Roundup: Safety Alert for Diabetics Using Smartphone-Compatible Devices; and More News

FDA issues Safety Alert for Those Using Smartphone-Compatible Diabetes Devices

The U.S. Food and Drug Administration (FDA) has issued a safety alert for patients who use smartphone-compatible diabetes devices such as continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems.

These devices rely on smartphones to deliver critical alerts, helping users manage their condition effectively. However, the FDA has raised concerns about some of these alerts not being delivered or heard, which could lead to serious health risks.

Diabetes devices often allow users to personalize settings for alerts, including frequency, volume, and the method of delivery (audible, vibration, or text-only). But the FDA has received reports from patients who believed they had set up their devices correctly, only to find that alerts were either missed or not delivered at all.

In some cases, this has led to cases of “serious harm” -- such as hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), diabetic ketoacidosis (DKA), and even death, the FDA states.. DKA develops when your body doesn't have enough insulin to allow blood sugar into your cells for use as energy.

Courtney Lias, director of In Vitro Diagnostic Products at the FDA’s Center for Devices and Radiological Health, emphasizes that while these devices offer convenience and flexibility, users must remain vigilant about their alert settings. “Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected,” she warns in a news release.

Common Reasons Why Alerts May Not Be Delivered

Several factors can interfere with the timely delivery of critical alerts, states the FDA:

1. Software Configuration Issues: App notification settings may be misconfigured, including “Do Not Disturb” or “Focus Mode” settings, or the app may enter “deep sleep” after being inactive for a period of time.
2. New Hardware Connections: Connecting new devices to the smartphone, such as car audio systems or wireless earphones, can change the volume or prevent the alerts from being heard.
3. Smartphone Operating System Updates: Updates to the phone’s operating system may not be compatible with the medical device app, affecting its functionality.

Key Recommendations for Diabetes Device Users

To avoid missing critical alerts, the FDA recommends that users of smartphone-based diabetes devices follow these precautions:

• Read the Instructions: Carefully follow the setup instructions provided by the device manufacturer, especially when installing or updating the medical app on your smartphone.
• Manage OS Updates: Turn off automatic updates for your phone’s operating system. Confirm that the diabetes device app is compatible with any new OS version before updating.
• Check Alert Settings After Changes: After updating the phone’s OS or connecting new accessories like wireless headphones, confirm that alert settings are correct. Monitor the device to ensure the alerts are both received and audible.
• Routine Checks: At least once a month, review your alert settings to ensure they are configured as expected.
• Contact Support: If you notice that alerts are not being received or cannot be heard, contact the device’s technical support team for assistance.
• Report Problems: If any issues arise with the diabetes device, report them to the FDA to help ensure the safety of other users.

The FDA states that it is actively working with manufacturers of diabetes-related medical devices to ensure that these devices are thoroughly tested and that alert systems are carefully evaluated before patients rely on them.

Learn about Diabetes Treatment Services at Baptist Health.

Electrocardiogram Tests and Artificial Intelligence: The Future of Detecting Cognitive Decline?

A new study suggests that electrocardiogram (ECG)tests – typically used to assess heart health – could be paired with artificial intelligence (AI) models to detect premature aging and cognitive decline.

These preliminary findings, set to be presented at the American Stroke Association's International Stroke Conference in Los Angeles this month, reveal a fascinating new way to potentially identify individuals at risk for cognitive impairment using a tool that is already common in heart and stroke diagnostics.

What is ECG Age?

An ECG, or electrocardiogram, records the electrical activity of the heart. It does this by capturing the electrical impulses generated every time the heart beats, translating them into wavy lines that doctors can interpret. These lines can reveal a range of heart-related issues, from arrhythmias to signs of heart disease.

But in this new study, researchers have found that an ECG test can do more than assess heart health—it can also provide insights into a person's biological age. Unlike chronological age, which simply counts the number of years a person has lived, biological age is a measure of how well the body’s cells and tissues are functioning.

An individual's biological age can be affected by various factors, including lifestyle, genetics, and environmental exposures. By analyzing ECG data, researchers can estimate this biological age—referred to as “ECG age”—which can offer clues about a person’s overall health status.

The Link Between ECG Age and Cognitive Decline

Previous studies have shown that ECG age can help predict heart disease and mortality. However, until now, little was known about its potential relationship with cognitive decline.

Led by Bernard Ofosuhene, a clinical research coordinator at UMass Chan Medical School in Worcester, Massachusetts, the study analyzed data from more than  63,000 participants in the UK Biobank, a long-term study of health and disease in the United Kingdom. By applying an AI model to participants’ ECG data, researchers were able to predict each person’s ECG age and then compare it with their cognitive performance. The results were telling.

People whose ECG age was older than their chronological age performed significantly worse on cognitive tests compared to those whose ECG age matched or was younger than their actual age. In fact, participants with accelerated ECG aging showed lower cognitive test scores, while those with decelerated ECG age performed better.

These findings suggest that a higher ECG age could be a sign of accelerated aging across the body—not just in the heart. Given that cognitive decline is often one of the most significant health issues as we age, identifying people with “older” ECG ages could serve as an early warning system, flagging individuals who may be at risk for developing dementia or other forms of cognitive impairment.

A New Tool for Early Detection

This AI-based method of predicting cognitive decline could revolutionize how we approach brain health, particularly in those at risk for stroke or heart disease. Mr. Ofosuhene notes that since ECGs are already commonly used to monitor heart health, this new application could be integrated into routine care. Health professionals could potentially use ECG tests to identify early signs of cognitive decline and intervene sooner, which may improve outcomes for patients.

While the findings are still considered preliminary, they open the door to a promising new approach to diagnosing and managing cognitive decline. However, future research will be needed to confirm these results in more diverse populations and to explore how factors like gender might influence the relationship between ECG age and cognitive health.

Too Many U.S. Adults Still in the Dark About Risks of Daily Aspirin Use, Survey Finds

For many years, doctors advised healthy older adults to take a daily low-dose aspirin to reduce the risk of heart attacks and strokes. However, the American College of Cardiology and the American Heart Association (AHA) updated their guidelines in 2019, no longer recommending routine aspirin use for adults over 70 due to the risk of gastrointestinal bleeding outweighing any potential benefits.

Despite these changes, many Americans still haven't caught up with the new recommendations. Everyone should consult with the doctor before taking aspirin on a regular basis.

A recent survey by the Annenberg Public Policy Center (APPC) at the University of Pennsylvania reveals a concerning disconnect. Nearly half of U.S. adults (48 percent) still believe that taking a daily low-dose aspirin is beneficial for most people, even though medical experts now advise against it for those without cardiovascular disease. The survey highlights how hard it can be to shake old health habits, especially when they’ve been ingrained for years.

The previous recommendation was based on the belief that low-dose aspirin—typically 81 mg—helps prevent blood clots, which can lead to heart attacks and strokes. While aspirin may still be effective for people with existing heart disease, the AHA and other health organizations have reassessed the risks for healthy individuals, particularly older adults, where the danger of bleeding outweighs the preventive benefits.

In 2022, the U.S. Preventive Services Task Force further reinforced this shift, advising against starting a low-dose aspirin regimen for adults aged 60 or older who don't have a history of heart disease or stroke. Despite this, the survey found that about 18 percent of adults with no personal or family history of cardiovascular issues continue to take aspirin daily. Many of these individuals may still be following outdated advice or simply haven't received updated information.

The survey results also show generational differences in understanding the risks of aspirin use. Among those aged 18-39, nearly 30 percent correctly recognized that the risks of daily aspirin outweigh the benefits. In contrast, only 7 percent of adults aged 60 and older shared this understanding, likely due to their familiarity with the previous guidelines. Older generations are more likely to hold onto habits shaped by years of medical advice.

Kathleen Hall Jamieson, director of the APPC, emphasized the importance of keeping up with evolving health guidance. "Understanding whether daily aspirin use is right for you is vital to making informed decisions about your health," Ms. Jamieson said in a news release. This underscores the need for clear communication about changing medical recommendations, especially when it comes to preventive care.

Patients with a personal history of heart attack or stroke may be directed to take a low-dose daily aspirin by their doctors. Those 40- to 59-year-olds who have a 10 percent or greater 10-year cardiovascular risk also may be directed to take aspirin, in line with the recommendations.