Blood glucose monitoring innovations to disrupt market

According to Frost & Sullivan, the diabetes monitoring market is currently valued at $10.71bn, and is forecasted to grow at a compound annual growth rate of 5.4% to reach $14.68bn in 2022. This market consists of two major sub-segments: Self-Monitoring of Blood Glucose (SMBG) and Continuous Glucose Monitoring (CGM).

The finger-prick test, also called SMBG, is the most common technique used for measurement of blood glucose levels; however, it is painful and inconvenient, which could hinder regular testing and affect diabetes management. Another technique gaining wider acceptance is the CGM, in which a sensor linked to a CGM device is placed under a patient’s skin but not into the bloodstream. The sensor measures glucose levels in the Interstitial Fluid (ISF). Though it is less invasive than the finger-prick test, its accuracy is dependent on the equilibrium of glucose levels between ISF and blood, which accounts for a time delay in the measurement and hence requires frequent recalibration using the finger-pricking test. CGM does not replace the traditional SMBG technique as it also requires measurement of blood sugar with a regular glucose meter a few times a day. Moreover, sweat, temperature changes, and electrostatic noise can affect its accuracy.

Technology Advancements Focus on Improving Patient Convenience and Becoming Integrated Devices

Innovations in the glucose monitoring space are making devices smaller and more convenient. New semi-invasive, implant, and noninvasive approaches are being developed. Various avenues to provide data analytics and care delivery support using glucose and other data (e.g., food intake) are becoming available. Some of these innovations are described below.

Finger Pricks

Until other forms of glucose monitoring become readily available and less expensive, traditional finger-prick monitors will remain in wide use. Advancements in this area are focusing on patient convenience and integration. Some of innovations are described below:

• Intuity’s All-in-One Pogo System reduces procedural steps to three: press, test, and reload (after ten tests). No lancet is needed, and one cartridge is sufficient for ten tests.
• Sentec’s fully integrated system uses electrochemical biosensor in a cassette form and houses up to 100 tests on a continuous test tape.
• SugarCube’s fully integrated system is Bluetooth-enabled, all-in-one glucose testing kit. It communicates with the SugarCube app to provide personalized diabetic lifestyle management to its user.
• Several companies are using a smartphone as a glucometer. Gmate’s smart system allows the user to plug the meter into a smartphone and insert a test strip to begin the test, which reduces the number of items to carry; Dario’s system goes a step further by providing a pocket-size, all-in-one holder-meter; and Akibah uses a smartphone case as a glucometer. Its Glucase has compartments to store test strips and lancets. The case itself carries out the test and sends results over Bluetooth to a smartphone app.

Semi-Invasive Monitors

Semi-invasive technology comprises a hypodermic needle inserted to a level where capillaries are abundant but nerve endings are scarce. This transdermal or subcutaneous insertion often has the sensor component sticking on the surface, or has through-the-skin or skin-adhered components. This device is designed to automatically obtain and analyze series of static blood samples over a period of time. It involves minimal pain and requires limited user intervention. Several devices that are still in the approval and commercialization stages in the United States have the potential to overcome challenges posed by the finger-prick test and the traditional CGM monitoring, which may be less accurate and requires recalibration using the finger-prick method. Devices also may connect with a wearable insulin pump for closed-loop blood glucose control. Solutions include FiberSense from EyeSense, Eversense from Sensionics, and FreeStyle Libre from Abbott Laboratories.

Implants

Implants are touted to be more precise and have longer lives than semi-invasive sensors. Fully implanted sensors last for several months, while semi-invasive sensors last about a week. A physician surgically implants a sensor using a delivery system at an insertion site. Inaccurate readings due to external sensor movements are eliminated. EyeSense, Glysens, Profusa, and Optiscan are among the companies developing products.

Non-Invasive Monitors

Non-invasive monitoring technologies that are under development include:

• Smart contact lenses: Google, Novartis, NovioSense, Medella Health, and Freedom Meditech are developing lenses that measure glucose levels in tears.
• Fingertip devices: LighTouch Medical is testing a device that uses spectroscopy to analyze blood glucose; Glucosense Technologies is developing a laser-based device; and OrSense has an optical device that tracks glucose and other parameters using occlusion spectroscopy.
• Earlobe devices: The GlucoWise device measures glucose levels in the skin using radio waves; it can also be used at the fingertip. GlucoTrack by Integrity Applications uses ultrasonic, electromagnetic, and thermal technology to track blood glucose levels.
• Saliva analyzers: The iQuickIt Saliva Analyzer from Quick LLC uses a wick to draw in saliva to measure glucose levels.
• Wearables: GlucoVista is developing a wrist wearable to monitor glucose continuously and non-invasively using infrared technology. ONESENSE’s Photonic Glucose Sensor can be worn on the arm to keep track of glucose levels, especially to alert the wearer during hypoglycemic events; the sensor complements, instead of replaces, the traditional finger-prick monitor. Sano is developing, in stealth mode, a purported wearable device to non-invasively track glucose levels. The University of California, San Diego, has developed a thin, flexible device—akin to a digital tattoo—that uses electric currents to measure glucose concentrations. PKvitality has developed a wearable wristband called K’Track, which uses microneedles to detect glucose levels in interstitial fluid.

Innovative Smart, Connected Monitors to Improve Care Delivery Support

Knowing glucose levels is no longer sufficient; maintaining and sharing records with care providers, understanding the data, and making informed decisions is necessary to better manage diabetes. Smart, connected monitors are helping patients easily share their glucose level logs with providers.

For example, YOFiMeter is developing an integrated blood glucose monitor with a patented lancet cassette system. It uses cellular networks, at no cost to the patient, to instantly transmit data to the cloud. Sharing software allows healthcare practitioners to access real-time information for decision support during remote and in-person visits. Value-added features include a glucometer that also functions as a pedometer, and the ability to attach voice notes to readings for future reference.

Visiomed Group’s BewellConnect uses a series of connected devices including a thermometer, weighing scale, ECG, and oximeter, for health assessments. Diabetics have two options: a dongle to connect their existing glucose monitors or a connected glucose monitor. All logs and readings are automatically transferred to the connected smartphone app. Users can track their health data on the app and make queries to the artificial intelligence-enabled BewellCheck-up system to evaluate results. In emergencies or for serious health concerns, users can connect with registered doctors through the MyDoc service to get instant medical advice.

What’s the Future?

Other products that are being developed focus on allowing providers to collect glucose level logs from patients regardless of monitoring device. Future research will be directed toward real-time synchronization with patients’ blood glucose monitoring devices to get instant updates and alerts for those requiring immediate medical intervention.