth of Scout DS devices via Hong Kong-based Catalyn Medical Technologies, Ltd., with Cachet Pharmaceutical Co., Ltd. already tapped as exclusive distributor for mainland China.
Also in August, Miraculins detailed their fast-track strategy for obtaining de novo FDA classification (intended for “novel” devices with a low risk profile) on the Scout DS, with a pre-submission designed to follow up on last year’s filing for feedback from the FDA regarding a clinical/regulatory roadmap for marketing clearance, in light of the reasonable assurance of safety and effectiveness of the device, as well as the absence of any existing or comparable device on the market. Obtaining de novo status from the FDA would put the Scout DS on the road to a Class I or Class II medical device classification (cheaper and easier than a Class III designation) and confidence is high at Miraculins that the FDA will be cooperative, especially when the planned data to be gathered and submitted is supplied.
For more information, visit www.miraculins.com