In this week’s issue of The Savvy Diabetic:
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- Sequel twiist Launches July 27
- Vertex Zimislecal Cures Severe Diabetes
- Dexcom Announces AI Photo Logging & “SMART FOOD LOG” for G7 CGM
- Dexcom Recalls 2m CGM Receivers
- Beta Bionics’ iLet Partners with Abbott’s Future CGM-Ketone Sensor
- Gold-Standard Trial for D Kidney Disease
- Is Your HbA1C Accurate?
- TIXiMED Phase 1 Study Oral Disease-Modifying T1D Therapy
- Keeping Your Insulin Cool
- GLOW Gummies Fast-Acting Dextrose
- Iowa Law Blocks PBMs
BREAKING NEWS: Sequel to launch twiist automated insulin delivery system next month by Sean Whooley for DrugDeliveryBusiness.com, 21 June 2025.
Sequel Med Tech announced at the American Diabetes Association’s 85th Scientific Sessions in Chicago that it plans to launch its twiist system in July. Dr. Joanna Mitri, the company’s chief medical officer, announced that the company plans to launch its automated insulin delivery system on July 7. The company had said as recently as March that it previously expected a second-quarter launch.
Read more: Breaking: Sequel to launch twiist automated insulin delivery system next month
People With Severe Diabetes Are Cured in Small Trial of New Drug by Gina Kolata for NYTimes.com, 20 June 2025.
A single infusion of a stem cell-based treatment may have cured 10 out of 12 people with the most severe form of type 1 diabetes. One year later, these 10 patients no longer need insulin. The other two patients need much lower doses. The experimental treatment, called zimislecel and made by Vertex Pharmaceuticals of Boston, involves stem cells that scientists prodded to turn into pancreatic islet cells, which regulate blood glucose levels. The new islet cells were infused and reached the pancreas, where they took up residence. The study was presented at the 2025 annual meeting of the American Diabetes Association and subsequently published online by The New England Journal of Medicine.
“It’s trailblazing work,” said Dr. Mark Anderson, professor and director of the diabetes center at the University of California in San Francisco. “Being free of insulin is life-changing,” added Dr. Anderson, who was not involved in the study. Vertex, like other drug companies, declined to announce the treatment’s cost before the Food and Drug Administration approves it. A Vertex spokeswoman said the company had data only on the population it studied so it could not yet say whether the drug would help others with type 1 diabetes.
Read more:
Dexcom continues advances in AI for CGM by Sean Whooley for DrugDeliveryBusiness.com, 22 June 2025.
From Dr. David Ahn, Chief of Diabetes Services at Hoag Hospital Dick & Mary Allen Diabetes Center, Newport Beach, CA.
At the American Diabetes Association’s 85th Scientific Sessions in Chicago, Dexcom President and COO Jake Leach said a study performed using CGM and food logging showed that people were more engaged with food logging when wearing a CGM versus when they weren’t. Now, the company has a photo meal logging feature brought to the G7 platform. This technology utilizes AI to explain or detect the food. “I took a picture of eggs Benedict and it actually detected that there was crab in it,” Leach said. “It’s pretty impressive. We’re really excited about it and we’ll keep building on that.”
The technology is proprietary to Dexcom’s app, enabled through Google’s Vertex AI. Leach said the food logging comes through the same technology used in the base engines for the Stelo CGM’s insight report. This marks the introduction of the technology to the G7 platform, which currently captures the meal and its description. Down the line, Leach said it could reach the point where it presents macros, such as carbohydrates. After Dexcom continues to build the data library, the AI could start recommending food, suggest portion sizes and further help with insulin dosing or other medications, Leach explained.
Read more: Dexcom continues advances in AI for CG
Dexcom recalls more than 2 million CGM receivers for lack of audible alarm by Elise Reuter for MedTechDive.com, 18 June 2025.
Dexcom started the recall on May 12. For the G7, more than 1.9 million receivers were affected globally, while for the G6, more than 182,000 devices were affected. Tens of thousands of receivers were recalled for Dexcom’s One and One+ CGMs.
The manufacturing problem involves defective foam or an assembly error that may cause the receiver’s speaker to lose contact with the printed circuit board, according to entries posted in the FDA’s recall database. The affected devices will still provide hypoglycemia or hyperglycemia alerts through other cues, such as vibration and visual prompts, according to the database entry.
The recall does not affect people who use Dexcom’s mobile apps to display glucose values and for alerts and alarms, who make up the majority of the company’s users, Dexcom spokesperson James McIntosh wrote in an email. For the affected receivers that have been distributed, the reported incidence rate is .015%, according to the email.
Read more: Dexcom recalls more than 2 million CGM receivers for lack of audible alarm
Beta Bionics Announces Agreement with Abbott to Integrate the iLet Bionic Pancreas with Abbott’s Future Dual Glucose-Ketone Sensor by BioSpace.com, 19 June 2025.
Beta Bionics, Inc., a pioneering leader in the development of advanced diabetes management solutions, announced its intention to integrate its iLet Bionic Pancreas automated insulin delivery (AID) system with Abbott’s future dual glucose-ketone sensor in the U.S.
“This integration holds great promise for further enhancing real-time decision-making support for people living with diabetes,” said Sean Saint, President and CEO of Beta Bionics. “As the benchmark in automated insulin delivery systems, the iLet will naturally integrate with Abbott’s future dual glucose-ketone sensor as soon as it becomes commercially available.”
GOLD-STANDARD trial will test novel combination therapy for diabetic kidney disease by Scott Buzby for Healio.com, 18 June 2025.
Ayodele Odutayo, MD, DPhil, assistant professor in the department of medicine, clinical scientist, and nephrologist at Sunnybrook Health Sciences Centre in Toronto, led a presentation on combination treatment for optimal kidney and CV outcomes and shared details of a planned trial to evaluate just that.
“We have multiple medications to treat diabetic kidney disease. Historically, the only option was [renin-angiotensin system] inhibitors. But now we have SGLT2 inhibitors, nonsteroidal mineralocorticoid receptor antagonists (MRA; finerenone [Kerendia, Bayer]) and GLP-1s,” Odutayo said during the presentation. “These medications have substantial benefits in terms of reducing the risk of [chronic kidney disease] progression and CV events. But despite that, these medications are infrequently used separately and also not in combination.”
“We’ve only had one medicine for a long time, and now we want to add three. These medicines have not been directly studied together … so we thought the best person to tell us what they want is our patients. We engaged with patients over the last few weeks, asking about what they would want given the change in therapeutic landscape,” Odutayo said. “They want these medicines started through shared decision-making and iterative assessment of risk. What that means is they don’t want to come into my office and be told they need four medicines at the outset. They want me to start, see how they do, and explain to them why we either need to intensify therapy or add another agent.
Read more: GOLD-STANDARD trial will test novel combination therapy for diabetic kidney disease
Did you know your A1C might be inaccurate? by Audree Hall for TimeInRange.org, 12 May 2025.
Hemoglobin A1C (HbA1c or “A1C”) is the metric most often used in healthcare offices, but it can be inaccurate for certain groups and medical conditions. An A1C test measures how much hemoglobin (an essential component of red blood cells) has sugar attached to it. Once a red blood cell becomes coated with sugar, the sugar stays there for 2-3 months (this is why you get your A1C tested every 3 months). A1C results can be influenced by the rate of red blood cell turnover, which means they may not accurately reflect the amount of sugar attached to the blood cells.
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- People of color: Studies show that A1C values are less accurate for people of African, Mediterranean, or Southeast Asian descent. Specifically, A1C has been shown to overestimate glucose levels in African American individuals frequently. Genetic variants can also cause hemoglobinopathies, a group of blood disorders and diseases that affect red blood cells, which can affect A1C results, as the A1C test does not account for these differences in hemoglobin.
- Older Individuals: As people age, they become more susceptible to changes in their red blood cell turnover rate. Older populations have a higher risk of conditions that affect these rate changes, including iron deficiency (anemia), dialysis, sickle cell anemia, recent blood transfusions, and others. This can affect A1C results, making them inaccurate, either higher or lower than the actual average blood glucose level. A1C also does not show low glucose patterns, which is extremely important to monitor in older individuals, as low glucose can lead to injuries or cognitive issues. Solely using A1C in diabetes management could increase hypoglycemia risk in older people with diabetes, meaning more hospital visits and potentially dangerous situations.
- Pregnancy: A study has found that, similarly to aging populations, pregnancy changes the life cycle of the red blood cell, which can affect A1C. Another study found that using A1C could provide false reassurance if it’s used to measure glycemia in mid- to late-gestation without accounting for the proper factors.
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Read more: Did you know your A1C might be inaccurate?
TIXiMED Announces Successful Completion of a Phase 1 Study of its Novel Oral Disease-Modifying Type 1 Diabetes Therapy on BusinessWire.com, 29 May 2025.
TIXiMED, Inc., a clinical-stage pharmaceutical company developing a novel disease-modifying oral therapy for type 1 diabetes (T1D), today announced the successful completion of the Phase 1 Single Ascending Dose (SAD) study for TIX100. This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post-hoc analysis revealed a decreased postprandial blood glucose excursion and improved glucose homeostasis after a standardized liquid meal in the two highest-dose cohorts, providing the first evidence of a biological effect of TIX100 in humans.
“We are thrilled with the successful completion of the Phase 1 SAD study, which demonstrated the safety and tolerability of TIX100 in humans,” said Dr. Anath Shalev, Founder and Chief Scientific Officer at TIXiMED. “We are also excited that, despite the small sample size and healthy study population, a promising metabolic TIX100 signal became evident at the human dose predicted in preclinical models,” Dr. Shalev added. “These findings also suggest that stronger effects might be observed in people with diabetes and bring TIXiMED closer to delivering a novel oral therapy that addresses the underlying causes of T1D, offering hope for improved outcomes for patients across all stages of the disease.”
TIXiMED is a pharmaceutical company dedicated to developing and commercializing a first-of-its-kind oral therapy for type 1 diabetes based on inhibition of the protein TXNIP. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small-molecule TXNIP inhibitor and its derivatives, which have been shown to protect against models of type 1 and type 2 diabetes, as well as metabolic dysfunction–associated steatotic liver disease.
Read more: TIXiMED Successful Completion of a Phase 1 Study of Novel Oral Disease-Modifying T1D Therapy
How To Help Keep Your Insulin (and Other Diabetes Meds) Cool by Paul Hetzel for diaTribe.org, 16 June 2025.
Insulin is a protein made up of molecules arranged in a specific order. It travels through the bloodstream and acts like a key, binding to insulin receptors — special proteins on the surface of cells that act like locks. When everything is working properly, these receptors open cells to allow glucose to enter and be used for energy. But when insulin is exposed to extreme heat or cold, its molecular structure can change, making it less effective at doing its job.
At Home: Insulin is best stored in the refrigerator until it’s time to use it. The American Diabetes Association (ADA) recommends storing insulin that is not in use in the refrigerator at temperatures between 36°F and 46°F. Fluctuating temperatures can reduce the effectiveness of insulin, resulting in unpredictable effects and a shorter time spent in the target range. Studies have found that the temperature in refrigerators can vary widely.
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- While the butter compartment or refrigerator door shelves may seem like good spots for insulin, frequent opening and closing can cause those areas to run warmer than the main compartment. Similarly, the bottom shelves and drawers often run colder, sometimes so cold that insulin can freeze, rendering it ineffective.
- Some have recommended storing insulin on the middle shelf of the fridge. However, with temperature variations across different refrigerator models and sections, researchers have expressed hesitancy to suggest the ideal spot. If you’re concerned about fluctuations, consider a wireless thermometer ($20-$40 online) that connects to your smartphone and sends alerts if temperatures exceed the range you’ve set.
- Some people find that injecting cold insulin can be painful, so you can let it warm to room temperature before using. The ADA recommends storing insulin at a temperature between 59°F and 86°F for approximately a month.
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How to store other diabetes medications: If you’re using other diabetes or weight loss medicines that need refrigeration, such as a GLP-1 agonist like Ozempic or a dual-agonist like Mounjaro, the storage recommendations are very similar to those for insulin.
How to beat the heat: Instead of leaving medication in places that can get very hot or cold, like the glove box of a car, try an insulated container you can keep with you to maintain a safe temperature. There are plenty of flexible and convenient options available.
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- Portable thermal bags that contain reusable gel packs are readily available online and typically cost under $20. The gel packs or the entire container are set in a freezer for a set number of hours (for example, overnight), then stay cold for a day or more.
- For road trips, a cooler with medication stored in a watertight container will suffice. Just keep a buffer between the ice and your insulin.
- The wireless thermometers previously mentioned can also be helpful for travel and can be placed in the container holding your medication. Look for ones that send a notification to your smartphone if the temperature falls outside the manufacturer’s recommended range.
- Some portable cases, like those from FRIO ($27 to $39), use evaporative cooling to maintain a safe temperature.. You can find ones that are ideally sized for the number of insulin pens, auto-injector pens, or vials you want to carry.
- For those who use injector pens, the VIVI Cap ($169) will protect them from extreme temperatures and track doses via smartphone.
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Read more: How To Help Keep Your Insulin (and Other Diabetes Meds) Cool
New Product: Glow (glucose) Gummies were created for people with insulin-requiring diabetes, by a person living with T1D, and from feedback from people living with T1D.They provide an extremely usable, easy-to-carry, easy-to-take, low-glucose treatment.
DISCLAIMER: I have not tried these so this is not an endorsement … but if you love these, please share your experiences!
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- Made with fast-acting dextrose (like glucose tabs)
- Rapid recovery to help avoid rebound highs
- Delicious and easy to chew (no chalky texture)
- Easy to measure (4g of carbs per gummy, same as the glucose tabs)
- Health-focused formula of clean and natural ingredients (vegan, gluten-free, fat-free, caffeine-free, sodium-free, no red dye)
- Resealable and portable (available in a variety of packaging options to fit your lifestyle)
- Heat-stable (up to 200°F — great for sports and summer)
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Read more: Glow Gummies
Iowa passes law imposing tighter restrictions on PBMs by Susanna Vogel for HealthCareDive.com, 16 June 2025.
Iowa passed a law last week that places limits on pharmacy benefit managers, joining a growing number of states cracking down on the drug middlemen to constrain rising prescription drug costs and protect rural pharmacies.
The legislation includes numerous provisions aimed at curbing pharmacy benefit managers’ (PBMs) “outsized control” over the pharmaceutical supply chain, Gov. Kim Reynolds said in a statement. That includes preventing PBMs from steering patients to particular pharmacies, equalizing reimbursement between pharmacies, and reforming how PBMs are paid.
However, some experts have raised concerns that the law could lead to higher costs for health plans and patients.
Read more: Iowa passes law imposing tighter restrictions on PBMs
