It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: an existing drug for arthritis is being studied for treatment of T1D, poison control centers report a big increase in calls about misdosing of Ozmepic and semaglutides, Tandem releases it’s Tandem Source software, we’ve got an update on a possible non invasive glucose monitoring system, ADA releases it’s standards of care and more!
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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.
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Our top story this week…
A world-first clinical trial has found a common drug used to treat rheumatoid arthritis can suppress the progression of type 1 diabetes in recently diagnosed patients. Australian reserachers say they’ve discovered that baricitinib *bare-uh-sit-en-ub* can preserve the body’s own insulin production.
The scientists recruited 91 people, aged between 10 and 30 years old, to take part in the double-blind randomised trial.
All patients had been diagnosed with type 1 diabetes within the last 100 days and continued with their prescribed insulin therapy throughout the study.
The results showed those in the baricitinib group were able safely and effectively to preserve their body’s own insulin production and suppress the progression of type 1 diabetes.
“Our trial showed that, if started early enough after diagnosis, and while the participants remained on the medication, their production of insulin was maintained.
“People with type 1 diabetes in the trial who were given the drug required significantly less insulin for treatment.”
Dr Faye Riley, research communications manager at Diabetes UK, said of the latest trial: “These findings show by tackling the root of type 1 diabetes – an immune system attack – an existing drug can help to shield the pancreas, in people recently diagnosed with type 1, so they can continue making more insulin for longer.
“This can give people with type 1 diabetes much steadier blood sugar levels and help to protect against serious diabetes complications down the line.
“Immunotherapies are edging us towards a new era in type 1 diabetes treatment, and could help us overcome a major hurdle en route to finding a cure for the condition.
“This trial takes us another step closer.”
The study was funded by JDRF, a non-profit organization which focuses on type 1 diabetes research.
The research has been published in the New England Journal of Medicine.
Earlier this month, Dexcom’s G7 became compatible with two pump systems: Beta Bionic’s ilet pump and Tandem Diabetes tslim X2. Current customers should have received instructions on how to download the updated software – new pumps will be shipped with G7 software already loaded.
Tandem has also announced their new Tandem Source platform – full launch in the US with international rollout slated for next year. Anyone in the U.S. who uses a Tandem pump—as well as their respective healthcare providers—will now have access to the Source platform. On the patient side, insulin dosage data will automatically transfer from the pump to the platform, by way of the t:connect mobile app, where it’ll be compiled into three reports for your doctor. Patients will also be able to use the platform to access new software updates for their pumps and to reorder supplies as needed.
Long term, the company hopes to use the data from users – which would be blinded- to update automated insulin dosing algorithms.
New look at benefits from a plant based diet – this research says it can reduce the risk of type 2 diabetes by 24%. It’s not just about weight loss. They reviewed data on more than 113,000 participants in a large-scale British observational study, gathered over 12 years. They found that normal values for cholesterol, blood sugar, inflammation, and insulin are associated with a low risk of diabetes. They also found that good liver and kidney function is important in diabetes prevention. A plant based diet helped with all of those factors. The researchers do point out that there is such a thing as an unhealthy plant-based diet. Those that are still high in sweets, refined grains and sugary drinks are associated with an increased risk of type 2 diabetes, researchers found.
Reports of more patients with type 2 diabetes having trouble getting coverage for medication like Ozempic and Mounjaro – because health insurance companies are putting new restrictions in place.
Most U.S. health plans cover GLP-1s for type 2 diabetes but many providers will prescribe it off label for weight loss. There is another medication – Wegovy – approved for weight loss, it’s the same drug as Ozempic just packaged in a difference dose and name.
The average number of weekly Ozempic prescriptions rose 33% between the first and third quarters of this year, but has since dropped more than 6% to about 431,000, according to Iqvia Institute for Data Science.
Doctors and patients are bracing for changes in January, when individual health plans often set new coverage terms.
“It may be that January 1, all of a sudden something that was covered is no longer,” said Dr. Robert Gabbay, chief science officer at the American Diabetes Association.
Poison control centers across the US say they are seeing a steep increase in calls related to semaglutide, with some people reporting symptoms related to accidental overdoses. From January through November, the America’s Poison Centers reports nearly 3,000 calls involving semaglutide, an increase of more than 15-fold since 2019. In 94% of calls, this medication was the only substance reported.
The compounded versions of semaglutide are often different from the patented drug. Many contain semaglutide salts called semaglutide sodium and semaglutide acetate. The FDA says the salt forms of the drug have not been tested and approved to be safe and effective the way the patented form of the medication has, and thus they don’t qualify for the compounding exemption in the law for drugs in shortage. In other cases, the compounded versions are sold in unapproved dosages.
But these compounded versions are popular because they may cost less out-of-pocket, especially if the treatment isn’t covered by insurance.
The name-brand drugs are sold in pre-filled pens, which come with some safeguards. Patients dial to the correct dose and click to inject, so it’s harder to make mistakes. Compounded versions, however, typically come in multidose glass vials, and patients draw their own doses into syringes. It’s easy to get confused.
Type 2 diabetes patients who received endocrinology care through telehealth alone had poor glycemic outcomes compared with those who received in-person or hybrid care, which contrasts with prior research findings, according to a new study.
Previous research has shown that telehealth is effective in improving glycemic control, but there has not been enough data on utilization and outcomes linked to routine telehealth care for type 2 diabetes since 2020, especially in the endocrinology setting, the researchers wrote.
One reason may be that the strategies to support glycemic improvement deployed during in-person appointments, like self-management education and sharing home blood glucose data, have not been consistently translated to telehealth.
“Implementation of approaches to overcome these differences, such as team-based virtual care and technological tools to automate blood glucose data sharing, are needed to ensure all patients receive high-quality diabetes care regardless of care modality,” they wrote.
These study findings contrast with previous research, including a study published in early 2022 that revealed that telehealth maintained quality of care and led to better health outcomes for patients with type 2 diabetes during the COVID-19 pandemic.
The study included 16,588 with type 2 diabetes who received care before or during the pandemic, with 7,581 having a telehealth visit with either a primary care physician or an endocrinologist.
Medtronic’s deal to buy a South Korea based insulin patch pump maker is off. Back in May Medtrnoic announced a 738-million dollar deal to buy EOFlow, which makes EOPatch, a tubeless, wearable and fully disposable insulin delivery device.
EOFlow already launched its EOPatch insulin delivery system in Korea and Europe. The company submitted the insulin delivery device for U.S. FDA clearance in January.
Update on non invasive continuous glucose monitoring.
The most recent validation of the technology’s accuracy has been released as a preprint. In an experiment, researchers fed thousands of radio frequency glucose readings into a machine learning model to translate them into blood sugar values and compared the results against those from a Dexcom G6.
CGM accuracy is judged by mean absolute relative difference, or MARD. The statistic is reported as a percentage: a MARD of 10 percent, for example, means that the CGM is on average within 10 percent of the reference value. The Bio-RFID system scored a MARD of 11.27 percent.
In truth, this result is difficult to interpret. Though Bio-RFID’s MARD is not yet in the same neighborhood as its competitors’ (the Freestyle Libre 3 and the Dexcom G7 report MARDs of 7.9 percent and 8.7 percent, respectively), the experiment wasn’t a true test of the device’s capabilities, because it didn’t use a lab-drawn glucose measurement as its reference value. The volunteers also did not have diabetes, which meant that their blood sugar levels were likely more stable than those of most future customers.
The FDA has specific accuracy standards that it expects CGM manufacturers to meet for devices intended for “nonadjunctive” use and for use in a closed-loop insulin pump system. Know Labs’s product will need to meet these objective standards to be validated as a truly reliable CGM.
The Path to Approval
“Our expectation is that we’ll be in front of the FDA as we move into the second half of 2024,” says Erickson. Much larger trials will be needed to show that the device works and meets FDA standards. Erickson says, “We expect to have an FDA-cleared device in 2025.”
Though the business is still finalizing the form of the next generation, it expects that it can navigate the FDA approval process quickly. The FDA has already confirmed that RFID is quite safe and there should be little worry about side effects (though there could be a hazard of interference for patients already using electronic medical devices such as pacemakers).
Today, the American Diabetes Association® (ADA) released the Standards of Care in Diabetes—2024 (Standards of Care), a set of comprehensive and evidence-based guidelines for managing type 1, type 2, gestational diabetes, and prediabetes based on the latest scientific research and clinical trials. It includes strategies for diagnosing and treating diabetes in both youth and adults, methods to prevent or delay type 2 diabetes and its associated comorbidities like cardiovascular disease (CVD) and obesity, and therapeutic approaches aimed at minimizing complications and enhancing health outcomes.
“The latest ADA guidelines present pivotal updates for health care professionals, ensuring comprehensive, evidence-based care for diabetes management. These changes reflect our ongoing commitment to optimizing patient outcomes through informed, adaptable, and patient-centered health care practices,” said Robert Gabbay, MD, PhD, the ADA’s chief scientific and medical officer. “The ADA’s Standards of Care ensures health care professionals, especially our primary care workforce, provide the best possible care to those living with diabetes.”
Notable updates to the Standards of Care in Diabetes─2024 include:
New updates in managing obesity in people with diabetes, including approaches to reduce therapeutic inertia, support more personalization, and incorporate additional obesity measurements beyond body mass index (i.e., waist circumference, waist-to-hip ratio, and/or waist-to-height ratio).
New screening recommendations for heart failure in people with diabetes.
Updated recommendations for peripheral arterial disease (PAD) screening in people with diabetes.
Guidance on screening and the use of teplizumab, approved to delay the onset of type 1 diabetes.
More guidance on the use of new obesity medications, glucagon-like peptide 1 (GLP-1) agonists or dual glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, to reach sustained weight management goals.
Updates in guidance on the diagnosis and classification of diabetes.
A focus on hypoglycemia prevention and management.
Emphasis on screening people with diabetes for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis at primary care and diabetes clinics.
New emphasis on the evaluation and treatment of bone health and added attention to diabetes-specific risk factors for fracture.
A focus on screening and management of people with diabetes and disability.
Emphasis on enabling health care providers to master diabetes technology, using artificial intelligence for retinal screenings with necessary referrals, and embracing telehealth and digital tools for diabetes self-management education.
New information on the possible association between COVID-19 infections and new onset of type 1 diabetes.
“As the ADA’s chair of professional practice committee, I’m excited to share our latest updates to advance diabetes care through new scientific insights and technological innovation, all aimed at enhancing experience for people with diabetes and health care professionals in managing this complex condition,” said Nuha A. El Sayed, MD, MM Sc, the ADA’s senior vice president of health care improvement.
Other noteworthy changes to the 2024 Standards of Care include:
Updated immunization guidance to include newly approved RSV vaccines in adults over 60 years of age with diabetes.
New emphasis on cultural sensitivity in diabetes self-management education, with considerations for changing reimbursement policies.
More detail and emphasis on psychosocial screening protocols to better identify diabetes distress.
The importance of diabetes technology, with an emphasis on continuous glucose monitors (CGMs) and automated insulin delivery (AID) systems.
Continued emphasis on inclusion and person-centered care.
“At the ADA, we are focused on improving the quality of care for anyone who lives with diabetes, prediabetes, or who is at risk of developing diabetes. The Standards of Care is critical to ensuring the improved treatment of diabetes, a chronic disease that requires continuous care through a well-informed and coordinated health care team. These standards equip health care professionals with the gold standard in diabetes care, ensuring the highest level of service and knowledge in the field,” said Chuck Henderson, the ADA’s chief executive officer.
The ADA annually updates its Standards of Care through the efforts of its Professional Practice Committee (PPC). Comprising 21 global experts from diverse professional backgrounds, the PPC includes physicians, nurse practitioners, certified diabetes care and education specialists, registered dietitians, pharmacists, and methodologists. Its members hold expertise in areas like adult and pediatric endocrinology, epidemiology, public health, cardiovascular risk management, kidney disease, microvascular complications, preconception and pregnancy care, weight management, diabetes prevention, behavioral and mental health, inpatient care, and technology in diabetes management. Additionally, the committee collaborates with 19 specialized content experts. The 2024 Standards of Care has garnered endorsements from the American College of Cardiology (Section 10), the American Society of Bone and Mineral Research (Bone section in Section 4), and the Obesity Society (Section 8).
Today, the Standards of Care in Diabetes—2024 is available online and is published as a supplement to the January 2024 issue of Diabetes Care®. A shortened version of the guidelines, known as the Abridged Standards of Care, will be made available for primary care providers in the journal Clinical Diabetes®, along with a convenient Standards of Care app as well as a Standards of Care pocket chart. The online version will be annotated in real-time with necessary updates if new evidence or regulatory changes merit immediate incorporation through the “living” Standards of Care process. Other Standards of Care resources, including a webcast with continuing education (CE) credit and a full slide deck, can be found on the ADA’s professional website, DiabetesPro®.
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