Final Day: Make Your Voice Heard AGAIN to the FDA re CGM!
Here’s another chance to tell them, in a few short sentences, what you want, regarding CGM (continuous glucose monitoring) alarms! The FDA has mandated that CGM LOW BG alarms MAY NOT be turned off or silenced. I guess they don’t trust us to manage our own diabetes.Here’s the link: https://www.regulations.gov/commenton/FDA-2018-N-1910-0047
FYI: This is new, about the FDA mandating alarms/alerts that you can NOT turn off. Impacts everyone with a CGM.
What if you are in a business meeting? Theatre? Classroom? People are choosing not to use CGM because the alerts are NOT under our control. Teens should NOT be embarrassed by a screaming CGM. Employees should NOT be shamed or face reprimand from bosses, etc.
The FDA thinks they should force this issue. We know that we should have the right to control our own devices and our own data.
Per JDRF Advocacy and ADAAdvocacy: The Inflation Reduction Act Becomes Law on 7 August 2022.
Congress just passed legislation to address the national crisis of insulin affordability for those in Medicare. Unfortunately, we need to keep fighting, because the bill does not do enough to ensure ALL Americans have access to affordable insulin.
the U.S. Senate passed the Inflation Reduction Act (IRA), which included some provisions regarding insulin. Due to the difficulty of passing bipartisan legislation in an evenly divided Senate, the Inflation Reduction Act was brought up through a process called budget reconciliation. (This process was used because it cannot be indefinitely delayed or blocked via filibuster). This wide-ranging piece of legislation also contains additional healthcare, tax, and climate measures. Its passage comes after months of negotiations between Congress and the Executive Branch.
On August 12, the House passed the IRA and President Biden is expected to sign it next week.
The IRA will address the cost of insulin in several ways. This includes:
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- Capping the monthly insulin cost at $35 for people enrolled in Medicare
- Limiting overall Medicare prescription drug costs to $2,000 per year
- Removing insulin from the deductible for Medicare Part B and D; allowing high-deductible health plans to exempt insulin from the deductible
- Currently, people typically must pay full price for their insulin before they meet their deductible. This change means people won’t have to pay the full price before they hit their deductible.
- Extending existing tax credits that enable people to obtain health coverage at a low cost via the Affordable Care Act’s insurance marketplace
These provisions will make insulin more affordable for several million Americans. However, the bill originally capped the monthly cost of insulin at $35 for both people on Medicare and commercial insurance. It is galling that 43 Senators voted to remove the commercial provision from the legislation; it could have remained in the bill if no one had objected. The good news is that 7 Republican Senators joined all Democrats to support keeping the provision in the bill and more have said they’ll vote for it outside of the budget bill. This gives hope that this can be revisited in the future.
One more note: the Act included language that allows Medicare to negotiate drug prices; however, it is anticipated that most insulin products will not be eligible for negotiation.
Read more:
As Glucagon Options Expand, Lilly Discontinues Emergency Kit was written by Arvind Sommi for diaTribe.org, 1 August 2022.
The Glucagon Emergency Kit is an iconic piece of diabetes equipment that people with type 1 relied on for many decades. The kits themselves were bright, ugly orange and included two separate vials and a long needle. They were not easy to use, and the people who did use them often felt nauseous afterward. But they kept many people alive and therefore will forever be cherished.
In some cases of hypoglycemia, your brain may have difficulty functioning. What begins as a headache and fatigue can quickly become severe with life-threatening symptoms, such as seizures and loss of consciousness. According to the CDC’s National Diabetes Statistics Report, in 2016 alone, 235,000 people went to the emergency room as a result of severe hypoglycemia.
Since 2019, easier next-generation emergency glucagon therapies have been approved … more on your new options for glucagon soon on TheSavvyDiabetic.com. Also looking for a catchy and great slogan as a reminder to all of us T1Ds, endocrinologists and diabetes healthcare providers, first responders, and family/friends/schools
Got Insulin? Need Glucagon! Please share your creative suggestions for glucagon slogan!!!
A sensor fashioned into jewelry can potentially be used as a non-invasive way to measure glucose and other vital signs, was shared by Elizabeth Montalbano for MDDIOnline.com, 8 August 2022.
Researchers from The Ohio State University have developed a device that can be worn around the neck to monitor a person’s glucose levels from sweat excreted when he or she exercises, they said. It could one day be used as a way to help people with diabetes to keep track of their blood sugar without painful pinpricks. The so-called “smart necklace” includes a typical clasp and pendant, but also features a battery-free, wireless biochemical sensor that researchers used to measure test subjects’ blood sugar through their perspiration.
“Sweat actually contains hundreds of biomarkers that can reveal very important information about our health status,” Jinghua Li, assistant professor of materials science and engineering at Ohio State, stated in the Ohio State News. “The next generation of biosensors will be so highly bio-intuitive and non-invasive that we’ll be able to detect key information contained in a person’s body fluids.”
Read more: A sensor fashioned into jewelry
Francine Kaufman, Senseonics’ CMO, talks growing users, a 365-day CGM, doctor recruitment was published by MedTechDive.com, 12 August 2022.
Senseonics is taking a different approach to the development of continuous glucose monitors, devices that help patients with diabetes track their blood glucose levels and have grown in popularity across the world. While CGMs from industry leader Abbott Laboratories last for 14 days and Dexcom for 10 days, Senseonics recently introduced a 180-day CGM and is developing a device that can last 365 days. Its sensors are also implanted in patients, unlike rival devices that are inserted beneath the skin.
Francine Kaufman, Senseonics’ chief medical officer, said that despite being much smaller than its competitors — Senseonics reported $3.7 million of revenue in the second quarter, while Dexcom reported $696.2 million and Abbott’s FreeStyle Libre CGMs brought in about $1.1 billion — the company can compete in the market because patients are searching for new, longer-lasting devices.
Dr. Kaufman says, “The marketing campaign is focused on how different our product is from other products. We’ve been doing a lot of direct-to-consumer marketing and people really like the concept of not having to insert a sensor every seven or 10 or 14 days. So, we are certainly picking up new CGM users but also users of other CGMs who may come off it because they are not satisfied with other options.”
When asked if Senseonics is developing its CGMs to work as part of an automated insulin delivery system with insulin pumps, she responded: “We’ve already had conversations with insulin pump companies to be able to offer that, [and] we are finishing up some studies that we’ll need to do for the FDA. We are planning that sometime next year we will, hopefully, be getting approval. Most likely later next year.”
We do have sensors that clearly survive on the platform we have now, but it’s not to the number of sensors that we like to see. So, we’re developing a new platform. What this will enable is multiple sensing areas on the same small sensor, a change in chemistry and some changes in the algorithms.
Read more: Francine Kaufman, Senseonics’ CMO, talks growing users, a 365-day CGM, doctor recruitment
Insulet raises forecast as Omnipod 5 sales climb; Tandem expects tougher market in second half was reported by Ricky Zipp for MedTechDive.com, 11 August 2022.
While both insulin pump companies grew revenue by at least 10% in the second quarter, Tandem lowered its 2022 forecast on a tougher market, and Insulet increased its guidance.
Tandem CEO John Sheridan said on the recent earnings call that the company is being affected by three main challenges: continuing pressure from the COVID-19 pandemic such as staffing shortages, increased market competition, and macroeconomic factors like inflation and the threat of a recession. Data suggest recession concerns began affecting new customers’ decisions to purchase an insulin pump in the second quarter, according to Sheridan. These factors led to the company cutting its revenue forecast for 2022.
Insulet CEO Jim Hollingshead said on the recent earnings call that Omnipod 5 represented more than 25% of new U.S. customer starts in the second quarter even though the product was still in a limited release. The company moved Omnipod 5 into a full release on 1 August 2022. The launch contributed to a 31% year-over-year revenue growth in U.S. Omnipod sales last quarter, beating company forecasts. Insulet also reported a record number of new customer starts in U.S. and international markets.
Read more: Insulet raises forecast; Tandem expects tougher market
U.S. Declares Monkeypox a Public Health Emergency was reported by Matthew Garza for diaTribe.org, 8 August 2022. Monkeypox has been declared a national public health emergency. Learn what this virus is, its symptoms, and how you can protect yourself and others if you have diabetes (or not).
Monkeypox is a viral infection. The virus that causes monkeypox is from the same family of viruses that causes smallpox (with the help of vaccines, smallpox was eradicated worldwide in 1980). The virus initially spread in central and western Africa but has spread rapidly around the world. In recent months, New York City and San Francisco have announced monkeypox to be a public health emergency. On Aug. 4, the White House followed and declared monkeypox to be a national public health emergency. This new designation increases the number of resources that can be used as part of the federal response.
While this may feel reminiscent of the start of the COVID-19 pandemic, it is important to note that, unlike COVID-19, this virus is not new. It was first discovered in 1958. We already have an understanding of the virus and ways to prevent its spread, and the fact that there are already vaccines and treatments for the virus suggests that it may be less dangerous than COVID-19.
Though monkeypox typically resolves itself without treatment for most people, there is an antiviral treatment that was developed to treat smallpox, called TPOXX, and was also approved to treat monkeypox in January 2022. However, due to limited supply, accessing this treatment can be challenging. And yes, there is a vaccine called Jynneos which can protect you from the Monkeypox virus. This vaccine is not widely available, but the World Health Organization (WHO) is working with the manufacturer to ramp up production in light of the current outbreak.
Right now, there is limited information about whether or not people with diabetes are at greater risk for severe illness from monkeypox. “While there is no evidence that transmission or disease severity is increased in people with diabetes, anyone with very poor glucose control, who as a result might be immunocompromised, might wish to be especially cautious,” said Professor Phillip Home, Emeritus Professor (Diabetes Medicine), Newcastle University, UK.
At this time, the best thing you can do is to be aware of potential outbreaks, avoid close contact with others who have a confirmed or suspected case of monkeypox, and look out for signs of monkeypox symptoms in yourself or others.
Read more: U.S. Declares Monkeypox a Public Health Emergency
I am betting the new Eli Lilly insulin pump will use Senseonics. Whoever gets it will have me as a devotee at least at first.