In the News... New islets study, Tzield for babies, MiniMed Go approved, Civica insulin launched, and more!

It's In the News... the top diabetes stories and headlines happening now! Top stories this week include: new islet encapsulation trial, FDA agrees to review Tzield for babies and approves the MiniMed Go, Civica releases it's version of Lantus, Eversense launches with a pump partner, scholarship for college students with diabetes and more!

Announcing Community Commericals! Learn how to  get your message on the show here.

Learn more about  studies and research at Thrivable here

Please visit our Sponsors & Partners - they help make the show possible!

Learn more about  Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com)

Omnipod - Simplify Life

All about Dexcom 

Screen it Like You Mean It

All about VIVI Cap to protect your insulin from extreme temperatures

The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here

Here's where to find us:
Facebook (Group)
Facebook (Page)
Instagram
Check out Stacey's books!

Learn more about everything at our home page www.diabetes-connections.com 

Episode transcript:

Welcome!

This is an In the News episode.. we’re doing things a little differently this year, but we are still bringing you the top diabetes stories and headlines happening now.

We are rotating these shorter episodes with our longer, interview episodes.. but all on Tuesdays now. And that’s why you’ll hear ads on the in the news episodes. My usual disclaimer – we believe in the products advertised here but no one tells me what stories to run or what to say – the commercials are separate from the news. I know most podcasters don’t do disclaimers anymore, but I come from traditional broadcasting and it’s still important to me.

Okay.. our top story this week:

XX

Positive results for a phase 1 clinical trial of encapsulated islets in people with type 1 from Encellin. This first-in-human trial is assessing (1) safety and adverse events, (2) cell survival within the device, and (3) fibrosis, or scarring, around the implants.

As planned, ENCRT devices were removed from the initial five participants after 4 months of implantation. Analysis of the removed devices show:

minimal to no fibrosis (formation of scar tissue around the device);

robust formation of blood vessels around the device;

viable islets inside the device.

These results indicate that the device has the potential to host islet cells while maintaining sufficient oxygen and nutrient flow for the cells to work effectively.

Breakthrough T1D’s Role:

Encellin’s technology was originally developed within the Lab of Dr. Tejal Desai (University of California San Francisco) with funding from Breakthrough T1D, which was crucial in the formation of Encellin as a company and attracting subsequent venture capital.

https://breakthrought1d.ca/cell-therapy-trial-encellins-device-delivers-promising-early-results/

XX

The US Food and Drug Administration has accepted Tzield for priority review to expand the current age indication from eight years and above, to as young as one year old and above to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D.

The target action date for the FDA decision is April 29, 2026.

 

“This priority review emphasizes the urgent need for innovative therapies like Tzield which has the potential to prevent the natural progression of T1D by delaying the loss of endogenous insulin production. This might be particularly significant in this young population, as it is well documented that the autoimmune attack that drives this disease in many cases, begins, early in life,” said Christopher Corsico, Global Head of Development at Sanofi. “If approved, Tzield could represent an important advance for delaying the onset of stage 3 type 1 diabetes in early childhood, which would benefit patients and caregivers alike.”

 

Interim data for the PETITE-T1D phase 4 study was presented at the 51st Annual Conference of the International Society for Pediatric and Adolescent Diabetes and simultaneously published in Diabetologia.

 

Priority review is given to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

 

The safety and efficacy of Tzield in the PETITE-T1D population has not been approved by any regulatory authority.

https://www.globenewswire.com/news-release/2026/01/05/3212420/0/en/Press-Release-Sanofi-s-Tzield-accepted-for-priority-review-in-the-US-for-young-children-with-stage-2-type-1-diabetes.html

XX

Sanofi said the U.S. Food and Drug Administration accepted a priority review to potentially expand the current age range for its Tzield type-1 diabetes drug to include children as young as one year old.

 

The French pharmaceutical company said Monday that the FDA’s review could amend the lower end of the range for the drug, which is currently approved for children as young as eight years old.

Tzield would be the first disease-modifying therapy that works to delay stage three type-1 diabetes for children aged one and older—who currently have stage two of the disease, according to Sanofi.

 

The review comes after positive data from a Phase 4 study, and the anticipated action date for the FDA decision is April 29, Sanofi said.

https://finance.yahoo.com/news/sanofi-says-fda-agrees-review-064000083.html

 

Separately, The European Commission approved Sanofi's Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and paediatric patients eight years of age and older with stage 2 disease, the company announced Monday. A positive opinion had been issued by the EMA's Committee for Medicinal Products for Human Use in November.

https://firstwordpharma.com/story/7057996

 

XX

The FDA clears the MiniMed Go app for multiple daily injections (MDI).

MiniMed Go, a smart MDI system, integrates the InPen smart insulin pen with the Instinct sensor made by Abbott.

Medtronic and Abbott entered a collaboration in August 2024 to pair insulin delivery and continuous glucose monitoring (CGM) technologies. Medtronic (soon to be a standalone company called MiniMed) launched the MiniMed 780G automated insulin delivery system with the Instinct sensor made by Abbott late last year.

Now, the technology can pair with Medtronic’s other insulin delivery offering, the InPen smart insulin pen. MiniMed Go received clearance for individuals with insulin-requiring type 1 and type 2 diabetes aged seven years and older. It also received the nod for children aged 2-6 under the supervision of an adult caregiver. Compatibility for Medtronic’s own Simplera sensor with MiniMed Go remains under FDA review.

Medtronic expects to launch MiniMed Go in the U.S. in the coming spring.

https://www.drugdeliverybusiness.com/medtronic-fda-clearance-minimed-go-inpen-instinct/

XX

A new UNC-led study, published in the Journal of Diabetes and Its Complications, is the first to highlight diabetes distress that people over the age of 65 can encounter when managing T1D, including the unique stressors in this age group. While the researchers found that markedly elevated levels of diabetes distress were less prevalent among older adults than in younger age groups, understanding the sources of that distress – and the people most likely to experience it – will help health care and public health experts improve treatment strategies for this unique population.

Around 36% of older adults surveyed in the study reported elevated levels of diabetes distress warranting further assessment and treatment. Older adults who identified as women, had higher hemoglobin A1C levels and had been to the emergency room in the past year were most likely to experience elevated levels of diabetes distress. The most common stressors included financial worries, T1D management difficulties and worries about complications.  An unexpected finding was that people who had been diagnosed with T1D at earlier ages or had lived with the condition the longest had lower levels of diabetes distress.

 

“Our group hopes to continue exploring the specific factors and experiences that contribute to diabetes distress in this population, and this study has highlighted areas for potential next steps. This work also closely aligns with ongoing projects our research team is conducting, including a clinical trial, ChargeUp.”

https://sph.unc.edu/sph-news/new-study-highlights-stressors-of-living-with-type-1-diabetes-as-an-older-adult/

 

XX

The FDA announced its plan to stop subjecting non-medical grade wearable devices to FDA regulations in an effort to clarify the agency’s approach on AI and digital health.

The guidance builds on the agency’s existing policy classifying low-risk wellness tools, such as fitness apps and activity trackers encouraging exercise, as non-medical devices exempt from tight regulation, provided they don’t associate claims related to disease diagnosis or treatment.

When asked about the accuracy of these general wellness devices Makary told Fox News, "If they're not making claims that they are medical grade, let's let the market decide. Let's let doctors choose from a competitive marketplace which ones they recommend for their patients.”

I’m watching this closely, curious to see which will be the first diabetes related product through the gate.

General Wellness: Policy for Low Risk Devices U.S. Food and Drug Association January 6, 2026https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices

https://www.pharmexec.com/view/fda-limits-regulations-non-medical-grade-wearable-fitness-devices

XX

Senseonics announced today that it began the launch of its Eversense 365 sensor with the Sequel Med Tech twiist pump. This is the first pump pairing with the implantable one-year CGM.

The system features what they’re calling iiSure technology, which includes four checkpoints to provide accurate delivery and alert users to blockages quickly. Cleared for ages six and up with type 1 diabetes, it offers a personalized way to manage the condition. Sequel began its rollout for the AID system in 2025.

 

https://www.drugdeliverybusiness.com/senseonics-sequel-launch-eversense-365-twiist/

XX

Interesting study testing GIP in men with type 1. You’ve heard of GIP – it’s in drugs like terzepatide along with GLP-1, these are hormones for blood sugar control and weight loss. These Danish researchers tested whether giving a GIP intraveneoiusly would level out blood sugar after meals in settings that put the men at high risk for low blood sugar, like exercise. It did not prevent lows.. but it did reduce peak glucose levels after meals.

https://www.medscape.com/viewarticle/gip-reduces-meal-peaks-not-hypoglycaemia-t1d-2026a10000bx

 

XX

Nearly 3 years after Breakthrough T1D joined forces with Civica, a non-profit pharmaceutical company, its first insulin is now available for purchase at pharmacies across the country.

This is a long acting insulin interchangeable with Lantus.

Called Civica insulin glargine-yfgn. It will have a “CalRx” label in California.

Max recommended price: $55 per box of five pens. Your cost may be lower depending on insurance. This is the lowest list price for long-acting insulin, without hidden rebates or markups.

Yes. If you already have a prescription for insulin glargine (e.g., Lantus), you do not need a new one because Civica insulin glargine-yfgn is interchangeable. Confirm with your provider and pharmacist.

https://www.breakthrought1d.org/news-and-updates/civicas-affordable-long-acting-insulin-now-available/

XX

https://www.healthline.com/health-news/coffee-may-improve-heart-health-lower-diabetes-risk

A familiar name to many of you starts a new venture.. that’s right after this:

AD #2

Dexcom

 

XX

Interesting news from a power player in diabetes. Marie Schiller announced a new resource for the diabetes community – a company called Locasana and a consumer brand called Health Sites. Schiller wrote on LinkedIn that she’ll be CEO of the company that seeks to development an at-home diagnostic concept to assess tissue and skin health. Healthy Sites, a consumer brand dedicated to helping people care for their skin before, during, and after therapy. Many people struggle with issues like “pump bumps,” redness, bruising, scarring, and irritation, and have had few product-level solutions available to them.

Schiller co-founded the T1D Exchange and served as Vice President, Connected Care and Insulin Product Development and Site Head, Cambridge Innovation Center at Eli Lilly. She’s lived with type 1 for more than 40 years.


XX

Very sorry to hear about the death of David Mitchell, the founder of Patients for Affordable Drugs. Mitchell died on January 2^nd. Patients For Affordable Drugs, founded in 2016,  is the only national patient advocacy organization focused exclusively on policies that lower prescription drug prices.

I spoke with David Mitchell and Lauren Stanford about the organization and the legislation they were urging should pass at the time, back in 2020. I’m going to link that interview up in the show notes – our conversation starts about five minutes in. I did not know David personally, but in our conversation and in everything I read, he was practical, passionate and hopeful. Patients for Affordable drugs has had some big victories, and their work will go on.

To learn more, visit PatientsForAffordableDrugs.org.

https://diabetes-connections.com/minisode-7-spare-a-rose-what-can-we-do-about-the-price-of-insulin/

XX

New scholarship for college students with type 1 is open for entrants! The MannKind Al Mann Centennial Scholarship seeks to empower young adults with diabetes to pursue their dreams in the life sciences.

Any incoming Any incoming freshman or current undergraduate student who is between the ages of eighteen and twenty-two may apply for this scholarship opportunity if they are living with type 1 or 2 diabetes and if they are pursuing life sciences or a related field. Applicants must be motivated to make a meaningful impact in the diabetes sector and community.

All the info in the show notes.

https://bold.org/scholarships/mannkind-al-mann-centennial-scholarship/

--