Fully-implantable CGM receives FDA authorization for integration with insulin pumps by Jill Rollet for Healio.com/endocrinology, 30 April 2024. The Eversense E3 CGM (Senseonics Holdings and Ascensia Diabetes Care) received authorization to be marketed as an integrated CGM through the FDA’s De Novo pathway. The device is the first fully implantable option in the category. The FDA authorization establishes special controls that serve as a predicate device for 510(k) submissions for future implantable devices ..read more

Introducing Cadisegliatin, a New Drug in the Type 1 Diabetes Pipeline by Ross Wollen for DiabetesDaily.com, 26 April 2024. Cadisegliatin, an investigative therapy currently entering phase 3 trials, could be the next important drug, after insulin, indicated for Type 1 diabetes. “Cadi,” as its backers have nicknamed it, works in concert with insulin by helping to improve the liver’s glucose regulation system. Early results suggest that cadisegliatin can flexibly regulate blood glucose levels in response to need by instructing the liver to absorb glucose when there is too much of it in the blood ..read more

JDRF Statement and Update on Insulin Shortage by JDRF.org/press-releases, April 2024. JDRF is aware that, unfortunately, individuals are having trouble filling their prescriptions for 10mL Humalog, 10mL Insulin Lispro, and 10mL Novolog vials. It is unacceptable that some members of our community have had to face an additional hurdle to get this life-saving medication in their usual formulation. We have been in contact with Eli Lilly, the manufacturer of Humalog and Insulin Lispro, and Novo Nordisk, the manufacturer of Novolog, to learn the status of this shortage and what the companies are do ..read more

Lilly’s Carelessness in Discontinuing 3 mL vials of Humalog Causes Shortages in 10 mL vials of Humalog + Unbranded Lispro by Scott Strumello for blog.sstrumello.com, 9 April 2024. In mid-March 2024, the JDRF shared news about how Eli Lilly & Company, Inc. was reporting that 10 mL vials of Humalog and the company’s identical, unbranded (meaning Lilly sells it using the generic drug name rather than brand-name Humalog) version of Humalog known as Lilly Insulin Lispro Injection could be facing temporary lack of availability in selected locations around the country ..read more

The next-gen implantable bioartificial pancreas by Bernard Banga for Medical-Technology.nridigital.com, 22 September 2023. A team from MIT, in collaboration with researchers from Boston Children’s Hospital, has developed a novel implantable device. The O2-Macrodevice not only carries hundreds of thousands of islet cells but is also able to generate its own oxygen supply by splitting water vapor present in the body.  The results of this study, published in Proceedings of the National Academy of Sciences (PNAS), showed that mice implanted with the oxygen-generating device maintai ..read more

Surgeons Transplant Pig Kidney Into a Patient, a Medical Milestone by Roni Caryn Rabin for NYTImes.com, 21 March 2024. Surgeons in Boston have transplanted a kidney from a genetically engineered pig into an ailing 62-year-old man, the first procedure of its kind. If successful, the breakthrough offers hope to hundreds of thousands of Americans whose kidneys have failed. Kidneys remove waste products and excess fluid from the blood ..read more

Eli Lilly warns of temporary short supply of two insulin products by Meg Tirrell for CNN.com/health, 22 March 2024. Drugmaker Eli Lilly warned that two of its formulations of insulin would be temporarily out of stock through the beginning of April, citing a “brief delay in manufacturing.”  The 10-milliliter vials of Humalog and insulin lispro injection will be in short supply at wholesalers and some pharmacies, Lilly said in a statement posted online Wednesday, 3/20/24 ..read more

FDA Clears Twiist Automated Insulin Delivery System by April Hopcraft for diaTribe.org, 18 March 2024. In the latest victory for type 1 diabetes management, the FDA cleared the Twiist AID system, the first automated insulin pump to precisely measure each dose of insulin delivered.  Specifically, the Twiist AID system measures both the volume (amount) and flow (speed) of each micro-dose of insulin. This allows for more personalization of insulin dosing, which could allow for more precise glycemic control and better health outcomes.   What does the Twiist AID system consist ..read more

UPDATES from ATTD (Advanced Technologies & Treatments for Diabetes) 2024, held in Florence, Italy, 6-9 March 2024. The world’s largest congress dedicated to diabetes technology, which concluded last week with over 5000 attendees both in-person in Florence and virtually.  I’m sharing the FIVE standout revelations by Dr. Inge von Boxelaer of Diabetotech.com.  The rollout of Dexcom G7 direct-to-Apple Watch: The feature will be available in March 2024 in UK and Ireland, with wider availability in the first half of this year ..read more

Sensulin’s Biotech Dream Team Is Bringing the Lowest-Cost Smart Insulin to Market by StartUp Health for HealthTransformer.co, 7 March 2024. Sensulin’s idea to create a “smart insulin” (glucose-responsive insulin or “GRI”) is not new. Three of the company’s co-founders were toying around with the idea in the 1990s and 2000s, and the concept has existed in academia for some time. What sets Sensulin apart is their dream team of diabetes researchers and the use of an already-approved insulin as the basis for its formulation, which will help bring glucose-responsive insulin to market ..read more