Diabetes device data may fail to deliver based on smartphone settings

From contemporarypediatrics.com

The FDA is warning diabetes patients that information from CGMs, insulin pumps, and automated dosing systems could fail to be delivered if smartphone settings are not properly configured 

In a new FDA alert, the agency is warning diabetes patients who use devices such as smartphones, continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems, that smartphone settings could hinder delivery of critical safety alerts that come from such devices.

Many diabetes devices depend on smartphone connectivity to delivery safety alerts to the patients using them. Smartphone settings determine which alerts to receive, how often, and how alerts are delivered to the smartphone, such as via text, vibration, or with an audible sound. This is typically done through the device's app on the phone.

The federal agency has received medical device reports that stated alerts are not being delivered or not being heard, in cases where the users thought they had configured the settings correctly. In some cases, the FDA stated, these missed alerts could have contributed to serious harm such as hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and death.

In the announcement, Courtney Lias, who is the director of the Office of In Vitro Diagnostic Products within the FDA's Center for Devices and Radiological Health, said a regular monitor of these settings can help mitigate missed alerts.

"Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them. However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected," said Lias.

It is important to remind patients that even routine smartphone updates can have a potential impact on notification delivery.

"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," added Lias.

The FDA identified the following hardware and software changes and updates, among other reasons, that could lead to critical alerts not being delivered as intended:

• Software configuration issues, such as app notification permissions, using “do not disturb” or “focus mode” or the app entering “deep sleep” after a period of not being used;
• Connecting new hardware to the smartphone, such as connecting to car audio or using wireless earphones, that can change the default volume of alerts or prevent delivery of alerts; and
• Smartphone operating system updates that are not supported by the medical device application.

Recommendations, from the FDA's safety communication guide, for users of these devices include:

• Carefully follow the instructions provided by diabetes device manufacturers when installing, setting up or updating mobile medical apps on the smartphone;
• Turn off automatic operating system (OS) updates to the smartphone and do not update the phone’s OS until confirming the diabetes device app is compatible with the new OS version;
• After updating the phone’s OS or adding a new accessory, such as wireless headphones, confirm alert settings then carefully monitor the medical device app to make sure alerts are received and can be heard as expected;
• At least once a month, check that the smartphone alerts are configured as expected;
• If alerts are not being received as expected from the mobile medical app, or cannot be heard, call the technical support number for the medical device for assistance; and
• Report any problems with the diabetes device to the FDA.

The federal agency stated in the alert that it is working with diabetes-related medical device manufacturers "to ensure that smartphone alert configurations of their devices are carefully evaluated prior to use by patients. The agency is also working with manufacturers to ensure that settings in smartphones and mobile medical apps that may impact safety alerts are continuously tested and any updates to recommended configurations are communicated quickly and clearly to users."

Reference:

FDA alerts patients of potential to miss critical safety alerts due to phone settings when using smartphone-compatible diabetes devices. FDA. Press release. February 5, 2025. https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-potential-miss-critical-safety-alerts-due-phone-settings-when-using-smartphone

https://www.contemporarypediatrics.com/view/fda-smartphone-compatible-diabetes-devices-could-fail-to-deliver-safety-alerts

Can apps really help with diabetes management?

From patient.info

Technology often plays a big part in how we manage our health. We use fitness trackers to log how much exercise we do. Calorie counters help us keep on top of our snacking habits - and we even use apps to help support our mental well-being. Tech can also support us when managing more specific health conditions like diabetes. But how do these apps work - and can they really help?

"For many people living with all types of diabetes, apps can be a huge help in supporting their self-management, helping with carbohydrate counting, blood glucose tracking and diabetes education," says Dan Howarth, head of care at Diabetes UK.

"Several apps allow people with diabetes to automatically share information with their healthcare teams, which has been particularly useful during the pandemic. There are also many apps being used by people at risk of developing type 2 diabetes, to support their weight loss."

Why apps can help with diabetes management

Diabetes is a condition which causes a person's blood sugar level to become too high. There are two different types. In type 1 diabetes, the body's immune system attacks and destroys the cells that produce insulin. Therefore, the body is unable to produce enough insulin to adequately regulate blood glucose levels. People with type 1 diabetes must take insulin daily and monitor their blood sugars to ensure appropriate dosing.

In type 2 diabetes, the body can no longer respond effectively enough to its own insulin to prevent blood glucose levels from going too high. However, unlike type 1 diabetes, you can take action to get your body to respond better to insulin. Type 2 diabetes is complex and management can vary: while it always includes lifestyle changes, drug options include tablets, injectable therapies and insulin.

It can be hard to keep on top of diabetes management when you're busy, but apps can help with everything from medication and GP appointments to diet and exercise. "Diabetes is a relentless condition, and when combined with the stresses of everyday life, for many, managing their diabetes can easily become a second priority," says Howarth.

"There is so much to remember when trying to manage diabetes, so it's understandable that things may sometimes get missed. The important thing is to discuss with your healthcare team how to overcome ongoing concerns and find the routine that works for you."

Keeping track of diet and exercise

There are a huge number of different apps to help track your diet and log your exercise, which can seem overwhelming. However, using tech to monitor your progress can be motivating when things seem tough.

The MyDiabetes app is an app for people with diabetes and diabetes-related issues such as high blood sugar, excess weight and high cholesterol. With over 150,000 members, it provides personalised diabetes management and weight loss advice, including plans created by nutritionists to help you create and maintain a healthy diet. It is suitable for people with type 1 or type 2 diabetes, as well as pre-diabetes and less common types of diabetes such as latent autoimmune diabetes of adults (LADA).

The MyDiabetes app helps you to transition to a moderate-carb diet with a personalised meal plan (adapted for you over time) that covers your calorie and carb/sugar intake as well as your macronutrient composition. It also allows you to log your blood glucose and HbA1c levels, weight and medications; to track your progress; offers 5- to 15-minute exercise workouts to build up your physical activity; and includes educational videos via the MyDiabetes Academy.

The Low Carb Program, which is free if you are given an access code by your GP or nurse, is a platform available in the UK that helps you make lifestyle changes that can improve your health. You can personalise the information you receive. The app covers sleep, stress, mental health, blood glucose testing, cholesterol and stopping smoking, as well as recipes and meal plans for weight loss.

Changing Health is another app for people aged over 18 who have type 2 diabetes, which you can access following a referral from your GP. It helps you manage your physical activity, diet and weight.

Managing insulin, medication and blood glucose

With so much going on in our lives, it can be easy to forget to take medications or attend appointments. However, it's important to take your medications, injections or treatments when necessary to avoid complications.

If insulin injections or medications are missed, complications can include hypoglycaemia - blood sugar levels which are too low - and ketoacidosis - a serious complication that occurs when your body produces high levels of blood acids called ketones. Longer-term complications include heart disease, stroke, kidney disease and eye problems, which can potentially lead to loss of vision.

The thought of injecting each day can be daunting, but once you get the hang of it, it becomes a manageable part of life. Apps can make managing insulin easier by allowing you to log when you have taken your medication, set reminders and check your blood glucose.

You can track your progress and activity, access workouts, find meal plans and create shopping lists to help you stay on track with your diet.

The Mumoactive app is one option for tracking type 1 diabetes. It allows you to add your diabetes values quickly and easily to keep track of blood sugar, carbohydrates and insulin. You can see all your recent results presented in simple graphs and decide what to do next, such as do a test, exercise, eat or take insulin.

Accessing information

Learning about diabetes can make a huge difference to how well you manage your condition. Mapmydiabetes, endorsed by the National Institute for Health and Care Excellence, is an online programme of information, guidance and self-help tools to support people in the management of their type 2 diabetes. The app is free on prescription from your GP.

"Diabetes UK's Learning Zone is a great online tool for people living with all types of diabetes to learn more about their condition and how they can self-manage it," says Howarth.

What are the downsides of using diabetes apps?

Apps can be really helpful, but it's important to remember the pitfalls. Some applications may only be compatible with US blood sugar measurement units, so make sure you check that the app gets the units right for you (mmol/L for UK).

Mobile apps are also constantly evolving, with new software updates being rolled out on a regular basis. These updates can improve user experience, but they can also introduce bugs too.

Some apps allow people with diabetes to meet others for peer support, which can be great for boosting mental well-being. However, it can be easy for misinformation to circulate because of limited moderation in online communities. It's also important to make sure your app comes from a reputable source, too.

"There are hundreds of diabetes-related apps, and it can sometimes be overwhelming to know which one to choose," says Howarth. "The NHS Apps library is also a good place to start, and your clinician can help you find the right diabetes app for you."

For those living with diabetes, the MyDiabetes app is available to download on iOS or Android to help you track and manage your condition and treatment.

https://patient.info/news-and-features/can-apps-really-help-with-diabetes-management