Know Labs unveils non-invasive glucose monitor KnowU for GlobalData.com, February 2024. (Check back soon for a review of many of the more likely non-invasive CGMS in development!)
Know Labs has announced the launch of KnowU, its latest wearable non-invasive continuous glucose monitor (CGM). The device enhances the user experience with features such as a rechargeable battery and a companion mobile app.
The KnowU represents the culmination of an eight-month accelerated development process. An initial prototype was released in June 2023. The device integrates a proprietary sensor, which has demonstrated stability and accuracy in a laboratory setting and is now miniaturized for wearable use. Designed for versatility, the KnowU can be attached to the body using an adhesive or worn on the wrist or forearm with a strap.
The device, set to undergo FDA clinical trials, will focus on collecting extensive data to assess the technology’s performance over continuous wear, across various body locations and within broader glycemic ranges in diverse populations. It operates on the principle of dielectric spectroscopy, utilizing an RF sensor to measure glucose levels.
Read more: Know Labs unveils non-invasive glucose monitor KnowU
ViCentra’s Consumer-Centric Patch Pump by Mary Thompson for MyStrategist.com, 28 February 2024.
ViCentra, founded in 2013 and based in the Netherlands, has a tiny wearable insulin pump called Kaleido that is reusable, comes in 10 vibrant colors, and offers more flexibility than other patch pumps on the market. The Kaleido patch-pump system comes with two durable pumps, a handheld controller, a disposable insulin cartridge that lasts three days, and a choice of two external infusion sets: a short set that can be placed on the body right next to the pump, or a longer infusion set that enables the pump to be carried in a pocket. Although the system is not tubeless, the pump is sleek, small, and lightweight (50 mm× 35 mm× 12.5 mm and about 19 grams) and comes in appealing colors that could strike a chord with pumpers.
Kaleido was CE marked in 2016, with a soft launch OUS in 2018, but ViCentra soon ran into manufacturing scalability challenges. In early 2020, the company voluntarily withdrew from the market while it worked to resolve these issues. After raising a $74 million Series C round in late 2021, ViCentra was able to modernize its production facility, improve the manufacturing design, and transfer its infusion set manufacturing from a US contract manufacturer to its own facilities in the Netherlands. In March 2023, ViCentra commenced a successful test relaunch of Kaleido in the Netherlands and France. This was followed in November by a full commercial launch in Germany, the Netherlands, and France of both the stand-alone Kaleido system as well as a new hybrid closed-loop version using Diabeloop’s DBLG1 self-learning AID algorithm and Dexcom’s G6 CGM. The company expects to launch this year in additional European markets, including the UK.
Kaleido comes with two rechargeable pumps so that one is always charged and ready to go (a charge lasts three days). Moreover, users can pause the pump, take it off for a while, and then put it back on without having to change their infusion set. The current Kaleido pump is considerably smaller than Omnipod but the next-generation Kaleido is planned to be even smaller. The system uses a unique non-syringe pumping mechanism invented and patented by ViCentra. It has a small pumping mechanism in the head of the insulin cartridge that pulls up 0.5µL with every stroke; dosing is accomplished by the number of strokes per minute. Using this technology, the company has been able to design a very accurate and extremely small pump, even at low doses. ViCentra is also developing a smartphone app designed to be simple and intuitive to use, and it has a tubeless patch-pump prototype in early-stage development as well. The latter will still use a durable, rechargeable pump, and users will be able to disconnect from the pump at will.
As for ViCentra’s US plans, the company will wait until it has European Medical Device Regulation (MDR) certification, which it hopes to obtain early this year, before turning its attention to the US market. It plans to make a few modifications to the system, including adding smartphone control, before submitting a 510(k), and is unlikely to obtain US market clearance before 2026.
Read more: ViCentra’s Consumer-Centric Patch Pump
Innovative MicroGlucagon solution aims to transform insulin therapy for type 1 diabetics from the Norwegian University of Science and Technology (NTNU), 22 February 2024.
Researchers in Trondheim are developing a new medicine for diabetics who have to have daily injections of insulin. The key is a hormone that causes the smallest blood vessels to relax on the inside. The Artificial Pancreas Trondheim (APT) research group has now applied for a patent for a new solution they call MicroGlucagon. It can help type 1 diabetics tackle a major challenge, by inhibiting the rise in blood sugar after meals, giving them much better control over their blood sugar levels.
Insulin is needed to lower blood sugar levels. Diabetic patients lack this hormone, because their pancreas has stopped making it. They must therefore take an accurate dose themselves, at the right time – several times a day. This poses a fine balancing act: Too much or too little insulin, can have fatal consequences.
In the new approach developed by researchers at the Norwegian University of Science and Technology (NTNU) and St. Olavs Hospital, microamounts of glucagon have been added to regular rapid-acting insulin mixtures. Glucagon is a hormone that greatly increases blood flow in the exact area of the dermis where insulin is administered. The solution provides the body with extra impetus to quickly absorb the insulin the patient takes with their meals.
“The most important thing is that when insulin is absorbed faster, it also disappears from the body faster.” The researchers believe that their solution may also reduce the risk of low blood sugar for as long as to 3-5 hours after meals. Low blood sugar after meals can be a problem for some patients.
Read more: Innovative MicroGlucagon solution aims to transform insulin therapy for type 1 diabetics
UK invalidates two patents apiece for Abbott and Dexcom in vast CGM battle by Amy Sandys for Juve-patent.com, 18 January 2024.
In the next round of litigation between Abbott and Dexcom over continuous glucose monitoring devices, the UK High Court has found four patents invalid. The two parties are engaged in a fierce battle over the medical devices, which patients with diabetes use. Their dispute has also reached the Unified Patent Court. The dispute spans several countries, among them the UK, Spain, and Germany, as well as parallel proceedings at the UPC and the EPO.
Abbott and Dexcom argue infringement
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- In the Trial A proceedings, Abbott contended that Dexcom’s G6, G7, and D1 systems infringe EP 627 and EP 223, while Dexcom counterclaimed for invalidity – in both cases based on lack of novelty and/or inventive step and insufficiency, and about EP 627 also for lack of patentable subject matter.
- Likewise, Dexcom contended that Abbott’s FSL2 and FSL3 systems infringe EP 159, while Abbott counterclaimed for lack of novelty, lack of inventive step, and insufficiency. Regarding EP 539, Dexcom accepted the patent as invalid as granted and applied to amend the patent unconditionally on the grounds of clarity and extension of scope. Should the court have accepted the amendments, EP 539 would become materially the same as EP 159.
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Read more: UK invalidates two patents apiece for Abbott and Dexcom in vast CGM battle
Insulet sizes up competition as Tandem, Medtronic plan new insulin patch-pumps by Elise Reuter for MedTechDive.com, 29 February 2024.
Insulet could face new competition as other insulin pump companies move into tubeless devices, but CEO Jim Hollingshead said he is not concerned in the short term. The company currently is the fastest growing in the insulin pump market, but it could face pressure in the next couple of years from Tandem Diabetes Care and Medtronic, which have said they are working on their own patch pumps. “We’re never complacent. We have a lot of respect for our competitors and know that because … Omnipod 5 has been so successful, everybody wants to chase it,” CEO Jim Hollingshead said. “We are very confident in our competitive position. We don’t see anything coming in anybody’s pipeline that even matches what we have, and we’re going to continue to drive innovation.”
Tandem is working on a tubeless option for its Mobi insulin pump, a small durable system that it launched earlier in February. Tandem is also developing a rechargeable patch pump that uses prefilled cartridges, called Sigi, which the company acquired when it bought Switzerland-based AMF Medical two years ago.
Meanwhile, Medtronic diabetes president Que Dallara says that the company is “aggressively moving” to get next-generation tethered pumps and patch pumps to market. At the end of the year, the company called off plans to buy patch-pump maker EOFlow, which currently is in a patent battle with Insulet.
Read more: Insulet sizes up competition as Tandem, Medtronic plan new insulin patch-pumps
BEWARE: Facebook copyright scam intensifies, users left stranded by Justinas Vainilavicius for CyberNews.com, 16 November 2023.
The Facebook copyright infringement scam appears to have intensified, with users reporting being locked out of their accounts with little help from the Meta-owned social media platform to restore their access. The scam targets Facebook users by sending them fake copyright infringement notices and stealing their credentials. While it’s been making the rounds for most of 2023, the scam seems to have grown in scale in recent weeks. Numerous users have reported that they’ve fallen victim to it, losing access to their accounts and receiving little help from Facebook in reinstating them.
Victims reported their accounts being renamed to “Meta Copyright Infringement” and sometimes disabled. Some said that they’d experienced credit card fraud, suffered damages over suspended business accounts, or lost pictures posted over the years as a result. Others recounted how their hacked accounts were used to share explicit or violent content. Users also complained that they struggled with the appeal process, expressing frustration over the lack of communication from Facebook.
“The best advice I can give is to know that Facebook will not send you a direct message, ever, especially to a personal account. If you are seriously in violation of a copyright issue, it will appear in your notifications, not Messenger, and most likely not in your email,” Joe Karasin, head of the Karasin PPC digital marketing company said. Users should also never click on the links in messages from people they don’t know. “If someone you do know messages you but they seem off, ask them a question only you and they would know the answer to. If they can’t answer it, block and report the account immediately,” Karasin said.
In any case, users should report that their account was compromised at facebook.com/hacked, said Gary Huestis of Powerhouse Forensics.
It happened to me! It’s totally evil and devastating, to lose all my content and access to the diabetes support community. Seems Facebook DOES NOT CARE!
Read more: Facebook copyright scam intensifies, users left stranded
A remarkable increase in survival by Rachel Clayton for LifeForAChild.org, 26 February 2024.
If you are reading this, you likely have an understanding of the immense challenges faced by young people managing T1D in under-resourced communities. Now, imagine navigating this terrain in Burkina Faso, where the absence of pediatric endocrinologists adds an extra layer of difficulty.
In 2013, Life for a Child forged a groundbreaking partnership with Yalgado Ouedraogo University Hospital and the NGO Santé Diabète. This collaboration aimed to provide diabetes management supplies and reliable support to children and young people living with diabetes. We also started collecting data, to capture the health outcomes and experiences of young people we support.
In 2013 there were only 22 known children and young adults with T1D under 25 years old in Burkina Faso. We knew from experience that there should be many more, and it was highly likely that many young people would be dying from misdiagnosis or lack of access to supplies and education. Today, after ten years working in the country, our suspicions have been confirmed. Between 2013 and 2022, 312 new cases of T1D were diagnosed, five cases of T2D and two suspected cases of maturity-onset diabetes of the young.
Dr. Yempabou Sagna is an endocrinologist at our local partner center in Burkina Faso and one of the authors of the study. He said, “I think the most positive finding is that there is sharply rising T1D incidence, mainly due to increased detection rate with the support of Life for a Child. Many of these patients would likely have died unrecognized from non-diagnosis.
Read more: A remarkable increase in survival
Diabetes Technology and Pets: A Market of the Future? research findings led by Lutz Heinemann, PhD and published by Sage Journals, 11 July 2023.
Diabetes is a widespread disease amongst animals; the focus here is on dogs and cats. There are estimates that 900 million dogs and 600 million cats live on the earth. It is assumed that 1.2% of the dogs in Europe will develop diabetes during their lifetime and 0.4% of the cats. In other words, a rough guess is that 1 million dogs in Europe have diabetes and 0.5 million cats. The global pet diabetes care device market is assumed to be $1.9 billion in 2021 and is projected to reach $3.5 billion by 2031.
To provide more constant information about the glucose profile of the animals, a system for continuous glucose monitoring (CGM) can be used. However, fixation of a CGM system to the skin requires shaving a good portion of the fur and good fixation, otherwise, the dog or cat will remove the sensor.
It appears as if horse diabetes is not a big topic; however, like in human athletes, the glucose information provided by CGM systems can be used for optimizing the performance of racehorses. CGM systems are also in dairy cows.
Read more: Diabetes Technology and Pets: A Market of the Future?
5 Emerging trends in personalized medicine by Lisa Magloff for InterestingEngineering.com, 29 February 2024.
Advances in personalization are already having a big effect on healthcare. From diagnostic and drug delivery to patient care, personalized medicine is set to change the entire healthcare landscape. Here are some of the areas where this is already occurring.
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- Direct Primary Care: Direct primary care (DPC) is not a form of medicine but medical billing. However, countries that do not have a national health care system or widely affordable comprehensive insurance may allow more people to receive care for less.
- Biomarker testing and targeted therapies: Biomarker testing looks for genes, proteins, and other substances that can provide information about illness, especially cancer … because diseases can be different in each person
- Nanorobots: In the future, once a targeted treatment is devised, doctors may be able to use nano-scale robots to deliver the medication directly to the site of the disease.
- Biosensors and wearables: Watches or rings incorporate a variety of sensors to track health data such as heart rate, blood pressure, sleep patterns, and physical activity. This data is then analyzed and used to deliver personalized health plans, such as changes to diet and exercise, or can alert doctors to the need for specific tests.
- AI in diagnostics and care: One of the most promising areas is using AI algorithms in imaging analysis, such as AI-based assistance to check for lung nodules or tumors on MRI and CT scans. AI is also being used to identify potential new therapies from databases of information on existing medicines.
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Read more: 5 Emerging trends in personalized medicine
Abbot and Tandem fighting over CGM technology is funny. The two giants slug it out while the little startups keep going. Not for long I suspect. I suspect everyone in this business will ultimately end up suing everybody.
I just hope they will not put each other out of business.
Hey don’t blow the whistle on my Facebook scams. LOL Besides i have long ago moved on to Tick Tock scams. 🙂