In the News...Tandem's new infusion set approved, Sernova cell-pouch moves forward, GLP-1 meds for T1D, and more!

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Tandem's new infusion set is approved, Dexcom G7 compatibility with the Omnipod 5 iPhone app announced, Sernova cell-pouch moves forward, GLP-1 meds for T1D, and more!

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Episode transcription with links:

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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Tandem gets FDA clearance for a new infusion set. The company shared in an SEC filing that its Capillary Biomedical (CapBio) subsidiary won clearance for its SteadiSet Infusion Set.

SteadiSet features an integrated inserter with a hidden needle designed for one-handed insertion. It received clearance to deliver insulin for up to three days of use. However, Tandem plans to submit a separate request to extend the indicated use time to up to seven days. It doesn’t expect to begin commercial activities for SteadiSet until after it receives clearance for the extended use time.

Many of us have been following this since Tandem acquired CapBio back in 2022.. it’s been pretty hush hush – CapBio has never accepted my requests for interviews, so I’m excited to see this approval, mostly because my son really really needs it!

https://www.drugdeliverybusiness.com/tandem-capbio-fda-clearance-insulin-infusion-set/

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Insulet just announced via an email to health care providers that Dexcom G7 compatibility with the Omnipod 5 iPhone app will be released IN THE COMING WEEKS! Great news for people with #t1d and

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Sernova announces positive interim data from its ongoing Phase 1/2 clinical trial in patients with T1D. this is their Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today

Interim data from 12 patients with transplanted human donor islet cells show patients achieving insulin independence, islet cell engraftment in Cell Pouch, islet function, islet survival, improved glycemic control, improved patient reported quality of life (QOL) and improved awareness of hypoglycemia and increased sensitivity to severe hypoglycemic symptoms. Improvement in patient outcomes was correlated with a cumulative increase in the quantity of transplanted islets. Based on these findings, the study is on track to meet its primary and secondary endpoints, and the confirmatory Cohort C is expected to initiate in H2 2025.

 

Clinical trials with iPSC islet-like clusters from Sernova’s partner, Evotec, are anticipated to begin in 2026 after completion of Cohort C of the ongoing trial. These interim findings, with 8 of 12 patients achieving insulin independence so far, support the thesis that Sernova’s high volume ten channel Cell Pouch, used in Cohort B, plus an optimised immune suppression regimen, has the potential to achieve insulin independence, without portal vein transplant, in our planned clinical trial with Evotec’s high quality iPSC islet-like clusters.

Measured HbA1c (a blood test that shows the average blood sugar levels over the past 2-3 months) in patients with Cell Pouch alone, showed that 9 of 12 patients had a reduced value within the American Diabetes Association (ADA) recommended range of <7.0%. Of the remaining 3 patients, 1 experienced a 24% reduction in HbA1c from 10.3% to 7.8% and the other 2 maintained a normal HbA1c value of <7% as measured at baseline. Published clinical studies found that each 1% reduction in A1c was associated with a 14 % reduced risk of myocardial infarction. A single portal vein transplant resulted in all Patients having a recommended HbA1c of <7.0% that was maintained for the duration of the study.

 

https://sernova.com/press_releases/sernova-biotherapeutics-provides-positive-interim-data-from-ongoing-phase-1-2-clinical-trial-of-cell-pouch-bio-hybrid-organ-in-patients-living-with-type-1-diabetes/

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A new study in the European Heart Journal shows that people who develop type 1 diabetes in adulthood have an increased risk of cardiovascular disease and death, and that those diagnosed later in life do not have a better prognosis than those diagnosed earlier. But the study points to smoking, poor glucose control and obesity as the main risk factors.

 

The registry-based study identified 10,184 people diagnosed with type 1 diabetes in adulthood between 2001 and 2020 and compared them to 509,172 matched people in the control group.

The study shows that these people with adult-onset type 1 diabetes had a higher risk of cardiovascular disease and death from all causes, including cancer and infections, compared to the control group.

"The main reasons for the poor prognosis are smoking, overweight/obesity and poor glucose control. We found that they were less likely to use assistive devices, such as insulin pumps,"

"But we show that the prognosis can be significantly improved by preventing smoking and obesity and improving glucose control, not least in people diagnosed at older ages," explains senior author Sofia Carlsson, senior lecturer and associate professor at the same department.

 

The researchers plan to continue investigating adult-onset type 1 diabetes, including risk factors for developing the disease and the prognosis of other outcomes, such as microvascular complications. Optimal treatment in adult-onset type 1 diabetes, including the effect of pump use and other advanced technologies, also needs to be explored.

https://medicalxpress.com/news/2025-05-adult-onset-diabetes-cardiovascular-disease.html

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Breakthrough T1D, the leading global type 1 diabetes (T1D) research and advocacy organization, today announced the publication of two peer-reviewed journal articles that expand insight into the burdens of living with T1D in 2025. The papers shine a much-needed light on the burdens facing people who live with this lifelong, demanding disease that causes the pancreas to make very little insulin or none at all, and the immediate need to accelerate life-saving cures for T1D through cell therapy.

 

Authored by a team of Breakthrough T1D executives, including CEO Aaron J. Kowalski, PhD,  "The Urgent Need for Breakthrough Therapies and a World Without Type 1 Diabetes", published in Diabetes Therapy, challenges the misperception that insulin therapy and today's diabetes technologies are meeting the needs of people with T1D. The paper stresses that although progress has been made in managing T1D, the disease still results in premature death, significant complications and a substantial daily burden for those affected by it. It argues that accelerating cell therapies which restore the body's ability to produce its own insulin are key to T1D cures.

 

The Breakthrough T1D authors emphasize the need for the entire T1D community, including researchers, regulators, policymakers, and people living with T1D to work together to hasten the development of novel T1D therapies.

 

The second paper, "We Are on the Verge of Breakthrough Cures for Type 1 Diabetes, but Who Are the 2 Million Americans Who Have It?", published in the Journal of Health Economics and Outcomes Research, shares valuable demographic information on the broad spectrum of Americans living with T1D and predicts the changes this population will undergo in the next decade. Once viewed as a condition that could only be diagnosed in childhood, it is now known that T1D can develop at any age.

https://www.prnewswire.com/news-releases/breakthrough-t1d-announces-the-publication-of-two-peer-reviewed-articles-that-expand-insight-into-the-burdens-of-living-with-type-1-diabetes-302453489.html

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Experts are also interested in other uses of semaglutide. A recent study published in The New England Journal of Medicine furthered research on semaglutide, exploring how the drug affected outcomes for people with metabolic dysfunction-associated steatohepatitis, a type of liver disease.

 

The results suggest that semaglutide may help resolve steatohepatitis and decrease fibrosis.

 

 

Semaglutide improves liver outcomes

This research was a phase 3 clinical trial involving people with metabolic dysfunction-associated steatohepatitis (MASH). As described in this study, MASH is a severe type of what used to be called nonalcoholic fatty liver disease.

 

The study also notes that MASH involves damage to liver cells, inflammation, and steatosis or fat buildup in the liver. Steatohepatitis, which involves fat buildup and inflammation in the liver, can then contribute to tissue scarring or fibrosis.

 

This study involved participants from hundreds of clinical sites in thirty-seven countries. The current published results report the end of the first part of the trial.

 

https://www.medicalnewstoday.com/articles/diabetes-weight-loss-drug-semaglutide-ozempic-may-also-treat-liver-disease

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For the first time, researchers are exploring the effectiveness of tirzepatide – which is currently only approved for type 2 diabetes – for people with type 1 diabetes and obesity or overweight.

 

Trial status: Recruiting

 

Clinical Trials Identifier: NCT06914895

 

Trial Name: A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight (SURPASS-T1D-1)

 

Diabetes Type: Type 1 diabetes

 

Trial Sponsor: Eli Lilly

 

Why is this study important?

GLP-1 medications have traditionally been off-limits for people with type 1 diabetes due to concerns around risks like hypoglycemia and diabetic ketoacidosis (DKA). That may change with a new study – the first-of-its-kind – testing tirzepatide in people with type 1 diabetes and obesity or overweight.

 

Tirzepatide is a GLP-1/GIP therapy currently FDA-approved for weight management (Zepbound), type 2 diabetes (Mounjaro), and sleep apnea. Research indicates the same benefits drugs like tirzepatide have for type 2 diabetes – improved blood sugar levels, increased time in range, and proven benefits for both the heart and kidneys – would likely extend to people with type 1.

 

This study represents a first step towards a monumental win for the type 1 community. If successful, tirzepatide could become the first GLP-1/GIP therapy approved for type 1 diabetes.

 

How does the trial work?

Participants will be randomly assigned to one of four tirzepatide dosing groups or the placebo group. Those assigned to a treatment group will receive a once-weekly subcutaneous injection of tirzepatide while the other group will receive a weekly placebo injection. The study will last about 49 weeks and may include up to 23 visits.

 

To determine the safety and effectiveness of tirzepatide, researchers will measure changes in A1C, time in range, body weight, blood pressure, and cholesterol.

 

Are you interested in participating?

You may be eligible to participate if you are 18 years or older and have:

 

Type 1 diabetes and have been on insulin for at least one year prior to screening

An A1C of 7% to 10.5% at screening

A body mass index of 25 or higher at screening

Stable weight for at least 90 days prior to screening and agree not to start an intensive diet or exercise program during the study

People who have had two or more hospitalizations for hyperglycemia or DKA in the past six months, have had one or more emergency treatments for severe hypoglycemia in the past three months, or are receiving treatment for diabetic retinopathy or macular edema are not eligible to participate in this study. See a full list of inclusion/exclusion criteria here.

 

This trial is currently recruiting in multiple locations worldwide. To enroll or learn more about this study, contact [email protected] or call 1-877-285-4559.

https://diatribe.org/diabetes-research/groundbreaking-trial-testing-tirzepatide-type-1-diabetes

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Roche Diagnostics will build a $550 million expansion to produce continuous glucose monitors at an Indianapolis facility. Roche will use the site to make its Accu-Chek Smartguide devices, which launched last year in Europe as the company’s first CGM.

 

The Indianapolis site is Roche Diagnostics’ North American headquarters. It houses research and development, laboratories, manufacturing and other functions, and produces Roche’s Accu-Chek diabetes test strips. The facility is one of two global distribution hubs for the company.

Roche received a CE Mark in July for its Accu-Chek Smartguide CGM. The device, which can be worn for 14 days, incorporates predictive algorithms to estimate users’ glucose levels over two hours and nocturnal hypoglycemia risk. However, users must calibrate the CGM using a finger stick, which some newer devices from Abbott and Dexcom don’t require.

https://www.medtechdive.com/news/roche-manufacturing-indiana-cgm/747809/

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Excited to see Go Pen receive FDA approval- an inspiring journey from wining our innagrial American Diabetes Association Innovation Challenge to helping people with diabetes .

They solve the challenge faced by the 13 million people worldwide living with diabetes who don’t have access to insulin pens for their daily injections.
Instead, they use a disposable syringes with all the inherent inaccuracies

A low cost global option to convert vial to reusable insulin pen use

Inspired leadership from the caring Ole Kjerkegaard Nielsen and team.

This is how hashtag#startUps can meet unmet needs of people with hashtag#diabetes
https://www.go-pen.com

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https://www.liebertpub.com/doi/10.1089/dia.2025.0169

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Ascensia announces that Eversense 365 has been named the Best New Technology Solution for Diabetes Management in the 2025 annual MedTech Breakthrough Awards Program. This follows a Gold award at the last month’s Edison Best New Products Awards, where Eversense beat Abbot’s Lingo CGM.

 

• Eversense 365 is the only long-term CGM system available, offering people with diabetes a truly differentiated CGM experience, providing one year of exceptionally accurate monitoring with minimal interruptions.

 

• The tiny implantable sensor and unique approach to CGM also allows people to overcome common frustrations and interruptions experienced with traditional short-term CGMs, so they can focus on managing their diabetes and not their device.

 

• Eversense 365 is currently available in the US and indicated for people with diabetes 18 years and older; an application for European CE Mark registration has been filed to allow Eversense 365 to be marketed in Europe.

 

• Eversense 365 has also recently partnered with Sequel Med Tech to create the first automated insulin delivery system with a one-year CGM. The integrated system is expected to launch in Q3 of 2025.

 

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Front office change at Dexcom.. Jake Leach, who joined Dexcom in 2004 to lead the development of sensor electronics for its first commercial CGM system, now has a new title.

Leach, who became the company's COO in 2022, is now president and COO at the San Diego-based company. As COO, he provides end-to-end responsibility for product development and oversight of executive leadership functions.Now, as president on top of that, he takes on the additional responsibility of overseeing corporate development and strategy efforts at Dexcom.

Full story here: https://lnkd.in/eRzpR_Rd

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