Statement of Need

Diabetes technology has been divided into two main categories: insulin administered by syringe, pen, or pump, and blood glucose monitoring by meter or continuous glucose monitor (CGM).

The FDA (Food and Drug Administration) creation of a new Class II pathway for interconnected diabetes management devices opens the door to interoperability and accelerated development/use of new functionality. Recently, diabetes technology has expanded to include hybrid devices that both monitor glucose and deliver insulin, some automatically, as well as software that serves as a medical device, providing diabetes self-management support. While technology improves the lives and health of people with diabetes, the complexity and rapid change can also be a barrier to patient and provider implementation, so continuing medical education is necessary to optimize outcomes.

SMBG (self-monitored blood glucose) devices remain a foundation of diabetes management for CGM calibration/verification and overall patient confidence in insulin dosing decisions, particularly when symptoms don’t match CGM readings – “when in doubt, get meter out.” Not all SMBG meters are of equal accuracy, and ensuring meter compliance with ISO (International Organization for Standardization) protocols, along with proper device education, can affect clinical outcomes. Six of the 18 blood glucose monitors receiving Seal of Approval in the Diabetes Technology Society BGM Surveillance Program were manufactured by (in descending order of accuracy): Ascensia, Roche, Arkray, Agamatrix, Abbott, and Roche.

Based on the growing body of supporting evidence, use of CGM is recognized as the standard of care for individuals with Type 1 – and a subset of those with insulin-requiring Type 2 – diabetes. CGM devices offer the ability for diabetes patients and their healthcare providers to dynamically assess glucose levels and trends through a continuous stream of data. As CGM accuracy continues to improve, treatment guidelines by leading societies have incorporated this technology to help patients reduce glycemic excursions, episodes of dangerous hypoglycemic events, and HbA1c, while also enabling patients to spend more time in range (TIR)(70-180 mg/dl or 3.9-10 mmol/l) each day, and enabling providers to utilize novel markers such as GMI (glucose management indicator).

Two approaches to CGM are available for daily diabetes self-management: real-time CGM (rtCGM) and intermittently scanned CGM (isCGM), often referred to as “flash” monitoring. rtCGM systems automatically stream glucose data to the user, provide alerts and active alarms, and transmit the glucose data (trend and numerical) in real time to a receiver, smart watch, or smartphone. The current isCGM system provides the same type of glucose data, but the user scans the sensor to obtain the information. Both approaches provide patients with actionable information about their current glucose level as well as glucose trend and predictive information. Currently, several companies (Dexcom, Medtronic, Senseonics) have personal CGM devices on the US market, with several rtCGM sensors currently available or being evaluated by the FDA. The Flash Glucose Monitoring System from Abbott is the isCGM system currently available. In addition to the outpatient setting, technology for management of diabetes in the hospital is improving and expected to significantly reduce the added burden and risk of diabetes for hospitalized patients.

The insulin pump too continues to significantly evolve. The development of automated insulin delivery via pump – artificial pancreas, hybrid closed loop, Bionic Pancreas, predictive low glucose suspend – all share the same goal: using CGMs and smart algorithms that automatically adjust insulin delivery via the pump. Multiple closed-loop systems are currently in development with unique algorithms designed to deliver insulin based on glucose levels measured with a connected CGM system and the first commercially available artificial pancreas (approved September 2016 for use in people aged 7 years and older), a hybrid single-hormone closed-loop system, reportedly has more than 100,000 users. Safety of this automated technology in real-world settings supports clinical adoption of hybrid closed-loop systems for people with Type 1 diabetes, and future generations of this system with modified features are under development.

Three major companies are producing insulin pumps in the US: Insulet, Medtronic, and Tandem. There are also multiple insulin pump brands on the market and in development worldwide, including Cellnovo, Kaleido, Roche Diagnostics Accu-Chek, and Sooil Dana Diabecare. Several companies are also developing commercial single-hormone closed-loop systems, including Bigfoot Biomedical, Beta Bionics, Diabeloop, Insulet, Tandem Diabetes Care, and Roche. These systems use different combinations of technologies and algorithms. Regulatory support for insulin pump interoperability has been orchestrated by the FDA defining new devices such as ACE (alternate controller enabled) pumps.

Insulin pens enable accurate and convenient delivery; Smart (insulin) Pens are additionally programmed to calculate insulin doses and provide downloadable data reports utilizing a memory function, which recalls dose amounts and timing. The inPen (Companion Medical, Inc.) is the only FDA-approved (July 2018) insulin delivery system, combining an injector pen, bolus advisor, Bluetooth technology, and a smartphone app for users 12-years-old and older. The pen calculates and recommends optimal doses, tracks dose history and timing for up to a year, monitors insulin temperature, allows insulin data to be shared with health providers and insurers, reminds users when a dose is due, and comes in three separate colors, a real potential benefit when keeping different insulins separate.

Key features of integrated diabetes management systems vary and these variabilities validate the need for accurate and credible healthcare provider-to-provider and provider-to-patient education, a vital component of successful outcomes. Diabetes clinical trials data, and education thereof, lags behind technology development and many providers are not familiar with their application; those familiar with the use of these integrated diabetes management devices, and supporting data, need to lead in terms of continuing medical, allied health, and pharmacy education, guiding providers and patients to optimal outcomes.

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