In this week’s issue of The Savvy Diabetic:
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- Sequel/Twiist & Abbott’s Future Dual Glucose/Ketone Sensor
- Spleen-based islet transplantation restores glycemic control in T1D without full immunosuppression
- Medtronic Spins Off Diabetes Business
- Kakao Healthcare AI-Powered CGM for Japanese Markets
- Elvinix (formerly Levicure) Functional Cure in “Stealth Mode”
- Tandem Diabetes Pays Roche $36M in Patent Infringement Deal
- FDA Removes Hold on vTv’s Cadisegliatin
- FDA OKs Susvimo (Roche) for Diabetic Retinopathy
- May is Mental Health Awareness Month & National Diabetes Month
- Diabetes Mental Health: Understanding Distress, Burnout & Depression by Drs. Edelman & Pettus (video)
- How to Channel Distress Into Something Positive by diaTribe
Sequel Med Tech to Integrate twiist Automated Insulin Delivery System with Abbott’s Future Dual Glucose-Ketone Sensor published by GlobeNewsWire.com, 22 May 2025.
Sequel Med Tech, LLC, a company developing state-of-the-art insulin delivery technologies, announced a commercial development agreement for future integration of Sequel’s twiist™ Automated Insulin Delivery (AID) System powered by Tidepool, with Abbott’s glucose-ketone sensor, currently under development.
The agreement aims to improve outcomes for people with type 1 diabetes by adding ketone sensing capabilities to a Libre glucose sensor in combination with the twiist AID System to enable earlier detection of rising ketones. Regular measurement of ketones has been shown to reduce the risk of diabetic ketoacidosis in people living with type 1 diabetes. Sequel’s expanded integration with Abbott’s sensor underscores the company’s commitment to delivering more choice, flexibility, and confidence to people managing type 1 diabetes.
“By integrating the twiist AID System with Abbott’s future glucose-ketone sensor, Sequel will be able to offer people with diabetes greater choice and the potential for improved outcomes in managing their care. twiist was designed to identify interruptions in insulin delivery rapidly, so combining this with early identification of rising ketones could help people living with diabetes react more quickly and more confidently,” said Sequel CEO and Co-Founder Alan Lotvin, M.D. “Through this collaboration, we are redefining what people living with diabetes can expect from an AID system.”
Spleen-based islet transplantation restores glycemic control in type 1 diabetes without full immunosuppression by Justin Jackson for MedicalXPress.com, 26 May 2025.
In type 1 diabetes, the immune system destroys native beta cells, the insulin-producing cells housed within pancreatic clusters called islets of Langerhans. Islet transplantation transfers these clusters from donor pancreases into the portal vein of the recipient’s liver, where they settle in the hepatic microvasculature. Once in place, they resume insulin secretion to reduce or eliminate injections and restore glycemic control.
Liver-based transplantation has significant drawbacks. Immune attack, low oxygen tension, and the rigidity of hepatic tissue often destroy most transplanted islets within hours. Up to 70% of cells are destroyed before engraftment, forcing reliance on multiple donors per recipient and blunting therapeutic success. Alternate sites such as the eye, omentum, and striated muscle have been explored, yet each introduces complications ranging from invasive surgery to poor islet survival or abnormal insulin delivery patterns.
In the study, “Islet transplantation in immunomodulatory nanoparticle–remodeled spleens,” published in Science Translational Medicine, Wenzhou Medical University researchers engineered spleens with glucomannan-coated silica nanoparticles to create a vascularized, immunosuppressive environment for transplanted islets. Nanoparticle-driven spleen remodeling allowed transplanted mouse, rat, and human islets to restore normal blood sugar in diabetic rodents and cynomolgus macaques.
Remodeled spleens developed a local immune environment that supported graft tolerance. In mice, nanoparticle treatment expanded regulatory T cells and M2 macrophages while reducing effector T cells and pro-inflammatory cytokines. Grafted islets triggered minimal antibody or cytokine responses, even across species barriers. In macaques, remodeled spleens showed similar immune remodeling, with anti-inflammatory gene expression and dampened T cell activation. Researchers concluded that spleen remodeling offers a viable alternative to liver-based islet transplantation. The engineered microenvironment supported islet survival and function across species with reduced immune intervention.
The approach offers a less invasive, more reliable, less risky method for restoring insulin production in type 1 diabetes. While longer-term studies and clinical trials are still required, initial results look promising as a strategy that could bring islet-based therapies closer to routine clinical use.
MEDTRONIC in the NEWS:
Medtronic plans to spin off diabetes business within 18 months by Ricky Zipp for MedTechDive.com, 21 May 2025.
Medtronic said that it plans to spin off its diabetes business in the next 18 months, creating a new diabetes technology company that can offer customers both insulin pumps and continuous glucose monitors. In the announcement, Medtronic argued that the move would focus the remaining company and create a new, scaled diabetes tech competitor. The company’s “preferred path” is to initiate an initial public offering followed by a full split, creating a stand-alone, publicly traded company.
CEO Geoff Martha told investors the decision is a “win for both companies,” simplifying Medtronic’s portfolio and allowing for focused funding and strategy for the diabetes firm. “For Medtronic, our portfolio becomes more focused on high-margin growth markets like [pulsed field ablation] and renal denervation,” Martha said during an earnings call. “At the same time, the independent new diabetes company will be a scaled leader, and the only diabetes company to commercialize a complete ecosystem to address intensive insulin management.”
Read more: Medtronic plans to spin off diabetes business within 18 months
Why Medtronic plans to spin out its diabetes business by Elise Reuter for MedTechDive.com, 22 May 2025.
“We’re left asking why?” J.P. Morgan analyst Robbie Marcus wrote in a research note. “Why spin off a growth business in one of the best end markets in MedTech?”
Medtronic CEO Geoff Martha said the diabetes business is “well down the path of a turnaround, it’s ready to stand alone, and we think it’s well suited for the public markets.” He added that the change should give the diabetes business the funding and focus it needs to reach its full potential and allow Medtronic to focus on other high-margin businesses, such as pulsed field ablation and renal denervation.
The new diabetes company would be the only one in the market that sells both insulin pumps and glucose sensors. Medtronic expects to conclude the deal, which would involve an initial public offering and a subsequent split-off, within 18 months. Martha said differences in how the diabetes unit operates mean it benefits less from sharing manufacturing and technology platforms with Medtronic’s other segments. The diabetes business primarily sells directly to customers, such as patients or physicians, rather than selling to hospitals or ambulatory surgery centers, as Medtronic’s other segments do, the CEO said. The decision “is a logical one that should provide value for Medtronic, this franchise, and investors over time,”
Read more: Why Medtronic plans to spin out its diabetes business
Kakao Healthcare Expands AI-Powered Glucose Monitoring App to Japanese Market published by Trial.medpath.com, 17 May 2025.
Kakao Healthcare Corp. announced plans to introduce its artificial intelligence-powered continuous glucose monitoring (CGM) application, PASTA, to the Japanese market through a newly established subsidiary. This move represents a significant milestone in the South Korean company’s strategy to expand its global footprint in digital health solutions.The establishment of a Japanese subsidiary signals Kakao Healthcare’s commitment to international growth beyond its South Korean home market. Japan, with its aging population and high adoption rate of digital health technologies, presents a strategic opportunity for CGM-related solutions.
Read more: Kakao Healthcare Expands AI-Powered Glucose Monitoring App to Japanese Market
Elvinix is developing a functional cure for Type 1 Diabetes, but this was NOT announced, as they are currently operating in “Stealth Mode.”
Elvinix is a biotech company co-founded by leading Key Opinion Leaders (KOLs) in the Type 1 Diabetes field, dedicated to developing a functional cure for Type 1 Diabetes. The company is currently operating in stealth mode. “Our disruptive patent-protected therapy is designed to restore the insulin-secretory function of pancreatic islet β-cells.”
All I can find out: Daniil Koshelev is the new (as of 2 months ago) CEO of Elvinix/LeviCure. I’ve shared about Levicure this past year, founded by Dr. Shmuel Levit. Levicure was co-founded by Shmuel Levit, MD, PhD, Daniil Koshelev, and Lucy Kosheleva. Shmuel Levit is an endocrinologist with 35+ years of clinical experience, Daniil Koshelev is an experienced CEO, and Lucy Kosheleva has 12 years of experience in legal and investor relations.
Tandem Diabetes Agrees to Pay Roche $36M in Patent Infringement Deal by Katherine Hamilton for MarketWatch.com, 23 May 2025.
Tandem Diabetes Care has agreed to pay Roche Holding $36 million to settle a patent infringement claim. Tandem said that the two companies have granted each other licenses to patent the insulin delivery systems in question for the next 10 years. The Swiss pharmaceutical company Roche filed an action in December 2023 alleging that one of Tandem’s insulin pumps infringed upon its patent. Roche was seeking monetary damages and for Tandem to stop selling the t:slim X2 pump. San Diego-based Tandem will make an initial payment of $8 million under the agreement and pay out the remaining balance in equal installments over the next four years.
FDA removes hold on vTv’s cadisegliatin clinical program for diabetes, as reported by ClinicalTrialSarena.com, 18 May 2025.
The US Food and Drug Administration (FDA) has removed the clinical hold on vTv Therapeutics’ cadisegliatin clinical programme, including the Phase III CATT1 trial for type 1 diabetes (T1D). This development allows the company to resume the trial, which is now expected to have a reduced duration from 12 to six months. By doing this, vTv aims to receive topline data from the trial rapidly. The liver-selective glucokinase activator was found to be well tolerated in more than 500 subjects for up to six months of treatment.
vTv Therapeutics CEO, president, and chairman Paul Sekhri said: “We are pleased that the FDA has lifted the clinical hold on our cadisegliatin programme and are eager to resume our Phase III trial. “Cadisegliatin has the potential to be the first oral adjunctive therapy to insulin for T1D, and we look forward to further evaluating the effects of cadisegliatin on glycaemic control and incidence of hypoglycaemia over insulin alone after reinitiating the CATT1 Phase III trial.”
Read more: FDA removes hold on vTv’s cadisegliatin clinical programme for diabetes
FDA okays Roche’s Susvimo as diabetic retinopathy treatment by Anna Bratulic for FirstWordPharma.com, 22 May 2025.
US regulators approved Roche’s Susvimo (ranibizumab injection) diabetic retinopathy treatment, marking the third indication for the Swiss drugmaker’s refillable eye implant following a shaky market reentry.
The FDA’s decision was supported by data from the 174-patient Phase III PAVILION trial, which demonstrated superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared to standard care involving monthly monitoring and as-needed anti-VEGF injections. The product will continuously release a customized formulation of VEGF inhibitor ranibizumab.
The product was initially approved by the FDA in 2021 for wet age-related macular degeneration, but was voluntarily recalled a year later after test results showed some implants did not meet Roche’s performance standards. The company went on to update the Susvimo implant and refill needle, implementing manufacturing process improvements to address the issues. It was reintroduced in the US last July. More recently, US regulators greenlit Susvimo for patients with diabetic macular edema.
Read more: FDA okays Roche’s Susvimo as diabetic retinopathy treatment
May is designated as both Mental Health Awareness Month and National Diabetes Month. This period highlights the importance of mental well-being, especially for individuals with diabetes, as managing the condition can be emotionally demanding. Here’s why this is crucial:
- Diabetes can impact mental health: Living with diabetes, particularly type 1, can be emotionally challenging, leading to stress, anxiety, and even depression.
- Mental health affects diabetes management: Poor mental health can make it difficult to adhere to diabetes management plans, including diet, exercise, and medication, which can lead to higher blood sugar levels.
- Increased awareness is needed: Many individuals with diabetes struggle to access mental health resources or don’t realize the importance of addressing mental health alongside physical health.
- Support is available: Organizations like Joslin Diabetes Center, Beyond Type 1, and Breakthrough T1D provide resources and support for individuals with diabetes and their families.
- Addressing mental health improves overall well-being: Prioritizing mental health can improve the quality of life for individuals with diabetes, helping them manage their condition more effectively and live healthier, happier lives.
Diabetes Mental Health: Understanding Distress, Burnout & Depression with Drs. Steve Edelman & Jeremy Pettus for TCOYD.org,
Living with diabetes is more than a physical condition—it’s a daily psychological challenge that affects millions. In this insightful discussion, Dr. Bill Polonsky joins endocrinologists Dr. Steve Edelman and Dr. Jeremy Pettus to explore the often-overlooked mental health aspects of diabetes management.
Dr. Polonsky clarifies that while many healthcare providers misdiagnose diabetes-related emotional struggles as clinical depression, most patients actually experience “diabetes distress”—a distinct condition requiring different interventions. Whether you’re experiencing frustration with blood sugar fluctuations or complete diabetes burnout, this conversation reminds you that you’re not alone and effective support is available. In this video, you will learn about the following:
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- The critical differences between diabetes distress, clinical depression, and diabetes burnout
- Why treating diabetes distress with antidepressants doesn’t work and what approaches actually help
- How to recognize when frustration with diabetes management has evolved into serious distress
- Resources for finding diabetes-knowledgeable mental health professionals in your area
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Frustrated With Diabetes? How to Channel Distress Into Something Positive by Lauren Plunkett for diaTribe.org, 19 May 2025.
Are you feeling angry and fearful about diabetes? There’s a way to channel that negative energy into something productive and motivating. “My blood sugar was great yesterday, but today, I have absolutely had it. I’m all over the place. I’m putting the work in, and still, my blood sugars will not stop moving. I am so pissed!”
If this resonates with you, perhaps you’re recalling that voice of criticism inside your head going off about time in range or a high blood glucose spike. If you beat yourself up over it or lash out at someone, you are not alone; you’re experiencing diabetes distress, or the way in which diabetes can fuel anger and frustration.
Being in control (of both blood glucose and emotions) or losing it is intertwined with fear. A 2018 study that used movie clips to provoke an emotion found that the induction of fear significantly increased participants’ self-reported anger. The part of the brain that responds to fear interacts with an external orientation, meaning that anger doesn’t spring from thin air but is inspired by a subsequent emotion, such as fear. The participants experiencing negative visuals and language are what drove feelings of fear, followed by anger. Anger stands in the way of compassion, forgiveness, and self-efficacy, or a belief in the ability to care for oneself.
Another 2018 study found that fear and worry are the dominant feelings that affect quality of life in young women with type 1 diabetes; however, as self-efficacy increases, so does quality of life. The way a person thinks about reaching goals and their ability to think positively are examples. This would be a time when your inner voice drop-kicks criticism and says, I know it’s tough sometimes, but you’ve got this!
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