JDRF Goals Supported in FDA Approvals of New T1D Technology

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JDRF has always had an ambitious advocacy agenda to support continued Federal research funding, ensure regulatory frameworks that encourage innovation and promote affordable access to new therapies for people with type 1 diabetes (T1D). After all, to benefit from promising advances, people with T1D need access to them and reliable choices among them—and JDRF is proud to spearhead initiatives that work toward this goal.

Over the past few weeks, we have seen unprecedented progress, including four recent approvals by the U.S. Food and Drug Administration (FDA) of new devices to help people—particularly children—manage their T1D. Along with these recent FDA announcements, the Centers for Medicare & Medicaid Services (CMS) updated its coverage policy this month to reimburse continuous glucose monitor (CGM) platforms that enable Medicare beneficiaries with T1D to share data through a smart device. This change supports the use of CGMs in conjunction with a smart device, including the important data sharing function they provide for patients and their families, a key safety feature of the CGM system.

Other noteworthy announcements by the FDA include:

  • Expanded approval of the MiniMed 670G hybrid closed-looped system, the first commercial version of an artificial pancreas (AP) system. Systems like the MiniMed 670G are diabetes management devices that automatically monitor glucose and provide appropriate basal insulin doses with little or no input from the user (though they still require mealtime boluses). JDRF was pivotal in galvanizing the AP field, working closely with numerous partners, researchers and companies to move the technology forward. The FDA first approved the MiniMed 670G in September 2016 for people 14 years of age and older. With this new FDA approval, the MiniMed 670G is now approved in children between the ages 7 and 13, offering new access to technology that improves glucose control and reduces the burden of T1D to younger children for the first time.
  • Approval of the Eversense CGM system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days. It also permits the sharing of data through the associated app.
  • Approval of the Tandem Diabetes Care®, Inc. t:slim X2™ Insulin Pump with Basal-IQ™ technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia). This is the first automated insulin delivery system approved for use by children as young as 6 years old, and the first insulin pump is designated as compatible with integrated continuous glucose monitoring (iCGM) devices. Tandem has partnered with Dexcom, and the pump will be integrated with the Dexcom G6 CGM.
  • Approval for Insulet’s DASH Personal Diabetes Manager (PDM) handheld, Bluetooth-enabled tubeless pod and paired user/caregiver mobile apps. Those who use Omnipod’s PDM will now be able to control the insulin pump with functions that include taking a mealtime bolus and programming basal rates from the touchscreen device. Omnipod DASH will have a limited launch this summer leading up to broader availability in the United States in early 2019.

These accomplishments follow many years of extensive advocacy by JDRF volunteers, staff, partners and everyone in the T1D community who has contributed time, energy and financial support. JDRF thanks the FDA and CMS for providing more choices to manage T1D, as well as supporting and incentivizing innovation. And while this is a tremendous step forward, JDRF isn’t taking its foot off the gas. In the coming weeks, JDRF will be contacting national health plans to ensure their medical policies include AP coverage for children that is consistent with the new FDA approvals and will continue to partner with the FDA and CMS to ensure access to next-generation diabetes technologies.

There is more work to be done to accelerate future life-changing T1D breakthroughs like these. Learn how you can join JDRF and become an advocate for the T1D community,