It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sanofi lowers prices, oral pill for T1D prevention studied, updates from Medtronic, Tandem, and Sequel Med Tech, falsely lower A1Cs (and why that happens), Biolinq gets FDA okay for micro-needle CGM and more!

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Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.

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French drugmaker Sanofi says it would offer a month's supply of any of its insulin products for $35 to all patients in the U.S. with a valid prescription, regardless of insurance status.

The program, originally meant for uninsured diabetes patients, would now include those with commercial insurance or Medicare, the drugmaker said.

Patients will be able to purchase any combination, type, and quantity of Sanofi insulins with a valid prescription for the fixed monthly price of $35, starting January 1.

Lilly and Novo also have similar programs through which they offer insulin products for $35 a month for U.S. patients regardless of whether the patients have insurance.

There is no law at work here – the only legislation that has changed the price of insulin came with the Inflation Reduction Act in 2022 with the Medicare cap. Helping lower the cost here, biosimilars hitting the market and the huge profitability for GLP-1 drugs for Novo and Lilly

https://www.reuters.com/business/healthcare-pharmaceuticals/sanofi-offer-all-insulin-products-35-per-month-us-2025-09-26/

XX

A pill typically prescribed for rheumatoid arthritis and alopecia might help slow the progression of type 1 diabetes, a new study says. Baricitinib (bare-uh-SIT-nib) safely preserved the body's own insulin production in people newly diagnosed with type 1 diabetes.. and their diabetes started progressing once they stopped taking baricitinib, results show. They produced less insulin and had less stable blood sugar levels.

 

Baricitinib works by quelling signals in the body that spur on the immune system, and is already approved for treating autoimmune conditions such as rheumatoid arthritis, ulcerative colitis and alopecia, researchers said.

 

"Among the promising agents shown to preserve beta cell function in type 1 diabetes, baricitinib stands out because it can be taken orally, is well tolerated, including by young children, and is clearly efficacious," Waibel said.

"We are hopeful that larger phase III trials with baricitinib are going to commence soon, in people with recently diagnosed type 1 diabetes as well as in earlier stages to delay insulin dependence," she added. "If these trials are successful, the drug could be approved for type 1 diabetes treatment within five years."

 

Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.

 

https://www.usnews.com/news/health-news/articles/2025-09-23/pill-effective-in-slowing-type-1-diabetes-progression

XX

An existing transplant drug has shown promise in slowing the progression of type 1 diabetes in newly diagnosed young people, potentially paving the way for the first therapy that modifies the disease after diagnosis.

The Drug, called ATG, is currently used together with other medicines to prevent and treat the body from rejecting a kidney transplant. It can also be used to treat rejection following transplantation of other organs, such as hearts, gastrointestinal organs, or lungs.

The researchers studied 117 people aged five to 25, who'd been diagnosed with type 1 diabetes within the past three to nine weeks. The participants were from 14 centers across eight European countries and were randomized to be given different doses of ATG (0.1, 0.5, 1.5, or 2.5 mg/kg) or a placebo. ATG was given as a two-day intravenous (IV) infusion. The main goal was to see how well the pancreas could still make insulin after 12 months, measured by C-peptide levels during a special meal test. C-peptide is released into the blood along with insulin by the pancreas.

 

The findings are promising, showing that ATG, even at a relatively low dose, can slow the loss of insulin-producing cells in young people newly diagnosed with type 1 diabetes. The lower dose also caused fewer side effects, making it a more practical option.

https://newatlas.com/disease/antithymocyte-globulin-newly-diagnosed-type-1-diabetes/

 

 

XX

The FDA has delayed its feedback on Lexicon Pharmaceuticals' application to bring Zynquista (sotagliflozin) to people with type 1 diabetes. The agency had planned to respond this month but will now wait until the fourth quarter after reviewing new data from ongoing studies.

Zynquista, an oral drug meant to be used with insulin, has already been approved for heart failure (marketed as Inpefa). But in type 1 diabetes, it faces safety concerns: last year an FDA advisory committee voted 11–3 that its benefits don't outweigh the increased risk of diabetic ketoacidosis (DKA). The FDA later issued a complete response letter rejecting the drug.

Lexicon is still pushing forward, hoping its additional submissions will strengthen Zynquista's case for type 1 diabetes approval.

https://www.biospace.com/fda/after-fda-rejection-lexicons-type-1-diabetes-drug-hit-with-another-regulatory-delay

 

 

XX

A common but often undiagnosed genetic condition may be causing delays in type 2 diabetes diagnoses and increasing the risk of serious complications for thousands of Black and South Asian men in the UK—and potentially millions worldwide.

A new study found around one in seven Black and one in 63 South Asian men in the UK carry a genetic variant known as G6PD deficiency. Men with G6PD deficiency are, on average, diagnosed with type 2 diabetes four years later than those without the gene variant. But despite this, fewer than one in 50 have been diagnosed with the condition.

 

G6PD deficiency does not cause diabetes, but it makes the widely used HbA1c blood test—which diagnoses and monitors diabetes—appear artificially low. This can mislead doctors and patients, resulting in delayed diabetes diagnosis and treatment.

 

The study found men with G6PD deficiency are at a 37% higher risk of developing diabetes-related microvascular complications, such as eye, kidney, and nerve damage, compared to other men with diabetes.

 

"This study highlights important evidence that must be used to tackle these health inequalities and improve outcomes for Black communities. Preventative measures are now needed to ensure that Black people, especially men, are not underdiagnosed or diagnosed too late."

https://medicalxpress.com/news/2025-09-hidden-genetic-delay-diabetes-diagnosis.html

XX

Novo Nordisk today announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Awiqli® (insulin icodec) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the United States, providing an alternative to daily basal insulin injections for adults living with type 2 diabetes.

 

The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® which is comprised of five randomized, active-controlled, treat-to-target clinical trials in approximately 4,000 adults with type 2 diabetes. The clinical program evaluated Awiqli® vs. daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.1-5

Awiqli® is approved in the EU, along with 12 additional countries. In addition, regulatory filings have been completed in several other countries, with further regulatory decisions expected in 2025.

XX

Interesting news from Sequel Med Tech – they've signed an agreement with Arecor to pair the twiist pump with AT278 an ultra-concentrated (500U/mL), ultra-rapid insulin in development.

They also have a deal with Medtronic to develop insulin for new pumps.

This insulin isn't yet approved, it's 5 times stronger than standard fast acting  it's hoped that a clinical study will begin next year.

Arecor says its insulin could potentially be the only option capable of enabling and catalyzing the next generation of longer-wear and miniaturized automated insulin delivery systems.

 

https://www.drugdeliverybusiness.com/sequel-arecor-develop-rapid-insulin-twiist/

XX

Tandem Diabetes Care announes its t:slim X2™ insulin pump with Control-IQ+ automated insulin delivery (AID) technology is now cleared for use with Eli Lilly and Company's Lyumjev® (insulin lispro-aabc injection) ultra-rapid acting insulin in the United States (U.S.).

 

– The t:slim X2 insulin pump with Control-IQ+ technology is now cleared for use with Lyumjev for people with type 1 diabetes ages 2 and above and all adults with type 2 diabetes.

The companies are continuing to work toward securing Lyumjev compatibility for the Tandem Mobi pump.

https://hitconsultant.net/2025/09/29/tandem-diabetes-cares-tslim-x2-pump-cleared-for-use-with-lillys-ultra-rapid-lyumjev-insulin/

XX

You can now place your order for the MiniMed™ 780G system with the Instinct sensor, made by Abbott. And if you are already a MiniMed 780G user, you can place an upgrade order today. ​This is a 15 day wear sensor, with no transmitter or overtape required. It looks the same at other Abbot sensors such as the Libre but is proprietary to Medtronic. Shipments are scheduled to start in November.

 

​ https://www.drugdeliverybusiness.com/medtronic-launches-minimed-780g-instinct-abbott/

 

XX

The global type 1 diabetes (T1D) burden continues to increase rapidly driven by rising cases, ageing populations, improved diagnosis and falling death rates. ,

 

The study estimates that T1D will affect 9.5 million people globally in 2025 (up by 13% since 2021), and this number is predicted to rise to 14.7 million in 2040. However, due to lack of diagnosis and challenges in collecting sufficient data, the actual number of individuals living with T1D is likely much higher, researchers say.

 

In fact, they estimate that there are an additional 4.1 million 'missing people' who would have been alive in 2025 if they hadn't died prematurely from poor T1D care, including an estimated 669,000 who were not diagnosed. This is particularly true in India, where an estimated 159,000 people thought to have died from missed diagnoses.

The study predicts that 513,000 new cases of T1D will be diagnosed worldwide in 2025, of which 43% (222,000) will be people younger than 20 years old. Finland is projected to have the highest incidence of T1D in children aged 0-14 years in 2025 at around 64 cases per 100,000.

The substantial increases in T1D forecasts between 2025 and 2040 underscore the urgent need for action. As co-author Renza Scibilia from Breakthrough T1D explains, "Early diagnosis, access to insulin and diabetes supplies, and proper healthcare can bring enormous benefits, with the potential to save millions of lives in the coming decades by ensuring universal access to insulin and improving the rate of diagnosis in all countries."

 

The authors note some important limitations to their estimates, including that while the analysis uses the best available data, predictions are constrained by the lack of accurate data in most countries-highlighting the urgent need for increased surveillance and research. They also note that data on misdiagnosis and adult populations remain limited, and the analysis assumes constant age-specific incidence and mortality over time. Furthermore, incidence data from the COVID-19 period were excluded from part of the modelling to avoid bias. Future updates are expected to improve as new data become available and applied.

https://www.news-medical.net/news/20250919/New-study-warns-of-millions-of-undiagnosed-and-missing-people-with-type-1-diabetes.aspx

XX

A new study has found that semaglutide — the active ingredient found in some GLP-1 medications prescribed for diabetes and to aid weight loss — may help protect the eyes from diabetic retinopathy.

Researchers estimate that as much as 40% of all people with diabetes also have diabetic retinopathy — a potentially blinding eye condition caused by blood vessel damage in the eye's retina.

There is currently no cure for diabetic retinopathy. The condition is often managed through injections of anti-VEGF medications into the eye, surgery, and blood sugar monitoring and control.

For this lab-based study, researchers used samples of human retinal endothelial cells that were treated with different concentrations of semaglutide. The cells were then placed in a solution with both a high glucose level and high level of oxidative stress — where there is an imbalance of antioxidants and free radicals — for 24 hours.

 

Past studies show that oxidative stress plays a role in the formation of diabetic retinopathy.

 

At the study's conclusion, researchers found that the retinal cells treated with semaglutide were twice as likely to survive than cells that were untreated. Additionally, the treated cells were found to have larger stores of energy.

 

Scientists also found that three markers of diabetic retinopathy were decreased in the semaglutide-treated retinal cells. First, the levels of apoptosis — a form of cell death — decreased from about 50% in untreated cells to about 10% in semaglutide-treated cells. The production of the free radical mitochondrial superoxide decreased from about 90% to about 10% in the treated retinal cells.

 

Researchers also found the amount of advanced glycation end-products — harmful compounds that can collect in people with diabetes and are known to cause oxidative stress — also decreased substantially.

 

Lastly, scientists reported that the genes involved in the production of antioxidants were more active in the semaglutide-treated cells when compared to untreated cells. Researchers believe this is a sign that semaglutide may help repair damage to the retinal cells.

 

"Our study did not find that these drugs harmed the retinal cells in any way — instead, it suggests that GLP1-receptor agonists protect against diabetic retinopathy, particularly in the early stages," Ioanna Anastasiou, PhD, molecular biologist and postdoctoral researcher at the National and Kapodistrian University in Greece, and lead author of this study, said in a press release.

 

"Excitingly, these drugs may be able to repair damage that has already been done and so improve sight. Clinical trials are now needed to confirm these protective effects in patients and explore whether GLP-1 receptor agonists can slow, or even halt, the progression of this vision-robbing condition."

https://www.medicalnewstoday.com/articles/ozempic-semaglutide-may-help-protect-against-diabetes-related-blindness-retinopathy

 

XX

Biolinq has received De Novo Classification from the U.S. Food and Drug Administration for its lead product, Biolinq Shine, a patch on the forearm that provides real-time glucose feedback through a primary color-coded LED display, visible with or without a phone.

This one is tricky – it's called a needle free CGM but it also says it uses micro needles.

By the way, De Novo isn't exactly the same as what we think of for FDA approval for medical devices. It's not as rigorous but it's a streamlined route for novel, low to moderate risk devices with no existing equivalent.

We'll see how this one turns out.

https://www.hmenews.com/article/biolinq-s-multi-function-biosensor-receives-fda-de-novo-classification