In this week’s issue of The Savvy Diabetic:
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Geofencing/Dexcom G7 Update! with Jake Leach
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Senseonics Gets FDA Clearance for 1-year CGM
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Abbott Ramps Up Libre 3 Production
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AI Model to Predict Diabetic Retinopathy
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GC Therapeutics “Supercell” Medicines
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SymbioCellTech’s Stem Cell-Enabled Therapy
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How to Appeal Insurance Denials
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Type 1 Diabetes & Brain Development
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FTC & PMBs Sue Each Other
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Using ChatGPT to Diagnose
Geofencing/Dexcom G7 Update! with Jake Leach and Stacey Simms on Diabetes-Connections.com, 3 September 2024.
Here’s a podcast of Jake Leach, Dexcom’s COO, explaining the Dexcom “fix” to the serious geofencing issue, finally! I’m so glad that after 18 months of being aware of this problem, they are about to institute a solution so that Dexcom G7 users never lose access to their G7 data due to geofencing while traveling away from their home country.
He also talks about Stelo, the new Dexcom CGM, a small biosensor worn on the back of the upper arm that leverages Dexcom’s most accurate glucose-sensing technology. It is specifically designed to provide the 125 million Americans with Type 2 diabetes not using insulin and those with prediabetes with personalized glucose insights sent directly to a smartphone, revealing how food, exercise and sleep can affect glucose – all without painful fingersticks..
Watch the Video: Travel Alert: What You Need to Know About Geofencing and Dexcom G7
Watch the complete interview: Jake
Senseonics receives FDA clearance for one-year CGM by Elise Reuter for MedTechDive.com, 17 September 2024.
Senseonics CEO Tim Goodnow said that the clearance and launch of the Eversense 365 yearlong sensor would be “one of the most significant catalysts in the company’s history.” In addition to the longer wear time, the new sensor requires less frequent calibration using fingersticks; calibration is only required once per week after day 14. The current 180-day sensor must be calibrated twice daily for the first 21 days, and daily after that. Most other CGMs on the market are worn for 10 to 14 days and need to be replaced if the sensor comes off.
Ascensia, which became the exclusive distributor of Senseonics’ Eversense CGM systems in 2020, expects to launch Eversense 365 in the fourth quarter.
Read more: Senseonics receives FDA clearance for one-year CGM
Abbott ramps up Libre 3 production amid shortages by Elise Reuter for MedTechDive.com, 20 September 2024.
Some people who use a Freestyle Libre 3 glucose sensor are facing delays getting their prescriptions filled. Abbott spokesperson Lindsy Delco said the delays are driven by strong demand for the Libre 3 sensors. The company is ramping up production, adding capacity to an existing manufacturing facility this month, and opening a new manufacturing facility later this year. If people cannot get Libre 3 sensors through their pharmacy or mail order company, Delco recommended checking back in a few days to see if they have new supply.
If there are prolonged delays, another option is to talk to a healthcare provider about switching to a prescription for Freestyle Libre 3 Plus, Delco said. The Food and Drug Administration cleared the newer version of the sensor last year. It has a 15-day wear time, instead of 14 days for the Libre 3. The Libre 3 Plus has supply at both pharmacies and mail-order companies.
Read more: Abbott ramps up Libre 3 production amid shortages
NHS develops AI model to predict diabetic retinopathy by Jenna Philpott for MedicalDevice-Network.com, 13 September 2024.
Researchers at Kings College London have built an AI model that can accurately predict who is at a high risk of developing sight-threatening diabetic retinopathy (DR) up to three years in advance. Image data from the UK’s National Health Service (NHS) was used to develop the tool, which can predict if someone is at low or high risk of developing sight-threatening DR in one year, two years or three years using images from the back of the eye.
To develop the new AI tool, researchers utilized over a million retinal images from diabetes patients. The model’s accuracy was validated using a dataset of 70,000 images from the INSIGHT health data research hub. INSIGHT is an NHS-led initiative housing retinal images linked to clinical data.
The NHS said that if implemented, this AI-based technique could reduce the screening burden for people at low risk of vision loss, while ensuring individuals at a high risk of vision loss are seen urgently, saving the NHS millions of pounds, and thousands of appointments every year.
Read more: NHS develops AI model to predict diabetic retinopathy
George Church’s lab raises $75M to develop ‘supercell’ medicines by Kristin Jensen for BioPharmaDive.com, 19 Septebmer 2024.
A new company born out of research done by top Harvard genetic scientist George Church is promising to “revolutionize cell therapy.” The company, GC Therapeutics, announced its launch with $75 million in financing from investors. Church’s startup is taking the work a step further by building what it says is the first complete collection of human transcription factors, which control and direct the genes in a cell. That collection forms the basis of GCTx’s technology, dubbed TFome, and it allows the company to run a faster and simpler process to differentiate cells.
GCTx claims it can produce its “SuperCell” therapies up to 100 times faster than with conventional methods used to create off-the-shelf cell therapy products. And the same starting point can be used for different cells aimed at varied diseases, yielding faster drug development, the company said. It has tested the approach “across diverse cell types” in initial preclinical work. GCTx is focused on induced pluripotent stem cells, which are derived from a person’s skin or blood cells and then reprogrammed so they can develop into any type of cell.
Read more: Startup from George Church’s lab raises $75M to develop ‘supercell’ medicines
SymbioCellTech’s Stem Cell-Enabled Therapy Could Offer a Functional Cure for Type 1 Diabetes Without Requiring Anti-Rejection Drugs by StartUpHealth.com.
In 2014, Anna Gooch, PhD and Christof Westenfelder, MD, a clinical nephrologist and expert in stem cell research and regenerative medicine who previously founded Allocure, came up with a hypothesis that could work with the body’s natural functions, rather than against them, if they could reduce islet cell therapy rejection, and make donor islet cells more readily available.
The SymbioCellTech team has had a successful pre-IND meeting with the FDA, which resulted in a request to do one more study using human cells, the final clinical product, in a suitable mouse model. Once they have their IND in hand, they’ll set up their human clinical trial, which they hope to have up and running in the second half of 2025.
Denied by Insurance? A Pharmacist Tells You How to Appeal by Diana Isaacs for T1DExchange.org, 18 September 2024.
Have you ever gone to the pharmacy only to find out your insurance doesn’t cover a medication that’s been ordered for you? It can be an incredibly frustrating process. One way to prevent this is to contact your insurance plan first to see what prescription drugs are preferred.
Write an appeal letter: here’s how: You and your healthcare team can take action by writing an appeal letter. An appeal letter can be written by you or your healthcare provider. You’ll need to include your full name, contact details, diagnosis and healthcare provider information, health insurance ID number, policy holder’s name and what was denied, the date of the denial, and the stated reason for it. Finally, you must communicate why you believe the medication should be covered. This is best done concisely and objectively. In other words, keep it short and to the point.
if you have a Medicare or Medicaid plan, the Consumer Assistance Program | CMS can help. Additionally, the National Association of Insurance Commissioners also offers a sample letter to request an internal appeal. Click on the links to learn more.
Try an AI tool to help format a letter: ChatGPT and other AI tools can be used as a starting point and be tailored to your unique situation. If you’re unsure of how to start, tools like ChatGPT can help design a template.
Read more: Denied by Insurance? A Pharmacist Tells You How to Appeal
USC launches large-scale nationwide study of type 1 diabetes and brain development by Keck School of Medicine of USC, 17 September 2024.
With a $2.7 million grant from the National Institutes of Health, researchers from the Keck School of Medicine of USC will lead a multi-site study to understand and optimize brain development in children with type 1 diabetes.
About half of adults with type 1 diabetes face significant cognitive impairment, including problems with working memory and executive function that affect day-to-day thinking. But less is known about how the condition affects children during a window of time known to be critical for healthy brain development.
A new large-scale longitudinal study, led by the Keck School of Medicine of USC, will unite 12 research centers across the United States to explore that important question. Researchers will collaborate to recruit a large, diverse group of children newly diagnosed with diabetes, taking a sweeping look at the environmental, lifestyle, social, and clinical factors that affect the way the brain develops. The five-year study is supported by a grant of more than $2.7 million from the National Institutes of Health.
Read more: USC launches large-scale nationwide study of type 1 diabetes and brain development
FTC and Major Pharmacy Benefit Managers: Who’s Suing Who?
FTC sues major pharmacy benefit managers over insulin prices by Rebecca Pifer for HealthCareDive.com, 20 September 2024.
The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs. The agency’s administrative complaint alleges CVS’ Caremark, Cigna’s Express Scripts and UnitedHealth’s Optum Rx steered patients toward higher priced insulin in order to bring in larger rebates from pharmaceutical manufacturers. As a result, patients who weren’t eligible for the lower discounted price faced higher costs, the FTC alleges. Caremark, Express Scripts and Optum Rx together control about 80% of U.S. prescriptions.
The companies have “abused their economic power by rigging pharmaceutical supply chain competition in their favor, forcing patients to pay more for life-saving medication,” the FTC said. The agency’s complaint hinges on how PBMs have negotiated discounts for insulin medications with drugmakers.
Read more: FTC sues major pharmacy benefit managers over insulin prices
Express Scripts sues FTC over report damning pharmacy benefit managers by Rebecca Pifer for HealthCareDive.com, 17 September 2024.
Cigna is following through on promises to more aggressively defend its pharmacy benefit manager. The healthcare company’s PBM, Express Scripts, sued the Federal Trade Commission over the agency’s recent report showing how the drug middlemen could be contributing to rising drug prices, calling the report “unfair, biased, erroneous, and defamatory.” The lawsuit asks a federal judge to order the FTC to withdraw the report, and recuse FTC Chair Lina Khan from further action against Express Scripts.
“We don’t take this step lightly, but … we cannot let the FTC’s unlawful actions and false information stand,” Andrea Nelson, Cigna’s chief legal officer, said in a statement.
Read more: Express Scripts sues FTC over report damning pharmacy benefit managers
Your GP could be using ChatGPT to diagnose you by Alex Hughes for ScienceFocus.com, 17 September 2024.
Artificial intelligence is seemingly everywhere. With the emergence of hundreds of tools and tricks powered by chatbots and large models, industries across the world are adopting it, including your local doctors. In a recent survey published in the journal BMJ Health & Care Informatics, it was found that one in five GPs are using AI. This is despite a lack of guidance or any clear work policies in place as of yet.
The research argues that both doctors and medical trainees need to be trained in the use, as well as the pros and cons, of AI before using it. There is a continued risk of inaccuracies (known as hallucinations), as well as algorithmic biases and patient privacy risks.
A random sample of GPs were sent a survey to complete. Each doctor was asked if they had ever used ChatGPT, Bing AI, Google Bard or any other AI service in their work. In total, 1006 GPs completed the survey. One in five respondents reported using generative AI tools in their clinical practice. Of these, more than 1 in 4 used the tools to generate patient documentation and a similar number said they used them to suggest diagnosis.
Of the AI tools mentioned in the study, ChatGPT was the most used by far, followed by Bing and Google Bard. However, of the 1006 replies that came in, the vast majority stated that they didn’t use any of these tools at work.
LOL, PBM’s suing the FDA. There must be something there.