About one-third of people with diabetes develop foot ulcers during their lifetime. In the U.S., more than 160,000 lower extremity amputations are performed annually due to complications from diabetic foot ulcers, costing the American health system about $30 billion a year. Those who have foot ulcers often die at younger ages than those without ulcers. CREDIT Courtesy UT Arlington
Researchers have developed a new shoe insole technology that helps reduce the risk of diabetic foot ulcers, a dangerous open sore that can lead to hospitalization and leg, foot or toe amputations.
“The goal of this innovative insole technology is to mitigate the risk of diabetic foot ulcers by addressing one of their most significant causes: skin and soft tissue breakdown due to repetitive stress on the foot during walking,” said Muthu B.J. Wijesundara, principal research scientist at The University of Texas at Arlington Research Institute (UTARI).
Affecting about 39 million people in the U.S., diabetes can damage the small blood vessels that supply blood to the nerves, leading to poor circulation and foot sores, also called ulcers. About one-third of people with diabetes develop foot ulcers during their lifetime. In the U.S., more than 160,000 lower extremity amputations are performed annually due to complications from diabetic foot ulcers, costing the American health system about $30 billion a year. Those who have foot ulcers often die at younger ages than those without ulcers.
“Although many shoe insoles have been created over the years to try to alleviate the problem of foot ulcers, studies have shown that their success in preventing them is marginal,” Wijesundara said. “We took the research a step further by creating a pressure-alternating shoe insole that works by cyclically relieving pressure from different areas of the foot, thereby providing rest periods to the soft tissues and improving blood flow. This approach aims to maintain the health of the skin and tissues, thereby reducing the risk of diabetic foot ulcers.”
In an article in the peer-reviewed International Journal of Lower Extremity Wounds, Wijesundara and UTA colleagues Veysel Erel, Aida Nasirian and Yixin Gu, along with Larry Lavery of UT Southwestern Medical Center, described their innovative insole technology. After this successful pilot project, the next step for the research team will be refining the technology to make it more accessible for users with varying weights and shoe sizes.
“Considering the impact of foot ulcers, it’s exciting that we may be able to make a real difference in the lives of so many people,” Wijesundara said.
Two siblings who have the only known mutations in a key gene anywhere in the world have helped scientists gain new insights that could advance the search for new treatments for type 1 diabetes.
Two siblings who have the only known mutations in a key gene anywhere in the world have helped scientists gain new insights that could advance the search for new treatments for type 1 diabetes.
Type 1 diabetes (also known as autoimmune diabetes) is a devastating and life-long disease in which the patient’s immune cells wrongly destroy the insulin-producing beta cells in the pancreas. People living with autoimmune diabetes need to test their blood sugar and inject insulin throughout their lives to control their blood sugars and prevent complications.
Autoimmune diabetes with clinical onset in very early childhood is rare and can result from a variety of genetic variants. However, there are many cases of early onset diabetes without known genetic explanation. In addition, some cancer patients treated with a category of immunotherapy known as immune checkpoint inhibitors — which target the same pathway that the mutation was found in — are prone to developing autoimmune diabetes. The reason why only this category of cancer immunotherapy can trigger autoimmune diabetes is not well understood. Like type 1 diabetes, genetic or immunotherapy-associated autoimmune diabetes requires life-long insulin replacement therapy — there is currently no cure.
The new research, published in the Journal ofExperimental Medicine, began when researchers studied two siblings who were diagnosed with a rare genetic form of autoimmune diabetes in the first weeks of life. The University of Exeter offers free genetic testing worldwide for babies diagnosed with diabetes before they are nine months old. For most of these babies, this service provides a genetic diagnosis and in around half of these babies, it allows for a change in treatment.
When researchers tested the two siblings in the study, no mutation in any of the known causes was identified. The Exeter team then performed whole genome sequencing to look for previously unknown causes of autoimmune diabetes. Through this sequencing, they found a mutation in the gene encoding PD-L1 in the siblings and realised it could be responsible for their very-early-onset autoimmune diabetes.
Study authorDr Matthew Johnson, from the University of Exeter, UK, said: “PD-L1 has been particularly well studied in animal models because of its crucial function in sending a stop signal to the immune system and its relevance to cancer immunotherapy. But, to our knowledge, nobody has ever found humans with a disease-causing mutation in the gene encoding PD-L1. We searched the globe, looking at all the large-scale datasets that we know of, and we haven’t been able to find another family. These siblings therefore provide us with a unique and incredibly important opportunity to investigate what happens when this gene is disabled in humans.”
The PD-L1 protein is expressed on many different cell types. Its receptor, PD-1, is expressed exclusively on immune cells. When the two proteins bind together it provides a stop signal to the immune system, preventing collateral damage to the bodies tissues and organs.
Researchers from the Rockefeller Institute in New York and King’s College London joined forces with Exeter to study the siblings, with funding from Wellcome, The Leona M. and Harry B. Helmsley Charitable Trust, Diabetes UK, and the US National Institutes for Health. After contacting the family’s clinician in Morocco, the Exeter team visited the siblings where they were living to collect samples and return them to King’s College London, within the crucial ten-hour window for analysis while the immune cells were still alive. The London and New York teams then performed extensive analysis on the siblings’ cells.
Study co-author Dr Masato Ogishi, from the Rockefeller University in New York, said: “We first showed that the mutation completely disabled the function of PD-L1 protein. We then studied the immune system of the siblings to look for immunological abnormalities that could account for their extremely early-onset diabetes. As we previously described another two siblings with PD-1 deficiency, both of whom had multi-organ autoimmunity including autoimmune diabetes and extensive dysregulation in their immune cells, we expected to find severe dysregulation of the immune system in the PD-L1-deficient siblings. To our great surprise, their immune systems looked pretty much normal in almost all aspects throughout the study. Therefore, PD-L1 is certainly indispensable for preventing autoimmune diabetes but is dispensable for many other aspects of human immune system. We think that PD-L2, another ligand of PD-1, albeit less well-studied than PD-L1, may be serving as a back-up system when PD-L1 is not available. This concept needs to be further investigated in the context of artificial blockade for PD-L1 as cancer immunotherapy.”
Study co-author Professor Timothy Tree, from King’s College London, said: “Through studying this one set of siblings – unique in the world to our knowledge – we have found that the PD-L1 gene is essential for avoiding autoimmune diabetes, but is not essential for ‘everyday’ immune function. This leads us to the grand question; ‘what is the role of PD-L1 in our pancreas making it critical for preventing our immune cells destroying our beta cells?’ We know that under certain conditions beta cells express PD-L1. However, certain types of immune cells in the pancreas also express PD-L1. We now need to work out the “communication” between different cell types that is critical for preventing autoimmune diabetes.
“This finding increases our knowledge of how autoimmune forms of diabetes such as type 1 diabetes develop. It opens up a new potential target for treatments that could prevent diabetes in the future. Simultaneously, it gives new knowledge to the cancer immunotherapy field by uniquely providing the results of completely disabling PD-L1 in a person, something you could never manipulate in studies. Reducing PD-L1 is already effective for cancer treatment, and boosting it is now being investigated as a type 1 diabetes treatment – our findings will help accelerate the search for new and better drugs.”
Dr Lucy Chambers, Head of Research Communications at Diabetes UK, said: “Pioneering treatments that alter the behaviour of the immune system to hold off its attack on the pancreas are already advancing type 1 diabetes treatment in the USA, and are awaiting approval here in the UK.
“By zeroing in on the precise role of an important player in the type 1 diabetes immune attack, this exciting discovery could pave the way for treatments that are more effective, more targeted and more transformational for people with or at risk of type 1 diabetes.”
Grocery stores, airports, and beaches aren’t great places for telehealth visits with your endocrinologist. But home can be one of the best locations. A doctor can gain helpful insights into a patient’s home environment, which can positively impact their care.
Researchers interviewed clinicians and staff who provide diabetes care through telehealth at four University of California academic medical centers: UC Davis Health, UCSF Health, UCLA Health, and UC San Diego Health. They asked open-ended questions to learn how telehealth is used, the challenges faced, helpful practices, and plans for the future.
“These are critical and timely questions since telehealth remains an important way to provide care in the wake of the COVID-19 pandemic. But there is limited data about how to optimize it for specific types of care,” said Stephanie Crossen, UC Davis pediatric endocrinologist and senior author of the study. “We asked the people who have the most experience in this area to identify best practices which can be used, further studied, and refined moving forward.”
The study suggests several important strategies to improve telehealth operations:
Dedicated staff support is essential to obtain data from patients’ devices (like remote glucose monitors) ahead of telehealth visits. This can improve access to care for individuals with limited digital literacy, save clinician time during visits and prevent unnecessary rescheduling of appointments.
Efficient workflows around scheduling follow-up visits are needed to ensure people don’t experience lapses in care.
Finding the best ways to facilitate team-based diabetes care is key. For a diabetes management telehealth visit, this may include a nurse, dietitian, social worker, pharmacist or educator, in addition to the primary clinician. It is important to create workflows that support this effort.
Interviewees also said telehealth visits can provide a good opportunity to review and discuss the impact of the home environment on diabetes self-care. Through screen sharing, clinicians can also review trends in a patient’s glucose data and discuss daily management successes or challenges.
Finally, those interviewed also noted the need for clear patient guidelines about appropriate timing and physical setting for joining telehealth visits to make them efficient and effective. For example, visits while driving or at a large group event were not advised.
“I hope the findings of our study will spark discussion around how we can optimize telehealth and take advantage of its unique capabilities to improve patient care, rather than trying to replicate the in-person visit,” said Sarah Haynes, assistant professor from the UC Davis Department of Pediatrics and lead author of the study.
Combining pelvic floor exercises with behavioural therapy could be more effective than current medical treatments at helping men with frequent urges to urinate, new research in men has found.
The results reveal that an app-based therapy significantly improves the lower urinary tract symptoms that many millions of men experience—hesitancy, straining, frequent urges to urinate, and effective bladder emptying. The full trial results are expected to be published later this year.
Carried out in Germany, this is the world’s first randomised controlled trial to look at combining pelvic floor training, behavioural therapy and bladder control techniques for mild, moderate and severe bladder emptying disorders in men, all delivered as an app-based therapeutic.
Bladder emptying disorders can start to appear from the age of 30 and typically affect a large proportion of men aged over 50.
While clinical guidelines recommend physiotherapy, behavioural therapy and lifestyle changes as a first-line treatment, clinicians often neglect them due to a lack of available evidence. Several unpleasant side effects are associated with the few drugs available, and surgery is only advised for those with severe symptoms.
Professor Christian Gratzke, from University Hospital Freiburg in Germany, who co-led the trial, explains: “Frequent urges to urinate and issues emptying the bladder are the most prevalent urinary conditions we see in men after urinary tract infections. While some drugs are available, they don’t tend to be effective, and up until now, there’s been little data available to back physiotherapy. We’re confident that we now have that data, and making this form of therapy available digitally could be a game changer for the millions of men who struggle day-to-day with issues emptying their bladder.”
The researchers recruited 237 men aged 18 across Germany into their 12-week study. Half the men were randomised to receive standard medical care, while the other half were given access to the Kranus Lutera app-based therapy alongside standard care. These participants were asked to record a urination diary, which was used to inform their treatment, and complete questionnaires about their symptoms’ severity and overall quality of life.
After 12 weeks, the trial found significant and clinically meaningful improvements in symptoms and quality of life measures from participants given the app-based therapy, who reported an average seven-point increase in symptom scores compared to those in the control group.
The study found that app-based therapy was more effective than medical therapy. No patients reported any side effects or challenges accessing the smartphone app.
The findings challenge the dogma of the 1980s and 1990s, when prostrate surgery was the first line of treatment for an overactive bladder, and offer a welcome alternative to drugs, say the researchers.
“Many men with bladder emptying disorders are ageing and have other medical conditions that require drug treatments,” says Professor Gratzke. “The limited drugs we have available aren’t suitable for these patients due to their side effects. For those with mild-to-moderate urinary symptoms, this digital therapy is without side effects and improves symptoms by a magnitude we have not seen before. Simply strengthening the pelvic floor makes all the difference, it’s a no brainer.”
Jean-Nicolas Cornu, Professor of Urology at the Charles Nicolle Hospital in France and member of the EAU Scientific Congress Office, said: “There has been little to no evidence to support training men to better control their bladders, despite this being recommended in clinical guidelines. This is the first randomised controlled trial looking at physiotherapy and behavioural therapy for bladder emptying disorders, and it shows a very positive effect over conventional drug treatment.
“We now need a bigger trial looking at the longer-term effect of this app-based therapy after 12 weeks for different forms of bladder emptying disorders. If offered widely, this treatment could dramatically change clinical practice, and could relieve symptoms without exposing patients to drugs. We could save a lot of unnecessary prescriptions for drugs that tend to be of little benefit.”
The researchers compared data from men whose symptoms were due to overactive bladder with those whose symptoms were due to an enlarged prostate. They found that both groups benefited from the therapy. However, it did not compare the effect of therapy on different forms of bladder emptying disorder.
Mass General Brigham study found earlier and greater medication uptake when a remote care team delivered simultaneous education and medication management compared to a period of education before medication management.
Researchers at Mass General Brigham tested a remote patient education and navigation program with 200 patients who had type 2 diabetes and elevated cardiovascular/kidney risk.
Patients who received education simultaneously with treatment were more likely to begin and adhere to treatment while a period of education before therapy initiation was inferior for prescription acceptance and therapy uptake.
The study highlights the importance of “striking while the iron is hot” and the potential for remote, team-based care to bridge healthcare gaps and enhance patient outcomes.
A new study by investigators from Mass General Brigham demonstrated that a remote team focused on identifying, educating and prescribing therapy can improve guideline-directed-medical-therapy (GDMT) adherence in patients with type 2 diabetes and high cardiovascular and/or kidney risk. The research team observed that patients who received education simultaneously with medication management demonstrated a higher rate of medication uptake and initiated treatment earlier compared to patients who received education over two months before medication management. Their results were presented at the 2024 American College of Cardiology’s Annual Scientific Session and simultaneously published in Circulation.
“Our results suggest that patients are more inclined to adhere to therapy when approached with education and treatment simultaneously and immediately,” said corresponding author Alexander J. Blood, MD, MSc, who presented the results. Blood serves as an attending physician in the Division of Cardiovascular Medicine and the Heart and Vascular Center at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system. “Providers should ‘strike while the iron is hot.’ If a patient is already interested in investing in their health and willing to meet with you, that’s the time to initiate treatment while providing educational resources.”
Type 2 diabetes, which increases an individual’s risk of cardiovascular and kidney events, affects millions of adults in the United States. Medications such as SGLT2 inhibitors and GLP-1 receptor agonists can improve cardiovascular and kidney outcomes in patients with type 2 diabetes, but data from clinical trials and society recommendations have not led to widespread adoption and utilization of these therapies.
To investigate the impact of patient education on prescription acceptance and therapy uptake, the research team conducted a parallel, randomized, open-label clinical trial. The study was funded by the Novo Nordisk Foundation. They enrolled 200 adult patients with type 2 diabetes at Mass General Brigham, who were at elevated risk of cardiac and/or kidney complications. Patients were randomly assigned to one of two groups. The “education-first” group received a dedicated two-month period of education, consisting of curated patient-centric videos on disease management and medication, prior to treatment initiation via an online portal. The second “simultaneous” group had access to the educational videos but received patient education concurrently with the initiation of their treatment.
Both groups received treatment through a research and clinical care management platform designed and created by the Accelerator for Clinical Transformation at Brigham and Women’s Hospital and Mass General Brigham, which facilitated care coordination among patient navigators, pharmacists, nurse practitioners and physicians. These healthcare professionals guided patients through every step of their engagement with health care and streamlined communication. The platform is part of Mass General Brigham’s larger efforts to transform healthcare delivery by helping patients access services and monitor health from home, especially at a time when hospitals are regularly operating over capacity.
Patients were followed for six months from enrollment or one month after medication initiation, whichever duration was longer.
While patients in both groups experienced benefits such as weight loss and reductions in blood glucose levels by the end of the study, those who received simultaneous education demonstrated a higher retention rate. Specifically, 60 percent of patients in this group were confirmed to have taken their prescribed therapy, compared to 44 percent in the “education-first” group. Additionally, contrary to initial predictions, patients in the “education-first” group did not engage more with the educational platform than those in the simultaneous group.
While the findings suggest that a pre-treatment education period may not be the solution to medication adherence issues, they underscore the potential of remote, team-based care delivery. This approach holds promise in facilitating the implementation of new therapies, bridging care quality disparities, and enhancing healthcare outcomes across diverse populations. The authors describe how the flexibility inherent in remote treatment may extend access to care, particularly benefiting traditionally underserved populations or individuals with busy schedules. Moreover, the inclusion of a patient navigation team fosters ongoing patient-provider communication, providing the personalized support necessary for sustained patient engagement in their care.
“We strongly believe that remote care programs that leverage non-licensed navigators, clinical pharmacists, and team-based care, together with a care delivery platform, will improve operational efficiencies and communication and thereby address many of the persistent problems in health care,” said Benjamin M. Scirica, MD, MPH, principal investigator of the DRIVE study and director of the Accelerator for Clinical Transformation. “On a broader scale, programs like this enhance access, elevate patient outcomes, reduce physician burden, and promote the appropriate utilization of guideline-recommended medications.”
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