Abbott gets clearance for Libre 3 reader, opening path to Medicare coverage by Elise Reuter for MedTechDive.com, 17 April 2023.
Since Medicare covers CGMs as durable medical equipment, the devices must include a component, such as a reader, that is expected to last at least three years. Now that Abbott’s Libre 3 reader is cleared, the company said it is working to get the CGM added to Medicare’s list of covered systems “as soon as possible.”
To explain the importance of Medicare coverage, one doctor was putting all of her new CGM patients on Dexcom’s G7 because Abbott’s device is not covered by Medicare. “She mentioned that wouldn’t be the case if reimbursement comes more quickly, especially because she likes the Libre platform.”
It’s also critical as Medicare coverage of CGMs expands this year to include people using all types of insulin, and people with low blood sugar events. The reimbursement expansion went into effect on Monday.
Read more: Abbott gets clearance for Libre 3 reader, opening path to Medicare coverage
FDA Approves Medtronic MiniMed 780G System – World’s First Insulin Pump with Meal Detection Technology announced by Medtronic plc on PRNewsWire.com, 21 April 2023.
Medtronic plc announced U.S. Food and Drug Administration (FDA) approval of its MiniMed™ 780G system with the Guardian™ 4 sensor requiring no fingersticks while in SmartGuard™ technology. This milestone marks the approval of the only system with meal detection technology* that provides automatic adjustments and corrections to sugar levels every 5 minutes for both basal (background) and bolus (mealtime) insulin needs. The system provides insulin to help account for when users occasionally forget to bolus or underestimate the number of carbs in their meals.
“Mealtimes prove to be one of the biggest challenges for people living with type 1 diabetes and now for the first time, the MiniMed 780G system addresses this unmet need with automatic, real-time insulin corrections,” said Que Dallara, EVP and President of Medtronic Diabetes. “A lot can happen to blood sugars in the span of an hour or even just a few minutes, so we’ve designed our system for real life – the algorithm adapts to the user and helps compensate for everyday challenges that are quite common around mealtimes. We built in features informed by extensive customer feedback and we’re excited to deliver a system with ease of use at the forefront.”
The MiniMed 780G system features the lowest glucose target setting (as low as 100 mg/dL) in any automated insulin pump on the market and one that more closely mirrors the average glucose of someone not living with diabetes. With this setting, the pump will “treat to target” and will automatically deliver basal insulin adjustments and autocorrections to a set target. It’s also the only pump with an infusion set that can be worn for up to 7 days, doubling wear time with advanced materials that help reduce insulin preservative loss, maintain insulin flow and stability, resulting in a reduced risk of infusion set occlusion. Combined with the new Guardian™ 4 sensor requiring no fingersticks with SmartGuard™ technology, the MiniMed 780G system delivers a user-friendly design with 94% of users saying they’re satisfied with the impact the system has on their quality of life. Importantly, users also reported remaining in SmartGuard™ technology 95% of the time.
Read more: FDA Approves Medtronic MiniMed™ 780G System
Diamyd Medical partners with JDRF to advance the DIAGNODE-3 Phase 3 trial in Type 1 Diabetes posted by JDRF.org, 4 April 2023.
Diamyd Medical and JDRF have entered into a four-year research and development collaboration including a non-dilutive $5 million award to Diamyd Medical to support its ongoing Phase 3 trial with the precision medicine antigen-specific immunotherapy Diamyd®. The grant will be funded under JDRF’s Industry Discovery & Development Partnerships program which focuses on the commercialization of therapeutics and devices for the treatment, cure, and prevention of type 1 diabetes and its complications.
Diamyd Medical develops precision medicine therapies for Type 1 Diabetes. Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset Type 1 Diabetes in eight European countries and is being prepared to start recruiting patients in the US this summer.
Read more: Diamyd Medical partners with JDRF to advance the DIAGNODE-3 Phase 3 trial in Type 1 Diabetes
JDRF Collaboration Leads to Next-Generation Cell Therapy Research was posted by JDRF.org, 14 April 2023.
Cell transplantation outcomes to restore glucose control have improved over the years, but currently still require immunosuppressive drugs—medications that keep the immune system from attacking these cells and rejecting the implant. Taking these medications can have detrimental side effects on a person’s organs. The need for chronic use of immunosuppressive drugs has limited transplantation to people with diabetes who have severe, life-threatening unawareness of their low blood sugar, or hypoglycemia.
3D bioprinting employs methods used in traditional 3D printing, except it’s used to combine cells and other biomaterials to fabricate tissues and organs. Aspect Biosystems, an industry leader in 3D bioprinting allows for the combination of multiple different biomaterials in one cell-containing implant. Founded in 2013 and located in Vancouver, Aspect’s technology was a perfect match to support development of an implantable insulin-producing cell therapy for T1D without the need for immune suppression.
Aspect Biosystems and Novo Nordisk announced a partnership to expand the development a new class of treatments for diabetes and obesity, using Aspect’s bioprinting technology and Novo Nordisk’s expertise in stem cell and cell therapy development. “With this partnership, we have a leader in the diabetes space, Novo Nordisk, investing in the technology developed by Aspect Biosystems,” said Sanjoy Dutta, Ph.D., JDRF Chief Scientific Officer.
Blackstone Is Using AI to Control Diabetes and Slash Spending on Drugs by John Tozzi for Bloomberg.com, 17 April 2023.
Blackstone Inc. is trying to curb rising employee health costs with an AI-powered individualized approach to diabetes to reduce people’s reliance on costly new drugs. The private equity giant is testing a program from startup Twin Health with workers across 14 of its portfolio companies. The app is designed to help diabetics rely less on expensive drugs to lose weight and control their blood sugar. Patients with uncontrolled diabetes often move from older, lower-priced drugs onto newer pricey treatments made by Novo Nordisk and Eli Lilly that can cost around $10,000 a year.
To help do this, Twin Health uses artificial intelligence and machine learning to analyze data from glucose monitors, activity trackers and surveys. The result is instant, personalized advice for diet, exercise and other activities that takes into account how users are feeling, what they’ve eaten or where they are. If users are able to get their blood sugar under control with these behavior changes, they can feasibly avoid higher-priced drugs.
Read more: Blackstone Is Using AI to Control Diabetes and Slash Spending on Drugs
And now for just a bit of fun: What causes déjà vu? The quirky neuroscience behind the memory illusion by Thomas Ling for ScienceFocus.com, 23 March 2021.
Sorry if you think we’ve already asked, but do you know exactly what déjà vu is? If you’re like most sensible people, you’ll likely say it’s the bizarre feeling that you’ve experienced something that’s happened before. [This is curious to me … have you ever had deja vu about taking a dose of insulin?]
However, many neuroscientists would say this answer lacks a little je ne sais quoi. According to experts like Dr. Akira O’Connor, senior psychology lecturer at the University of St Andrews, déjà vu – the French for ‘already seen’ – is not only a feeling of familiarity, but also the metacognitive recognition that these feelings are misplaced. “Déjà vu is basically a conflict between the sensation of familiarity and the awareness that the familiarity is incorrect. And it’s the awareness that you’re being tricked that makes déjà vu so unique compared to other memory events,” he explains. “Most healthy people don’t tend to believe the sensation of familiarity and change their behavior – they logically know something isn’t right.”
Neuroscientists have determined that this memory illusion isn’t a sign of an unhealthy brain – it’s by no means a memory error. In fact, almost the opposite. As O’Connor argues, déjà vu occurs when the frontal regions of the brain attempt to correct an inaccurate memory. “For the vast majority of people, experiencing déjà vu is probably a good thing. It’s a sign that the fact-checking brain regions are working well, preventing you from misremembering events.
Unfortunately, there is no single agreed model that explains exactly what happens in the brain during déjà vu. However, most of the main competing theories share the same idea: déjà vu occurs when areas of the brain (such as the temporal lobe) feed the mind’s frontal regions signals that a past experience is repeating itself.
“After this, the frontal decision-making areas of the brain effectively check to see whether or not this signal is consistent with what is possible. It will ask ‘Have I been here before?’ “If you have actually been in that place before, you may try harder to retrieve more memories. If not, a déjà vu realization can occur.”
Read more: What causes déjà vu?
I have never experienced deja vu about taking an insulin dose. I’m wondering if others have, though. Deja vu happens to me rarely, but it is an eerie situation when it does. I only experience deja vu around inconsequential events for some unknown reason, so you would think that taking inulin since the 1990s would be routine enough to lead to deja vu at some point. 🙂
Bravo to MedT for getting the 780G approved. It has been a long run to get it approved. This has been such a long road and while MedT could have manged the situation better over the years, I do not blame MedT entirely. Alon with this approval, I hope MedT i working on what comes next.
They cannot take another break and say whew we are equal. Equal for MedT has to be ahead.