Blood Glucose Monitoring Developments Focus on Mobility, Convenience

According to the Centers for Disease Control and Prevention (CDC) more than 29 million U.S. residents have diabetes. The agency also reports that medical costs for diabetics are twice as high as nondiabetics. For the diagnostics industry, these statistics indicate a need for products that can help patients monitor their blood sugar and cope with their diabetes. To better manage the disease, diagnostics are striving to make blood glucose testing more convenient and more mobile.

FDA approves new Bluetooth connected mobile system
In late November, the U.S. Food and Drug Administration (FDA) granted Ascensia Diabetes Care approval to market the CONTOUR® NEXT ONE Blood Glucose Monitoring System (BGMS), a Bluetooth connected meter that connects to a mobile app. The app stores and analyzes blood glucose measurements taken by the meter to help patients monitor and manage their blood glucose. Ascensia announced the FDA approval and indicated it expects to bring the device to market early next year. Here are some details about the system:

• App is downloadable from Apple App Store and Google Play

• 95% of results within ±8.4 mg/dL or ±8.4% of laboratory reference values for glucose concentrations < 100 mg/dL or ≥ 100 mg/ dL (fingerstick)

• Meter provides results, reminders, alerts

• System includes electronic log for patient to report meals, activities and medication

• Optional cloud-based storage of data

• System facilitates email communication of reports to provider

Breathalyzer affords pain-free monitoring
Also in November, two Western New England University Professors announced development of a hand-held breathalyzer that measures the acetone in a diabetic patient's breath to help monitor blood glucose and determine when insulin is needed. The professors presented research regarding their device at the 2016 American Association of Pharmaceutical Scientists Annual Meeting and Exposition (Denver, CO). Currently the device is the size of a small book but the professors indicate an intent to make it smaller. They hope to have the device available next year.

Dr. Ronny Priefer, one of the developers, indicated in a statement, "We believe [this non-invasive technology] is a necessary alternative to the finger-stick approach for people living with type 1 and type 2 diabetes. … because up to 66% of diabetics avoid doing the finger-stick testing due to the invasive and painful nature that patients must endure between 4-12 times a day."

Monitoring system gives providers visual snapshot
Earlier this fall, Abbott received FDA approval for a new glucose monitoring system, FreeStyle Libre Pro, which provides "a visual snapshot of glucose data, known as the Ambulatory Glucose Profile (AGP)" according to the company. The snapshot reports glucose levels and identifies trends in the levels to help drive treatment. Features:

• Clinicians apply a small, round, self-adhesive, sensor on patient's upper arm

• Sensor remains in place up to 14 days, measuring glucose every 15 minutes via a filament inserted below the skin

• Patient reports to provider after wearing sensor and provider downloads data stored in sensor.

"This novel technology provides a solution to the ongoing challenge of the need for complete and dependable glucose data. This data is imperative for not only the doctor but also for the patient to help them achieve optimal health," said Jared Watkin, senior vice president, Diabetes Care, Abbott.

FDA offers guidance for development of test systems
To ensure safety and efficacy of the devices used to monitor diabetic patients, in October, the FDA issued two new guidance documents relevant to blood glucose test systems:

• Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

• Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use

These documents finalize draft guidance provided in 2014 and provide manufacturers suggestions about study type and information that should be submitted in 510k premarket applications for blood glucose devices.

"Together both guidance documents can improve the accuracy and safe use of blood glucose meters, giving health care providers and people affected by diabetes safe and effective tools to monitor and manage their blood glucose levels in health care settings and at home," the FDA said in a statement announcing the release of the guidance documents. "The FDA is also reaching out to health care professionals, people affected by diabetes and diabetes patient advocacy groups to provide these guidance documents and to explain how the adoption of these recommendations by industry will result in improved new devices and ultimately benefit these groups."

With that goal of reaching out to stakeholders in mind, the FDA held a webinar to discuss the guidance documents on Nov. 21, 2016. The FDA indicated that previously, manufacturers of such devices sought over-the-counter clearance but the agency believes that a distinction is necessary between different use settings. These guidance documents thus address variables that can affect accurate use of monitoring devices in the clinical setting and at home. They do not address how the meters should be used or how laboratories should validate the glucose meters. In response to concerns raised by the Centers for Medicare & Medicaid Services and the CDC, both guidance documents emphasize the importance of infection control to avoid transmission of blood borne pathogens.

The agency highlighted the following issues as having been changed or clarified in this final guidance:

• Clinical Laboratory Improvement Amendments (CLIA) clarifications. Monitoring systems cleared for prescription use at point of care won't be automatically CLIA waived but the FDA is sensitive to the need for waived monitors in the point-of-care setting; studies should support both clearance and CLIA waiver.

• Performance goals. For over-the-counter devices the accuracy goals are unchanged but for point-of-care testing, the accuracy goals were reduced

The guidance documents are available on the FDA website:

• Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM380327.pdf

• Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM380325.pdf

The slides presented by the FDA at the Nov. 21, 2016 webinar are available at: http://www.fda.gov/downloads/Training/CDRHLearn/UCM529929.pdf

Takeaway: Industry seeks to make testing easier, less painful and more convenient for clinicians and the millions of patients battling diabetes.