Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings posted by FDA.gov/medical-devices, 5 September 2024.
This recall involves removing certain devices from where they are used or sold, and does not apply to the FreeStyle Libre 3 reader or app. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. This recall involves removing certain devices from where they are used or sold, and does not apply to the FreeStyle Libre 3 reader or app. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
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- Product Name: FreeStyle Libre 3 sensor, a component of FreeStyle Libre 3 Continuous Glucose Monitoring System
- Unique Device Identifier (UDI)/Model: UDI-DI 00357599818005/ Model No 72081-01
- Lot Numbers:
- T60001948
- T60001966
- T60001969
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What to Do: Users of FreeStyle Libre 3 sensors should follow the instructions below to check the sensor serial numbers to find out if the sensor is in the affected lot. Distributors of FreeStyle Libre 3 sensors should check their inventory to find out if there are any affected sensors left in their inventory. Immediately stop using and distributing any affected sensors. Throw affected sensors away.
Reason for Recall: A small number of FreeStyle Libre 3 sensors may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes. The use of affected product may cause serious adverse health consequences, including severe low blood sugar (hypoglycemia) which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage, and death. There have been 2 reported injuries. There have been no reports of death.
Modular Medical Receives FDA Clearance of the MODD1 Insulin Pump announced by Modular-Medical.com, 4 September 2024.
Modular Medical, Inc., an insulin delivery system technology company preparing to launch a market expansion product with a more accessible, easier to prescribe, and easier to pay for and live with technology, today announced it has received US FDA clearance to market and sell its MODD1 pump in the United States. With its commercial manufacturing infrastructure substantially established, the Company anticipates the MODD1 should be available for sale in early 2025.
“For too long, the benefits of superior glycemic control achieved by insulin pumps have, due to cost and complexity, been restricted to only the most sophisticated, motivated and well-insured users. The goal of Modular Medical has always been to change this by making diabetes technology accessible and affordable to underserved communities. We seek to make the experience of going ‘on a pump’ simpler, less intimidating and to widen the base beyond the current pump users,” said Jeb Besser, CEO of Modular Medical.
Read more: Modular Medical Gets FDA Clearance of the MODD1 Insulin Pump
Flying Could Upset Insulin Pump Function for Type 1 Diabetics by Dennis Thompson for HealthDay.com, 9 September 2024.
Diabetics who fly with an insulin pump could find themselves with lower-than-normal blood sugar levels, a new study says. Altitude appears to affect the ability of insulin pumps to deliver a steady supply of the hormone, researchers reported at the European Association for the Study of Diabetes annual meeting in Madrid. “Individuals who use insulin pumps should be aware of the potential impact of changes in the cabin air pressure on insulin delivery,” said lead researcher Dr. Ka Siu Fan, with the University of Surrey in the U.K.
Researchers found that pumps over-delivered insulin during the ascent, but not enough to cause hypoglycemia. At the same time, the pumps under-delivered insulin during descent, which could cause blood sugar levels to spike but not enough to cause health problems.
“To prevent any unintended metabolic consequences, we recommend that individuals who use insulin pumps consider temporarily disconnecting their pumps before take-off and removing air bubbles before reconnecting it at cruising altitude,” Fan said.
Read more: Flying Could Upset Insulin Pump Function for Type 1 Diabetics
Roche to launch new CGM in Europe in ‘coming weeks’ by Elise Reuter for MedTechDive.com, 12 September 2024.
Roche plans to launch its first continuous glucose monitor (CGM) in Europe “in the coming weeks,” Sérgio Moreiras, the company’s international business leader for continuous monitoring, said. The company received a CE mark in July for the Accu-Chek Smartguide, authorizing the device for people ages 18 and up with Type 1 or Type 2 diabetes. Roche will roll out the CGM in the Netherlands, Switzerland, and Germany, Moreiras said at the European Association for the Study of Diabetes annual meeting in Madrid.
Accu-Chek Smartguide can be worn for 14 days and features predictive algorithms that Roche hopes will differentiate it from competitors Abbott and Dexcom. However, it also must be calibrated at first using a finger stick, which some of the newest CGMs do not require. Roche developed the CGM with three different prediction tools: A feature to predict the risk of low blood glucose within 30 minutes, a feature to forecast glucose levels over the next two hours, and a feature to predict hypoglycemia risk at night.
Pau Herrero, an algorithm and decision support tech lead at Roche, said the device provides a different picture than the trend arrows other CGMs use, which typically forecast glucose levels over the next 20 minutes. The predictions are based on multiple days of patient data using machine learning models.
Read more: Roche to launch new CGM in Europe in ‘coming weeks’
You’re Taking Ozempic or Mounjaro for Diabetes. Do You Still Need Metformin? by Ginger Vieira for EveryDayHealth.com, 23 August 2024.
GLP-1 medications like semaglutide (Ozempic) and tirzepatide (Mounjaro) continue to make headlines for their impact on obesity and diabetes. If you have type 2 diabetes, you’ve probably already been prescribed metformin, a common first-line treatment for the condition. If you’re taking a GLP-1 drug for the first time, you might wonder whether or not it makes sense to continue taking metformin. Metformin is among the oldest type 2 diabetes drugs, developed over 100 years ago.
“Diabetes is a complex health condition,” explains Vanessa King RDN, CDCES, a spokesperson for the Academy of Nutrition and Dietetics. “If your A1C is more than 1.5 percent above your target, a combination medication therapy is now the most common strategy per the standards of the American Diabetes Association.” That means taking more than one diabetes drug at once. Even if you are meeting your blood sugar goals with metformin, your clinician may recommend adding a GLP-1 drug for its other health benefits. In fact, these two diabetes medications work very differently even while providing similar benefits. Experts say they work better when taken together.
Metformin is a pill that patients take once or several times per day. GLP-1 medications are generally taken once a week via injection, or less commonly with a daily tablet or daily injections. “Metformin and GLP-1s (like Ozempic) are often prescribed together to manage blood sugar levels for people with type 2 diabetes,” explains King, “because they are different types of medicine that work in synergistic and complementary ways.”
Metformin works mostly by telling your liver to produce less sugar, says King.
“Ozempic and Mounjaro, on the other hand, work by imitating gut hormones that increase your body’s insulin production when you’re eating, slow down how quickly food moves through the digestive tract, and increase satiety and fullness when you’re eating,” adds King. “GLP-1s reduce liver glucose production, too.”
While many of the benefits do overlap, each class of drugs offers different benefits.
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- Long considered the “first line of defense” in treating type 2 diabetes, metformin works primarily by suppressing how much glucose (sugar) the liver produces. It can also reduce your appetite, reduce how much sugar is absorbed from the carbohydrates you eat, and slow down the digestion of your meal. All these effects can help with a small amount of weight loss. “There are so many benefits of metformin. Metformin actually increases your body’s natural GLP-1 production,” explains Lori Wenz, NP, a nurse practitioner who’s been caring for people with type 2 diabetes and obesity for over 10 years at Western Colorado Weight Care in Grand Junction.
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- “GLP-1s like Ozempic have cardiovascular and kidney benefits as well,” explains King. “Research shows it can protect patients with heart disease, heart failure, or chronic kidney disease. But it can also reduce your risk of these conditions if you’re high-risk, including people with diabetes.” In research GLP-1 medications have dramatically delayed the progression of kidney disease, and reduced the risk of death from a heart attack or stroke, two serious conditions that are often complications of type 2 diabetes.
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“We have data from past trials that tirzepatide with metformin show greater weight reduction than tirzepatide alone,” explains Wenz on the benefits of Mounjaro. “Some people think you don’t need anything else, or that metformin isn’t as effective, but we know these medications are most effective when you take them together.” Wenz encourages her patients to take both — if they can access and tolerate both. “Patients definitely get an additive benefit when taking metformin and Ozempic in combination,” says King.
Abvance Therapeutics Announces $3.9M Program Related Investment from the Helmsley Charitable Trust to Support Development of Its Novel Insulin and Glucagon Combined Formulation reported by GlobeNewsWire.com, 10 September 2024.
Abvance Therapeutics, a development-stage biopharmaceutical company founded on breakthrough discoveries from the Vanderbilt University Cherrington Lab, today announced that it has secured a $3.9 million Program Related Investment in the form of a loan from The Leona M. and Harry B. Helmsley Charitable Trust. The funding is non-dilutive and will support the pre-clinical development of ABV100, the Company’s initial proprietary insulin-glucagon combination candidate.
Abvance is developing ABV100, a proprietary rapid-acting insulin and glucagon combination that offers the potential to reduce rates of hypoglycemia while simultaneously allowing patients and their healthcare providers to pursue tighter glycemic control. The Company’s vision is that ABV100, as well as other solutions in its pipeline will one day offer a wider therapeutic window than with insulin alone.
“There is an increasing appreciation of the complex relationship that exists between insulin and glucagon, and this offers innovative treatment potential,” stated Alan Cherrington, co-founder of Abvance Therapeutics and Professor of Molecular Physiology and Biophysics at Vanderbilt University. “We demonstrated that, at certain plasma concentrations, the two peptides work in a glucose-dependent manner where insulin dominates glucagon when plasma glucose rises, and the converse occurs when plasma glucose falls. These findings informed the conduct of a human proof of concept study in subjects with type 1 diabetes where the concept held true,” Dr. Cherrington added.
Read more: Abvance Therapeutics Announces $3.9M Program Related Investment from the Helmsley Charitable Trust
Dexcom CGM Worn in Space for the First Time! by Daniel Trecroci for BeyondType1.org, September 2024.
Astronauts are taking their diabetes tech to new heights—literally! For the first time ever, the Dexcom G6 Continuous Glucose Monitoring (CGM) system is being worn in space as part of the Polaris Dawn mission. Launched on September 10, 2024, the mission aims to explore how spaceflight affects human health, including blood sugar levels.
During their five days orbiting Earth, the crew will run about 40 scientific experiments, with several focused on glucose health. Using the Dexcom G6, scientists hope to understand how being in space impacts glucose regulation, which could help future space travelers—including those with diabetes. Jake Leach, COO at Dexcom, shared, “As the pioneer in glucose sensing, Dexcom has been responsible for bringing almost every major ‘first’ to market for the CGM category.
Leach adds that Dexcom is “thrilled” to play a role in building a future where people with diabetes are empowered to accomplish anything they set their minds to—including the possibility of exploring outer space—without being held back by their condition.
Read more: Dexcom CGM Worn in Space for the First Time!
Drug Interaction Overview: GLP-1 Agonists and SGLT-2 Inhibitors by Priya Patel and Madhumita Rao for EndocrinologyAdvisor.com, 6 September 2024.
With the rising prescribing rates for glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, thorough patient medication reviews are crucial.
A dismissal of medication review can lead to an increased risk for drug-drug interactions (DDIs). DDIs manifest in many ways: medications may interact synergistically, increase therapeutic levels beyond safe limits, and increase the toxicity level of other drugs. Without proper review, prescribers may inadvertently overlook cumulative effects, which can precipitate unwanted, potentially dire, side effects.
GLP-1 Agonist drug list: Ozempic® (semaglutide), Wegovy® (semaglutide), Rybelsus® (semaglutide), Victoza® (liraglutide), Saxenda® (liraglutide), Mounjaro® (tirzepatide), Zepbound® (tirzepatide), Trulicity® (dulaglutide), Byetta® (exenatide), Bydureon® (exenatide)
SGLT-2 Inhibitors drug list: Jardiance® (empagliflozin), Farxiga® (dapagliflozin), Invokana® (canagliflozin), Steglatro™ (ertugliflozin), Seglaro® (ertugliflozin)
Read more: Drug Interaction Overview: GLP-1 Agonists and SGLT-2 Inhibitors
CT scans highlight impact of semaglutide on body composition by Hannah Murphy for HealthImaging.com, 10 September 2024.
Blockbuster weight loss drugs like semaglutide don’t just change the ways bodies look on the outside, they modify body composition as well. Standard clinical measures that gauge weight loss do not paint the full picture of how it affects overall health. Body composition metrics derived from CT scans, on the other hand, can provide greater insight into how losing weight affects the body from a cardiometabolic perspective. Researchers recently detailed exactly how semaglutide affects body composition in new American Journal of Roentgenology research.
“As patients on GLP-1 receptor agonists undergo weight loss (or even weight gain), it is important to understand underlying changes in body composition, including visceral and subcutaneous fat volume, abdominal muscle bulk and quality, bone mineral density, and organ properties (e.g., liver volume and attenuation),” corresponding author Perry J. Pickhardt, MD, from the Departments of Radiology and Medical Physics at the University of Wisconsin School of Medicine & Public Health, and colleagues explained. “Such body composition measures, which cannot be derived from standard clinical assessments (e.g., weight, waist circumference, and BMI), serve as biomarkers for cardiometabolic disease, frailty, and mortality risk.”
visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) area, skeletal muscle area and attenuation, intermuscular adipose tissue (IMAT) area, liver volume and attenuation, and trabecular bone mineral density (BMD).
In the group that lost weight, pre-semaglutide versus post-semaglutide scans showed decreases in VAT (visceral adipose tissue) area, SAT (subcutaneous adipose tissue) area, IMAT (intermuscular) area and liver volume, BMD (trabecular bone mineral density) and an increase in liver attenuation. In contrast, the post-semaglutide scans of the weight gain group showed increased VAT area, SAT area and IMAT area, and decreases in muscle attenuation. In the weight loss group, all shifts in body composition were positive and benefited cardiometabolic health. These metrics offer a fuller picture of the impact of the GLP-1 agonist class of drugs, the group noted.
Read more: CT scans highlight impact of semaglutide on body composition
The 4 largest PBMs control 70% of the market nationally by Paige Minemyer for FierceHealthCare.com, 9 September 2024.
The four largest pharmacy benefit managers in the U.S. control 70% of the national market, and most regional PBM markets are highly concentrated, according to new data from the American Medical Association (AMA).
The study dived into 2022 data on commercial and Medicare Part D plans and found that CVS Health’s Caremark is the largest PBM, owning 21.3% market share. It’s followed closely by UnitedHealth Group’s Optum Rx, which has a 20.8% market share. Express Scripts, a Cigna subsidiary and the final of the industry’s big three companies, has a 17.1% market share. Prime Therapeutics, which is jointly owned by multiple Blues plans, controls 10.3% of the market.
AMA President Bruce Scott, M.D., said in a press release that the findings “warrant attention as Congress and the administration continue their work to protect patients and ensure prescription drugs remain affordable and accessible.”
“The call for increased regulatory oversight of PBM business practices is overwhelmingly welcomed by physicians as a check against possible anticompetitive harm resulting from low competition and high vertical integration in the PBM industry,” Scott said. “The AMA urges careful monitoring, and intervention when needed, of both horizontal and vertical integration to ensure competition in PBM and health insurance markets.” Eighty-two percent of region-level PBM markets would be considered highly concentrated based on federal guidelines. This finding suggests a lack of competition among PBMs, as it indicates relatively few companies provided services to insurers, according to the data.
Read more: The 4 largest PBMs control 70% of the market nationally
Going bananas for leaves as new source of protein powder by Yulia Karra for Israel21c.org, 11 September 2024.
“I’ve always loved proteins,” says Michal Mayer with a sincere smile on her face. “You don’t dedicate your life to this if you don’t love proteins,” the biochemist and head protein researcher at Day 8 tells ISRAEL21c. Day 8 was established in July 2023 by scientists-turned-entrepreneurs Daniel Rejzner, CEO, and Dana Marom, CTO. This Israeli startup specializes in extracting RuBisCO plant protein, coveted by the food industry, from discarded leaves.
RuBisCO (short for ribulose 5-bisphosphate carboxylase/oxygenase) is stored in all green leaves and is considered the most abundant enzyme on Earth. Unlike many other plant proteins, RuBisCO is complete, rich in essential amino acids, vitamins, nutrients, minerals and antioxidants.
“Bananas have an advantage when it comes to the supply chain because they grow all year round,” explains Marom, a biochemist with 20 years of experience in the food industry. “Banana cultivation is one of the most prevalent in the world, while its leaves are very large and strong, so we’re not in the race against time when collecting these leaves,” she says. One of the main advantages of Day 8’s method is that it eliminates the cost associated with growing raw materials only to extract protein from them, such as soybeans. “We knew that working with waste would make us cost-competitive and make it easier to scale up,” notes Rejzner. The method has the potential to recycle up to 2.7 trillion tons of unwanted leaf biomass, helping the food industry reduce its environmental footprint.
In fact, the name “Day 8” is rooted in the belief that the world was created in seven days, and on the eighth day, it became “our responsibility to protect and nurture it.” “On this symbolic eighth day, we find our purpose – to safeguard the planet and its resources by revolutionizing the way we produce and consume food,” says the company’s mission statement.
Marom explains the consistency of the Day 8 protein powder is exactly the same as the consistency of the protein derived from eggs. Rejzner adds that Day 8 products can also serve as a potential replacement for whey protein, a byproduct of cheese production widely used in the fitness industry. “Our product is absorbed better by the body, it’s hypoallergenic, vegan, cheaper and has no aftertaste,” explains Rejzner.
Read more: Going bananas for leaves as new source of protein powder
Regarding pumps in airplanes I personally know of two people who received a large amount of insulin during a flight requiring huge amounts of carbs to cover. Both fly a lot and only experienced this once. Once hypothesis is different types of planes pressurize differently. Another is that a full pump makes this more likely. They both reported their experience.
Sure, I want some ground-up banana leaves. Heck, I may get offered a new product. Go bananas for protein.? Do you know my first product offering? I would not if I were you.
PBM’s need monopoly regulation
I am using jarvance (kidneys) and i love it.