From healthline.com
With the New Year right around the corner, we’re keeping up our tradition of reviewing what made this past year one to remember in the Diabetes World.
Of course, we’ve all endured the continuing impact of the COVID-19 pandemic, from overrun hospitals to economic fallout to cancelled in-person events, to delayed timelines on new diabetes devices and product shipping woes worldwide. It’s been a lot to navigate, in many ways a continuation of the troubled previous year.
Meanwhile, pretty much everything is still being seen through the lens of this pandemic and a tense political climate in the United States.
Yet there does seem to be hope on the horizon, with vaccine availability and a slowly improving economic situation. In the diabetes arena, we look forward to a resurgence of new product approvals in the near future as the Food and Drug Administration (FDA) regulators get caught up.
Here’s a look at the big themes defining 2021 in diabetes:
COVID-19 impact: Vaccines, variants, virtual events
The pandemic continued to be the biggest story of 2021, in general and for those with diabetes.
The start of the year brought many discussions about state-led vaccination priorities, and how soon people with diabetes would be able to get those shots while they were still in short supply. The new variants — with Greek-lettered names Delta and Omicron — have renewed concerns about just how quickly we all may find our way past this pandemic.
Remarkably, one of our own in the Diabetes Community was a pivotal part of developing the COVID-19 vaccines. Dr. Drew Weissman at the University of Pennsylvania was one of the researchers who spent years digging into the science behind mRNA vaccines, and he’s also lived with type 1 diabetes (T1D) for more than 50 years. As it turns out, Weissman’s work has made him one of Times’ Heroes of the Year for 2021!
As we saw in 2020, the continuing COVID-19 crisis meant most of the planned diabetes events and conferences during 2021 remained virtual or at least in a hybrid format. That included the huge annual American Diabetes Association’s 81st Scientific Sessions event that was again all online. One exception was the annual Friends For Life conference at DisneyWorld in Orlando, Florida, which is held each year in July. This year, it happened to fall into a perfectly-timed bubble of summer weather and easing restrictions that allowed this event to be held in person this past summer.
Diabetes product delays
There were a few FDA approvals in 2021 that made headlines: Bigfoot Biomedical’s first connected Unity insulin pen system in May, the FreeStyle Libre 2 mobile app in August, and Medtronic’s new 7-day extended wear infusion set in September.
However, most of the FDA filings are taking longer than expected, lingering in the review process due to pandemic-caused delays with the agency being short-staffed. Clinical trial research for new products was also slowed down and even halted in some cases. The result: many big expected diabetes product approvals did not happen this year.
Many people with diabetes (PWDs) also experienced shipping delays for their needed supplies and medications, tied once again to COVID-19 issues.
Many shared stories online of how their supplies and medications were delayed or not immediately accessible through mail-order and retail pharmacies, as well as third-party distribution companies. Most of this is tied to either supply stock or staffing shortages that have plagued many businesses globally.
In fact, in November 2021, Novo Nordisk actually experienced a brief manufacturing problem and subsequent shipping delays for its insulin brands, leaving many in the United States without immediate access to their life-sustaining insulin before everything was cleared up.
100 years of insulin
The year brought a milestone in diabetes history: a century since insulin was first discovered in 1921, by a team led by Toronto-based researchers Dr. Frederick Banting and Dr. Charles Best. They began testing insulin in their lab earlier that year and made the critical discovery of isolating insulin in July 1921. It was then first delivered orally into a patient on Dec. 21, 1921. The first-ever patient to receive an insulin injection came on Jan. 15, 1922, with 15-year-old Leonard Thompson. The rest is history, as they say.
For this century mark, many advocacy initiatives, awareness campaigns, and fundraising efforts have embraced the 100th insulin anniversary theme. One of those included the World Health Organization (WHO) that developed a Global Diabetes Compact to advocate on the need for affordable insulin.
Insulin prices remain at crisis level
Unfortunately, the current state of insulin affordability — or lack thereof — clouds this 100th anniversary. Many media outlets have published stories through this milestone year highlighting the insulin pricing crisis here in the United States.
Our Diabetes Community did see some changes materialize, but they only ever seem to be incremental improvements rather than full-scale price-lowering measures that help everyone.
- In a big move, Walmart added a ReliOn version of the bolus (fast-acting, mealtime) insulin Novolog to its line-up of insulin products available for a lower cash price of only $35.
- Yet, that pails in comparison to the 3-year drug pricing investigation report published in early December by the House Oversight Committee that touched on insulin pricing practices, confirming the current emphasis on aiming for profit over patient health.
- Diabetes advocates met with President Joe Biden and Vice President Kamala Harris at different points in the year, traveling to the White House to discuss insulin pricing. Some of that was tied to the push for the proposed Build Back Better Act, the massive Democrat-led infrastructure bill that included a potential federal insulin copay cap of $35 for both Medicare and commercial insurance plans. That bill passed the U.S. House but stalled just before the year’s end in the Senate.
Aside from those big themes of 2021, a number of other notable diabetes-related news stories captured headlines throughout the year:
New long-acting insulins
Several new formulations of basal (long-lasting, background) insulins made headlines throughout the year.
- The Viatris-Biocon insulin Semglee — which was approved in 2020 as a knockoff of Sanofi’s Lantus — received the first-ever interchangeable designation, meaning it can be swapped out with other basal insulins. Semglee launched starting in November, in both a “branded” and “unbranded” form. The lower-priced unbranded Semglee had an initial list price of $147.98 per package of five 3mL pens and $98.65 per 10mL vial; the branded version of Semglee, subject to insurance coverage, was $404.04 per package of five pens, and $269.38 per glass vial.
- In December, the FDA also approved another long-acting Lantus-knockoff made by Eli Lilly, a biosimilar insulin named Rezvoglar. That will be available in 3mL pens, and Lilly will likely launch that product and offer pricing details in 2022.
Digital diabetes data in the news
A number of news items touched on digital diabetes data. A big one came in July as the FDA cleared continuous glucose monitor (CGM) company Dexcom to release its real-time API, allowing other companies to directly tie Dexcom CGM data into their devices. Garmin was the first to do so, and the open-source Sugarmate platform (now owned by Tandem Diabetes Care) took a hiatus before finally returning later in the year.
The medical establishment made a landmark embrace of do-it-yourself (DIY) technology in the diabetes space, with an international consensus statement being published in The Lancet Diabetes & Endocrinology. This is the first-of-its-kind guidance for healthcare providers on treating patients using DIY diabetes systems.
The authors noted that healthcare providers should facilitate and support people with diabetes who choose this DIY tech to automate their insulin delivery systems, and work with patients to set “realistic goals” and minimize any risk. They also called for local policies supporting open-source closed loop systems as “fostering ethical medical principles and evidence-based medical treatment.”
Diabetes in the spotlight
From beginning to end, diabetes was certainly on display this year for people around the world to get a glimpse of:
- Super Bowl ad. We started 2021 with celebrity singer and actor Nick Jonas appearing in a 30-second Super Bowl ad for Dexcom, with him wearing his G6 CGM in a push to raise awareness about the product as well as type 1 diabetes in general. Not all were pleased about that commercial, though, as DiabetesMine reported here.
- Lila Moss on runway. At the end of September, the then 18-year-old daughter of supermodel Kate Moss walked the runway as part of the Fendi-Versace collaborative collections show in Italy and wore her tubeless Omnipod insulin pump on her thigh on full display of the audience and cameras.
- Este Haim. As part of the sister trio rock band HAIM, bassist Este Haim often puts her diabetes gear on display in her Instagram photos, social media posts, and media interviews. This spring, the group also made rock n' roll history as the first all-female band nominated for the Grammy’s top prize.
- Miss America. At year’s end, news hit that the Smithsonian was marking the 100th anniversary of the Miss America competition by bringing a new display to the museum. That includes memorabilia from Nicole Johnson, who many may recall was crowned Miss America in 1999 and notably was the first to wear her Minimed insulin pump on stage for the world to see. Johnson wrote on Facebook: “So delighted to be a part of the Smithsonian Institution. I was thrilled to donate my insulin pump, 2-piece swimsuit, several photos, and precious letters from children with diabetes sent to me during my time as Miss America 1999. I am so honoured to be included in this exhibit with an incredible group of trailblazing women!” More detail on the exhibit can be found via the Smithsonian.
Goodbye, diabetes advocates
Our Diabetes Community sadly said goodbye to some incredible people and advocates in 2021, who’ve made a mark on our community and world for the better:
Erin Gilmer – a diabetes and disability rights advocate, passed away at 38 years old in July. As the New York Times reports, Gilmer “fought for a more compassionate healthcare system, bringing an extensive knowledge of policy and even more extensive first-hand experience as a patient.”
Scott Strange – this long-time T1D advocate and blogger passed away in early November, at 58 years old. He volunteered at many advocacy conferences and meetings, and generously gave much of himself to people with diabetes over his impressive 50+ years of living with this condition. In particular, he wrote a lot about mental health with diabetes and gave many within the community a voice for sharing their own stories and struggles on the mental health front.
Thom Scher – the 33-years-young president and CEO of leading diabetes non-profit Beyond Type 1 surprisingly passed away in early December in New York City. Scher did not live with diabetes himself, but was a passionate advocate who had a bold vision to challenge the status quo in terms of what a non-profit organisation could do. He led Beyond Type 1 to serve people living with both T1D and type 2 diabetes, providing resources to this community in multiple languages all over the world.
Anne Rice – the famous Vampire novel author who was extremely public about her diabetes diagnosis and struggles, died in mid-December at 80 years old. She had struggled with complications of diabetes since her delayed diagnosis in 1998.
These beautiful souls and others lost this year will be sorely missed!
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