Savvy Updates 2/17/25: 1st Rapid-Acting Biosimilar Insulin Approved, UVa AI-Powered Insulin Delivery, Susvimo for Diabetic Macular Edema, Oral Insulin Prevention Trial, GLP-1 Agonists Adhesive Capsulitis D, Protein-Rich, Low-Carb Diet & RA, D & Gum Disease & Flossing, Bone-Derived Hormone DKD, Insulin Resistance Predict OA, aD & Antibiotic-Resistance to Staph, ScotteVest & LOTS of POCKETS

In this week’s issue of The Savvy Diabetic:

- 1st Rapid-Acting Biosimilar Insulin Approved
- UVa AI-Powered Insulin Delivery
- Susvimo for Diabetic Macular Edema
- Oral Insulin Prevention Trial (PDF)
- GLP-1 Agonists Increased Risk of Adhesive Capsulitis in Diabetes
- Protein-Rich, Low-Carb Diet & RA
- D & Gum Disease & Flossing
- Bone-Derived Hormone DKD
- Insulin Resistance Predicts OA
- D & Antibiotic-Resistance to Staph
- ScotteVest & LOTS of POCKETS (video)

FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes by Kristen Monaco for MedPageToday.com, 14 February 2025.

The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes. Like its reference counterpart, insulin aspart (Novolog), the biosimilar helps lower mealtime blood sugar spikes to improve glycemic control. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.

“For the millions of people who rely on daily injections of insulin for the treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications,” said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research (CDER), in a statement.

New UVA clinical trial explores AI-powered insulin delivery for better diabetes care from University of Virginia School of Data Science and reported by Eurekalert.org, 11 February 2025.

A new clinical trial at UVA is aiming to simplify diabetes management by testing an innovative AI-powered device designed to improve automated insulin delivery. The trial is co-led by several School of Data Science faculty, including Assistant Professor of Data Science Heman Shakeri; Boris Kovatchev, founding director of the UVA Center for Diabetes Technology, a professor at the School of Medicine and professor of data science (by courtesy); and Anas El Fathi, research assistant professor at the Center for Diabetes Technology and assistant professor of data science (by courtesy).

The trial, kicking off in March, will evaluate a new reinforcement-learning feature called the “Bolus Priming System with Reinforcement Learning” (BPS_RL). The fully automated BPS_RL technology integrates with the existing Automated Insulin Delivery Adaptive NETwork (AIDANET) — a system comprising a phone app, Dexcom glucose monitor, and Tandem insulin pump — to enable insulin delivery without requiring user input.

The goal? To see if this new feature can help people maintain better blood sugar control, particularly during meals and overnight, while maintaining health safety and improving ease of use.

Susvimo Approval Expanded to Include Diabetic Macular Edema by Diana Ernst for EndocrinologyAdvisor.com, 6 February 2025.

The Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) for the treatment of patients with diabetic macular edema (DME) who have previously responded to at least 2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor medication. Susvimo is indicated for intravitreal use via the Susvimo ocular implant. The implant is surgically inserted during a one-time outpatient procedure and provides continuous release of ranibizumab, a VEGF inhibitor, with refills administered every 24 weeks (approximately 6 months).

“Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development for Genentech.

Read more: Susvimo Approval Expanded to Include Diabetic Macular Edema

Presentation: Oral Insulin Prevention Trial by Dr. Jay Skylar and Professor Ake Lernmark for Innodia.eu, 11 February 2025.

INNODIA started as a global partnership between 31 academic institutions, 6 industrial partners, a small-sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: “To fight type 1 diabetes”.

The project ran under the framework of the Innovative Medicines Initiative – Joint Undertaking (IMI-JU) with a dedicated governance structure ensuring close interaction, communication and adherence to the objectives and deliverables of the consortium. Importantly, INNODIA has closely been guided by the patients themselves, through the Patient Advisory Committee, consisting of a group of type 1 diabetes patients and parents, giving continuous feedback on the concept of INNODIA and the development of protocols.

Drs. Skylar and Lernmark presented Oral Insulin for Prevention of Relatives at Risk for Type 1 Diabetes Mellitus.

GLP-1 agonists may increase adhesive capsulitis risk in patients with diabetes by Max R. Wursta for Healio.com/orthopedics, 11 February 2025.

Among patients with type 2 diabetes, use of GLP-1 agonists may increase the risks for adhesive capsulitis and required surgical intervention, such as manipulation under anesthesia, according to published results. Victoria E. Bergstein, BA, medical student from the department of orthopedic surgery at Johns Hopkins University, and colleagues noted previous literature indicates an increased prevalence of adhesive capsulitis in patients with diabetes.

“The pathophysiology is thought to be related to diabetes mellitus-mediated pathogenic microvascular and macrovascular changes in the shoulder,” Bergstein and colleagues wrote in the study. “These chronic changes can lead to extracellular matrix protein synthesis, thickening of the capillary basement membrane, and inflammation-mediated fibroblastic proliferation, ultimately resulting in fibrotic contracture of the glenohumeral joint capsule and adhesive capsulitis.”

Overall, Bergstein and colleagues found patients who were taking GLP-1s were more likely to develop adhesive capsulitis compared with patients who were not taking GLP-1s. “These results can be useful when counseling [patients with type 2 diabetes] who develop adhesive capsulitis while taking GLP-1s to better inform these patients of the increased chance of requiring more extensive treatment,” Bergstein and colleagues concluded.

Protein-Rich, Low-Carb Diet Associated With Reduced Odds of Rheumatoid Arthritis by Rajan Saha for EndocrinologyAdvisors.com, 11 February 2025.

Higher low-carbohydrate diet (LCD) scores, characterized by reduced carbohydrate intake and increased protein consumption, are associated with a lower likelihood of rheumatoid arthritis (RA) among adults in the United States, according to study results published in Clinical Rheumatology.

Growing evidence suggests that diet, particularly macronutrient balance, plays a role in modifying RA risk and progression. However, prior research on the relationship between carbohydrate intake and RA has produced mixed findings, highlighting the need for further investigation into dietary patterns and their impact on RA outcomes.

“Given the association shown between the presence of RA and macronutrient consumption, more research is necessary to determine whether a high-protein, low-carbohydrate diet may lower the possibility of developing RA,” the study authors concluded.

Gum Disease and Diabetes by Anna Vidovszky & Cheryl Alkon for diaTribe.org, 3 February 2025.

Diabetes increases the risk of gum disease by raising blood sugar levels, which contributes to plaque buildup. Gum disease progresses through stages, from gingivitis (reversible with good hygiene) to periodontal disease, which can cause irreversible damage to the gums. Preventing gum disease involves regular dental checkups, maintaining good oral hygiene at home, managing blood sugar levels, and seeking treatment early to avoid severe complications. One-third of people with diabetes have severe gum disease, and the American Dental Association suggests that one in five cases of tooth loss is related to diabetes.

People with diabetes may have high blood sugar, which can increase the amount of glucose in their saliva. This glucose feeds bacteria in the mouth and combines with food to cause a buildup of plaque. Without regular daily brushing and flossing, this plaque can harden into tartar, which can only be removed by a dental professional. High blood sugar can also lead to dry mouth, which reduces the saliva flow needed to wash away food particles and bacteria.

Diabetes can also cause blood vessels to narrow, which reduces blood flow to the gum tissue and makes it harder to fight off infections. The inflammation caused by gum disease can also lead to high blood sugar, making diabetes management more difficult.

Read more: Gum Disease and Diabetes

MORE on YOUR TEETH: Be good to your teeth: Regular flossing reduces risk of stroke, AFib by Michael Walter for CardioVascularBusiness.com, 4 February 2025.

Adults who regularly floss their teeth may be significantly decreasing their risk of stroke or heart rhythm issues, according to new findings to be presented at the American Stroke Association’s International Stroke Conference 2025.

Overall, flossing at least once per week was associated with a 22% lower risk of ischemic stroke, a 44% lower risk of cardioembolic stroke and a 12% lower risk of AFib. Flossing more often appeared to lead to more significant risk reductions. The difference in AFib risk was unexpected, surprising researchers.

“Oral health behaviors are linked to inflammation and artery hardening,” lead author Souvik Sen, MD, MS, MPH, a vascular neurology specialist with Prisma Health Richland Hospital and the University of South Carolina School of Medicine, said. “Flossing may reduce stroke risk by lowering oral infections and inflammation and encouraging other healthy habits. Many people have expressed that dental care is costly. Flossing is a healthy habit that is easy to adopt, affordable and accessible everywhere.”

Bone-Derived Hormone Predicts Diabetic Kidney Disease Risk by Javed Choudhury for MedScape.com, 12 February 2025.

In patients with diabetes, serum fibroblast growth factor 23 (FGF23) levels may be an independent biomarker for early detection of diabetic kidney disease (DKD) and may improve the predictive performance of the recommended annual DKD screening measures, estimated glomerular filtration rate (eGFR) and albumin-to-creatinine ratio (ACR).

Elevated levels of FGF23, a bone-derived hormone, are related to disordered bone metabolism and the progression of chronic kidney disease in people with diabetes. FGF23 levels were elevated at baseline in patients with DKD, elevated in the early stages of incident DKD, and increased with DKD severity, but no significant changes were noted in serum calcium and phosphorus levels.

“Our study reveals an early and gradual increase in serum FGF23 levels during the course of DKD, suggesting that FGF23 could serve as a reliable independent biomarker for DKD risk prediction,” wrote the authors, who also noted its clinical potential for early identification of DKD in primary care and low-resource settings.

‘Alternative’ markers of insulin resistance can predict osteoarthritis by Justin Cooper for Healio.com/sheumatology, 10 February 2025.

Surrogate measures of insulin resistance, based on the triglyceride-glucose index, can be used to predict the development of osteoarthritis, according to data published in Scientific Reports.

“Previous studies have drawn a link between OA and metabolic syndrome (MetS), which is characterized by hypertension, hyperglycemia, dyslipidemia, and abdominal obesity,” Youmian Lan, of the First Affiliated Hospital of Shantou University Medical College, in China, and colleagues wrote.

Alternative markers derived from blood glucose and lipid profiles, as well as specific anthropometric measurements, such as the visceral adiposity index (VAI), lipid accumulation product (LAP), and triglyceride-glucose index (TyG), are increasingly employed as simple and effective tools for identifying insulin resistance.

Diabetes can drive antibiotic resistance to staph by Susan Kreimer for UPI.com, 12 February 2025.

People with diabetes are more prone to developing Staphylococcus aureus, a leading cause of infections and death associated with resistance to antibiotics, a new study has found. The findings were published in Science Advances.

An interaction between bacteria and diabetes could be a major force fueling the swift evolution and spread of antibiotic resistance, the researchers said. Staph is the most widespread bacterial infection among individuals with type 2 diabetes, a chronic condition that impairs blood sugar control and decreases the body’s ability to combat communicable diseases.

“Diabetes and antibiotic resistance are two major and growing problems worldwide,” study senior co-author Brian Conlon, an expert on antibiotic treatment failure and an associate professor in the Department of Microbiology and Immunology at the University of North Carolina-Chapel Hill, said. “Antibiotic resistance evolves rapidly in diabetics,” he added. “This further emphasizes the importance of controlling insulin in diabetics during infection. It may be useful to take a personalized medicine approach to prescribe antibiotics differently — more than one antibiotic, for example — in diabetics,” he added.

COOL PRODUCTS: ScotteVest is an interesting site that offers clothing, ALL WITH POCKETS!

SCOTTeVEST is not your ordinary clothing company. All their garments feature specially designed pockets and features to make our lives, as people with diabetes, easier. Features include:

- - RFID Blocking Pocket: Keep your passport and credit cards safe from high-tech skimmers
  - Computer Pocket: Store bigger items with ease. Fit a full-size tablet or small laptop
  - Weight Management System: Our pockets are designed for even distribution and all-day comfort.

Co-founders, Laura & Scott Jordan designed great-looking clothing with tons of innovative pockets and unique features. How great to stash all your diabetes gear and other stuff, as you navigate your lives and travel the world. Scott is also the author of Pocket Man: The Unauthorized Autobiography of a Passionate, Personal Promoter He was featured on Shark Tank in one of the most controversial episodes Shark Tank: Season 3, Episode 7 with a battle with Mark Cuban, a call to Steve Wozniak (Apple Computers co-founder) … and Scott walking out with a $1million offer on the table … it’s apparently quite a story!

I want one! Might buy one for my husband, who carries a lot of junk in his pockets. The company offers a 15% welcome discount for new customers (but you have to provide your email address to get it. This sign-up is on the site when you first visit – and an email with a unique code gets delivered as soon as you sign up! If you do not want future emails, you can unsubscribe after you order.

Their Slogan: It’s NOT Rocket Science! It’s POCKET SCIENCE!

(BTW, it’s a fun website to browse … check out the About Us section)

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