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It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: Lilly becomes the first of the big three insulin makers to settle a class action lawsuit over pricing, the FDA approved Beta Bionics’ iLet system, oral meds trialed for T2D seem to work as well as Ozempic injectable, Lego adds a T1D “friend” to their line and a big win for an American Ninja Warrior competitor with T1D.
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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
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Our top story,
Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit accusing the company of overpriced its insulin. As part of the settlement, Lilly has agreed to cap out-of-pocket costs for its insulin at $35 per month for four years. That’s three months after Lilly said it would cut insulin prices to that level.
The lawsuit was filed in 2017, against insulin makers Lilly, Novo Nordisk and Sanofi. Plaintiffs claimed the companies joined in an “arms race” to raise list prices of their meds while the “real” price to pharmacy benefit managers remained constant or in some cases dipped.
Price increases of insulins that previously cost $25 per prescription were pushed up to $450, the suit said. The increases, taken in “lockstep,” were “astounding and inexplicable,” according to the class action lawsuit. Novo and Sanofi have yet to settle this case.
The FDA is changing its draft guidance for industry regarding Antidiabetic Drugs and Biological Products. It’s been 15 years since an update. Topics covered in the draft guidance include:
Hemoglobin A1c (A1C), a measure of average blood sugar, remaining an acceptable primary efficacy endpoint
The FDA now considering a reduction in the risk of hypoglycemia (low blood sugar) to be a clinically relevant outcome measure for diabetes drug clinical trials, when accompanied by either a reduction or maintenance of an acceptable A1C.
The use of data collected by continuous glucose monitoring (CGM) systems, which allow for nonstop, passive glucose monitoring, in clinical trials to potentially support hypoglycemia labeling claims. Recent advancements in CGM technology have led the agency to recognize the advantages of data collected from these systems in clinical drug development. The FDA will be accepting comments on the guidance until August 24, 2023.
The iLet bionic pancreas from Beta Bionics gets FDA approval for people with type 1 age 6 and up. This is a unique system in that it starts with only the user’s weight and requires meal announcements – no carb counting – to automate blood sugar. It will launch with the Dexcom G6 CGM. You’ll hear from the company CEO this Tuesday in our next episode where we do a deep dive into the system.
Researchers had observed an increased incidence of type-1 diabetes cases during the COVID-19 pandemic. Now, a new study has confirmed the link and established a temporal association between the development of type-1 diabetes in children and infection with the SARS-CoV-2 virus.
The new study published in Jama Network was the first research that used data, which indicated if the type-1 diagnosed children previously had COVID-19 infection.
The researchers found the likelihood to develop type-1 diabetes increased by 57% in children who had a confirmed COVID-19 infection, compared to those who did not have the infection.
New oral medication from Pfizer seems to stack up well next to Ozempic for weight loss. New study looked at people with type 2 found danuglipron when given twice a day, lowered blood sugar in patients at all doses and reduced body weight at the highest dose after 16 weeks.
The weight loss with danuglipron is of a similar magnitude to that observed in the mid-stage data for Novo Nordisk’s semaglutide, known as Ozempic when used for diabetes and Wegovy for obesity.
The treatments, including Pfizer’s danuglipron, belong to a class of drugs that mimic the gut hormone glucagon-like peptide-1 (GLP-1), which works by suppressing appetite and were initially developed to treat type 2 diabetes.
Pfizer is also testing another oral diabetes drug, lotiglipron, which is given once daily and has said it plans to initiate late-stage development of only one of the two candidates.
The company believes an oral therapy could appeal to patients who want to avoid injections.
Artificial intelligence (AI) algorithms used to screen for and predict type 2 diabetes may be racially biased, which could perpetuate health disparities, according to a study published last week in PLOS Global Public Health.
Risk prediction models for type 2 diabetes have shown promise in bolstering early detection and clinical decision-making, but the researchers pointed out that these models can bias the decision-making process if risk is miscalibrated across patient populations.
The research team found that the Framingham Offspring Risk Score underestimated type 2 diabetes risk for non-Hispanic Black patients, but overestimated risk for their white counterparts.
The ARIC Model and PRT overestimated risk for both groups, but to a greater extent for white patients.
Research like this highlights that while data analytics and AI approaches may help find gaps in chronic disease management and care, racial disparities are still a major obstacle to achieving health equity for diabetes patients.
A 2021 study of city-level data revealed significant disparities in diabetes mortality rates across the United States.
The analysis sourced data from the 30 largest cities in the US and demonstrated that mortality rates were higher for Black individuals than for white individuals. Disparities were also found to be up to four times larger in some cities compared to others, with Washington, DC experiencing the highest rates of diabetes mortality inequities.
1 in 3 adults with Type 2 diabetes may have undetected cardiovascular disease. Elevated levels
However, mildly elevated concentrations of of two protein biomarkers that indicate heart damage may be an early warning sign of changes in the structure and function of the heart, which may increase the risk for future heart failure, coronary heart disease or death.
Researchers analyzed health information and blood samples for more than 10,300 adults collected as part of the U.S. National Health and Nutrition Examination Survey from 1999 to 2004. Study participants had reported no history of cardiovascular disease when they enrolled in the study.
One-third (33.4%) of adults with Type 2 diabetes had signs of undetected cardiovascular disease, as indicated by elevated levels of the two protein markers, compared to only 16.1% of those without diabetes.
MTV Documentary Films has acquired worldwide rights to Pay or Die, a film about Americans living with diabetes who face a cruel choice: pay the “extortionate” cost of insulin charged by pharmaceutical companies or risk death.
Scott Alexander Ruderman and Rachael Dyer directed and produced the documentary, which premiered in March at SXSW. MTV Documentary Films plans a theatrical release later this year, followed by a debut on streaming platform Paramount+.
Those personal stories in the film stretch across the country. “From a mother-and-daughter struggling to rebuild their lives after spending their rent money on insulin, to a young adult diagnosed with Type 1 diabetes during the COVID-19 pandemic, to a Minnesota family thrust into the national spotlight when their 26-year-old son dies from rationing his insulin, Pay or Die highlights this devastating struggle to survive while living with diabetes.”
Katie Bone win the “American Ninja Warrior Women’s Championship” — not only claiming the title but a cash prize of $50,000. She donated $5,000 to the Juvenile Diabetes Research Foundation and Pumped NM.
Bone has not only appeared on three iterations of the competition series, but is also a nationally-ranked rock climber.
While not the youngest competitor anymore, she was the shortest standing at 5 foot, 2 inches. She’s been making waves since competing in “American Ninja Warrior Jr.” in 2020.
To train for the event during the pandemic, her father built a ninja course in their backyard.
During that competition, Bone, who was diagnosed with Type 1 diabetes at 11 years old, competed with both her insulin pump and glucose monitor on her arms.
Being on the show also presents Bone with the opportunity to be an ambassador for Type 1 diabetes awareness and representation.
Bone says Type 1 diabetes didn’t end her life, it just changed it.
“I hope I inspire a little kid to wear their pump on their arm,” Bone said. “It makes everything that you do that more amazing.”
In February, Bone competed at the USA National Women’s Team Climbing trials in Austin, Texas.
During her fourth climb, she fell.
“Katie heard four pops,” Tammy Bone said. “She tore her ACL and both sides of her meniscus. This was a moment she was preparing for all her life and it got put on pause.”
Bone had surgery and has been getting physical therapy in Colorado. The family returned Monday night to New Mexico after being away for three months.
Bone still has her eyes on the Olympics, though the road to recovery may take some more time.
“I don’t need easy, I just need possible,” she said.
Today LEGO has revealed the first wave of Friends sets for 2023, bringing in a new cast of characters and an update to the branding with a new logo. A new LEGO Friends television series will also accompany the new sets. LEGO’s annual Play Well study revealed that 3 out of 4 children felt there were not enough toys with characters that represent them, so LEGO is aiming to bring more diverse representation to Heartlake City that’s inclusive of not just various ethnicities and genders, but also disabilities and neurodivergence. LEGO says the 2023 sets and series will feature characters with limb difference, Downs Syndrome, anxiety, vitiligo, and even pets with disabilities, including a blind dog and a dog with a wheelchair. She has a CGM printed on her arm and even has a printed phone tile showing her blood sugar. Her name is Hannah and she’s in 41744 Sports Center
On the podcast next week.. Beta Bionics CEO Sean Saint. Last week I MedT 780G
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.