Tidepool Announces FDA Clearance of Tidepool Loop was released on 24 January 2023.
Tidepool, a 501(c)3 nonprofit committed to empowering the next generation of innovations in diabetes management, announced the FDA clearance of Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in persons six years of age and greater.
Tidepool Loop, a patient-led project, is the first application of its kind to receive clearance from the FDA and is also the first to enable insulin delivery from a compatible Apple Watch. The algorithm technology in Tidepool Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend and deliver correction boluses when glucose values are predicted to exceed predefined thresholds.
Read more: Tidepool Announces FDA Clearance of Tidepool Loop
Insulet reports personal-data leak of 29,000 insulin pump customers by Nick Paul Taylor for MedTechDive.com, 24 January 2023.
Insulet said it may have revealed certain personal information about 29,000 Omnipod DASH customers to some of its partners. In an email to customers, the insulin pump manufacturer said an earlier recall communication notifying customers of battery problems with the Omnipod DASH revealed customers’ IP addresses and their use of the device. Insulet said its website performance and marketing partners were the only third parties to see the data and the leak was fixed on the day it was discovered late last year.
The problem stemmed from an email Insulet sent on Dec. 1 to request acknowledgment of an earlier medical device correction notice. Each email included a link to a unique verification page. The URL for the unique verification pages included the customer’s IP address, which someone could use to identify their location, and showed they used Omnipod DASH and a personal diabetes manager. Insulet shared the URLs with its website performance and marketing partners through cookies and other trackers embedded in the code on the acknowledgment page. The company’s notice lacks details of the partners that accessed the URLs.
Omnipod.com, the domain covering the unique verification page URLs, asks users to accept multiple cookies. The list includes cookies from VWO, a provider of an A/B testing tool, and Optanon, a service that places a custom cookie disclosure notice on websites. The notice on Omnipod.com says the site may share information with social media, advertising and analytics partners.
Where possible, Insulet is asking its partners to “delete logs of the IP addresses and unique URLs so that they would not continue to have access to that information.” Insulet disabled all tracking codes on the acknowledgment page on Dec. 6, the day it learned of the privacy incident. The company has reported the incident to the U.S. Department of Health and Human Services.
Read more: Insulet reports personal-data leak of 29,000 insulin pump customers
World-Renowned Immunologist Named Scientific Director of Diabetes Research Institute by Richard Westlund for University of Miami Miller School of Medicine’s Physician-news.umiamihealth.org.
One of the world’s leading diabetes experts, Matthias von Herrath, M.D., has been named the new scientific director of the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine. Dr. von Herrath takes over the lead position at the institute which is among the top in the world, focused on cure-based research and advancing the integration of medicine and technology.
“I look forward to advancing the institute’s mission of accelerating curing type 1 diabetes,” said Dr. von Herrath, who will hold the Stacy Joy Goodman Chair. “Recent studies point to promising new directions in diabetes research at the scientific and clinical levels. It has never been a more exciting time!”
Dr. von Herrath joins the Miller School after serving as professor at the La Jolla Institute for Immunology in San Diego. He is vice president and senior medical officer for Novo Nordisk, Inc., a Danish pharmaceutical company.
Dr. von Herrath brings more than 25 years of dedicated research into diabetes and was twice ranked as the “#1 Juvenile Diabetes Expert” by Expertscape. He was the recipient of the American Diabetes Association’s outstanding scientific achievement award in 2008, the German Diabetes Society’s Langerhans award in 2014, and a lifetime achievement award from The Network for Pancreatic Organ Donors with Diabetes (nPOD).
Read more: World-Renowned Immunologist Named Scientific Director of Diabetes Research Institute
Medtronic wearable partner files for bankruptcy but plans to continue ‘without interruption’ by Nick Paul Taylor for MedTechDive.com, 27 January 2023.
Rockley Photonics has filed for bankruptcy 10 months after partnering with Medtronic on the development of wearable devices. While Rockley works with two of the top five medtech companies, plus six leading smart watch manufacturers including Apple, it has run into financial problems. The company wants to “continue to conduct its business without interruption” throughout the bankruptcy proceedings and emerge from the process with $35 million for ongoing operations.
Rockley landed the deal with Medtronic on the strength of Bioptx, its wrist-bassed technology for sensing biomarkers such as body temperature, blood pressure, body hydration, alcohol, lactate and glucose. The technology is central to the company’s plans to expand beyond consumer electronics and into healthcare. Rockley plans to ship its first Bioptx health monitoring product this year.
“The Company expects customers will initially use the Bioptx platform to monitor the general wellness of individuals under care or in studies,” Rockley wrote in a bankruptcy filing. “After products in the Bioptx line receive approval from the FDA or other regulatory bodies, the Company anticipates that customers will expand product use into preventive and diagnostic care, such as remote patient monitoring and diagnosis.”
Money is an impediment to Rockley’s plans. The company ended September 2022 with $4.9 million in cash and equivalents, down from $36.8 million at the start of the year. Rockley’s short-term investments went from $27 million to zero over the same period.
Read more: Medtronic wearable partner files for bankruptcy but plans to continue ‘without interruption’
All about Exercise: Are you getting ENOUGH?
Massive study uncovers how much exercise is needed to live longer by Sara Berg for AMA-Asson.org, 26 January 2023.
Consistent exercise is good for a person’s health and well-being—that is well known. But how many minutes of moderate or vigorous physical activity are needed to lower the risk of premature mortality? A study published in the journal Circulation defines that number and shares guidance on what level of physical activity is needed to maintain health and improve fitness.
While the 2018 physical activity guidelines recommend that adults engage in at least 150 to 300 minutes per week of moderate exercise, 75 to 150 minutes each week of vigorous movement or an equivalent combination of both intensities, it turns out that if adults do more than the recommended amount, it can help them live longer. Moderate physical activity is defined as walking, weightlifting and lower-intensity exercise. Meanwhile, vigorous exercise is categorized as running, bicycling and swimming.
The study found that those who worked out two to four times beyond the minimum physical activity recommendations had a lower risk of death from cardiovascular disease. Additionally, adults who worked out two to four times more than the vigorous physical activity recommendations—about 150 to 299 minutes per week—were found to have 21% to 23% lower all-cause mortality, according to the study. They were also reported to have 27% to 33% lower cardiovascular mortality and 19% lower non-cardiovascular mortality.
Read more: Massive study uncovers how much exercise is needed to live longer
Most Americans Aren’t Getting Enough Exercise, Study Finds by Tanaz Meghjani for Bloomberg.com, 26 January 2023.
Americans aren’t exercising enough. Less than a third of US adults meet suggested benchmarks for aerobic and muscle-building activities set out by health officials, according to a new study. The US Department of Health and Human Services recommends healthy adults spend at least 150 minutes per week — roughly 20 minutes a day — doing moderate-intensity aerobic exercise and at least two days per week doing muscle-strengthening activities.
People living in rural areas were even less likely to get enough exercise: Only 16% of people outside cities met benchmarks for aerobic and muscle-strengthening activities, compared with 28% in large metropolitan city areas.
Regional differences emerged as well. People living in the South were less physically active than those in other regions, while people in the West were most active.
Read more: Most Americans Aren’t Getting Enough Exercise
The Platinum Rule asks clinicians to look at their values by Riva Greenberg for DiabetesStories.com, 22 January 2023.
You may be familiar with what’s known in diabetes and medical community as #languagematters. It began as a global advocacy movement and now has a lot of research and recommendations behind it. As you might imagine, it reminds health professionals that the language they use with people who have diabetes should not be judging and negative but realistic and supportive. That this affects outcomes.
Similarly, this morning I read in the Scientific American, “Beyond the Gold Rule: Clinicians need to understand patients’ values, not apply their own.” That what also makes a difference in how we tend to people is values. Physicians, largely, of course not all, tend to swim in the sea of their values mostly ignorant of their patients’.
As the author, science journalist Claudia Wallis, points out, “In the arena of medicine, the stakes for making or influencing choices for others can be especially high. Such choices impact people’s quality of life and even their chances of survival. As health care becomes less paternalistic and more individualized, the time seems right for a new ethical guideline. Enter the “platinum rule,” proposed by Harvey Max Chochinov, a professor of psychiatry at Canada’s University of Manitoba: do unto others as they would want done unto themselves.
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I am so excited about Tidepool getting clearance to market its algorithm, I am so hopeful Dialoop will enter the market soon and maybe we can pick hardware, buy software and mate the two for best outcomes. I am excited that we have a serious revolution at hand.