Frost & Sullivan’s Advanced Medical Technologies business unit tracks disruptive innovations in diabetes diagnosis and monitoring, and is witnessing a distinct evolution of blood glucose measurement technology from the traditional finger-prick method to more compact, integrated and convenient devices. Read about companies with the latest innovations in this space.
Diabetes is a leading chronic condition affecting an estimated 8.5% of the world’s population and causing an annual economic burden of $1.3 trillion—about 1.8% of the global gross domestic product. About 50% of the cases globally remain undiagnosed. According to the U.S. Centers for Disease Control and Prevention, the United States alone is home to 30.3 million people with diabetes (9.4% of the population), of which 23.8% remain undiagnosed. Some 33.9% of the adult U.S. population is prediabetic (having a higher-than-normal blood glucose level), indicating a pressing need for early diagnosis and monitoring for effective management of the disease.
Monitoring involves measuring blood glucose levels, logging the information, and sharing it with care providers for analysis to receive personalized support. Frost & Sullivan’s Advanced Medical Technologies business unit tracks disruptive innovations in diabetes diagnosis and monitoring, and is witnessing a distinct evolution of blood glucose measurement technology from the traditional finger-prick method to more compact, integrated and convenient devices. Traditional continuous glucose monitoring (CGM) systems are invasive or semi-invasive—especially those that require blood for calibration collected by the finger-prick method. It is also inconvenient in many cases, because users must carry all components (lancets, strips and glucometer) wherever they go.
Non-invasive glucose measurement is considered the holy grail of diabetes monitoring; several semi- and noninvasive approaches and implants are in development, and various avenues to provide data analytics and deliver care are being explored.
MedTech analysts have identified the following companies for their innovations in the diabetes space.
Senseonics (Germantown, Md.)
Millions of diabetics who were hesitant to adopt a CGM system because of the inconvenience associated with frequent sensor replacement now have an option. Senseonics’ Eversense is the first Food and Drug Administration (FDA)-approved system of its kind with a fully implantable sensor. The sensor is unique: it can continuously and accurately measure glucose levels for as long as 90 days, compared with the average 5- to 7-day sensor life in a traditional system. The Eversense CGM system also is equipped with a smart transmitter that can send data to a mobile app that converts the real-time data into easy-to-read charts and graphs. Senseonics received premarket approval to market Eversense in the United States in June 2018; it gained CE approval for commercialization in Europe in 2016.
Cnoga Medical (Israel)
The company’s Combo Glucometer (CoG) is the first and the only commercially available noninvasive product for glucose monitoring. The user only needs to place a finger in the device, which assesses reflected light from tissue via a digital image sensor and then employs proprietary algorithms to measure blood glucose levels. While semi-invasive products require frequent calibration with glucometers and strips (daily or with each sensor change), the CoG device’s initial calibration is a two-week process that requires the user to perform 50 “reading cycles” of two invasive (finger prick) readings and one noninvasive reading. Follow-up calibration is required only once a month. With regulatory approvals in Europe, China, Israel, and Brazil, and an FDA application underway, the company shows significant growth potential.
Abbott (Chicago, Ill.)
With its FreeStyle Libre flash glucose monitoring system, Abbott launched a smart CGM attachable device by combining water-resistant sensor technology with a best-in-class reading system for a painless, easy-to-use, and portable point-of-care system. The system does not require finger-prick calibration; instead, a quarter-size sensor worn on the upper arm for up to 10 days uses a filament inserted just under the skin to measure interstitial fluid. The wearer uses a handheld reader to scan it to determine the current reading and see an 8-hour trend graph. The product is available in Europe and the United States. By offering Freestyle Libre at a price that is 25% less than a standalone CGM in a favorable reimbursement environment, Abbott is making great strides in the market.
The Road Ahead
Frost & Sullivan sees immense potential in the glucose monitoring market, especially with several products in the pipeline that use noninvasive sensors to track glucose levels from teardrops or saliva, or using an earlobe attachment. Developments in spectroscopy and optical technology also are being applied in this space, and the use of digital tattoos and wearable devices for non-invasive monitoring will become more widespread.
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