Counseling Patients on CGM, Smartphone Compatibility Usage

Recently, the FDA alerted users of missed notifications for continuous glucose monitoring devices and Bluetooth smartphone compatibility. | Image Credit: Pixel-Shot | stock.adobe.com

The FDA issued an alert to patients of potential safety concerns for diabetes devices, including continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems, specifically those that rely on a smartphone to deliver safety alerts. The agency received reports in which users said the safety alerts are not being delivered or heard, even in cases where the user thought they set the alerts to be delivered. The FDA reported that some cases of missing alerts contributed to events such as severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and even death. Currently, the FDA is working with manufacturers to ensure that smartphone alerts are carefully evaluated prior to use by patients.

In the interview, Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, endocrine clinical pharmacy specialist, director of education & training in diabetes technology at the Cleveland Clinic Endocrinology & Metabolism Institute, discussed the benefits and risks of using continuous glucose monitoring (CGM) systems with smartphones. She discussed the recent alert by the FDA, alerting of potential missed notifications for Bluetooth devices. Further, Isaacs talked about preventing compatibility issues and how to counsel patients who are concerned.

Drug Topics: What are your initial thoughts on the FDA's alert about potential missed safety notifications with smartphone-compatible diabetes devices?

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP: Well, I have a lot of thoughts about this. On one hand, I'm disappointed that we need to have this FDA alert and that we don't have technology that is just perfect, and we can trust the alerts all of the time. But I am happy that the FDA put out this alert because this is a reality with our current smartphones that there can be just issues that cause an alert to not be received, and I think it's really important that patients know about that so that they really can double check their glucose They can rely more on their symptoms versus only relying on an alert from a device. So I do think the FDA certainly did the right thing by putting this alert out.

Drug Topics: What are the potential consequences of missed safety notifications for patients with diabetes?

Isaacs: It can be quite serious. I mean worst-case scenario is if a person is having an urgent low glucose and doesn't receive an alert and therefore does not take action by eating, drinking, or treating their low; I mean, they can pass out. It could lead to death in the worst-case scenario. Now, fortunately, a lot of people will feel symptoms, and they can take action, and so usually that doesn't happen, but certainly there is that risk of that happening.

Drug Topics: The FDA recommends that patients periodically check smartphone settings to ensure safety alerts are being delivered. How do you counsel patients on the best practices for checking these settings and confirming device functionality?

Isaacs: I think this is a really important point for anyone that works with patients in CGM. So generally, we discourage the automatic updates where you go to the latest operating system because it takes a little bit of time for these mobile apps to be tested and be compatible with the latest update, and so we actually train patients to toggle that off so it's not automatically updating, and that's one way to hopefully prevent that compatibility issue. The other thing I'd say is just periodically testing it. Now, most will know because they'll get a higher, they'll get a low, and they'll hear it go off. But I would say that if someone hasn't noticed an alert in a while, go ahead and check the system and make sure that it's still working, perhaps adjusting it to something they're more likely to reach with their number, and just confirming that it truly is going off; it's making a sound and everything.

Drug Topics: What are some practical tips you can share with patients to ensure they receive critical alerts from their diabetes devices?

Isaacs: I would just say making sure that it's not automatically updating, going ahead and checking like they could change your high alert to like 140 if you want, and a person should hit that anytime they eat, so that doing those types of things can just double check that it truly is working. I'd also say it's important to remember that technology is not perfect all the time. So we want to back up. We really want people to still feel the symptoms of low glucose levels and not lose sight of what those are. Then also, I'd say, having a backup meter, just in case, because the instructions for all of them are, if a person has symptoms that don't line up with what the number is saying on the CGM device, they really should confirm with a finger stick. I think just remembering that technology, it's just not perfect 100% of the time.

Drug Topics: Do you believe that the benefits of smartphone-compatible diabetes devices outweigh the risks associated with potential missed notifications?

Isaacs: No, I think 100%, the benefits are worth this risk. So I want to highlight that this is not a super common occurrence where the alerts aren't going off. I would say it's not something that happens to many people, so it is certainly not a common occurrence in terms of benefits of it being on the smartphone. There are so many, it makes it much easier to share data with the health care team. So through the Bluetooth and the data going into the cloud, we can see it. We don't have to download a device. We don't have to bring a patient into clinic. We can do a virtual visit, a phone visit. We can do remote monitoring with that data. So that makes it super useful, and then the other thing with smartphones is that all the CGMS have a follow app that you can use when it's on the smartphone versus if you're just using a separate reader or receiver, you can't use those follow apps. Then the other thing I'd say is that it's just a whole lot more convenient to carry 1 device instead of 2. So asking a person to have a separate reader or receiver and their phone, they're more likely leave it somewhere, or forget about it, or lose it, and then they're not going to get any alerts if that happens. So I think definitely the benefits outweigh the risks.

Drug Topics: How do you address patient concerns about the reliability and safety of smartphone-compatible diabetes devices?

Isaacs: Using a smartphone that's been tested with the system is important. So there are a whole lot of different versions of smartphones, especially when it comes to Androids. I think there's a lot of different types, right? And on the respective CGM websites, you can get a list of the devices that are truly compatible along with the operating system. So it's important to use one that has been tested and true and everything, and then just going into the settings, making sure the critical alerts are on and everything. If there is any concern, all of them have a number, like a customer support number to call, to double check that it's working, it's compatible, and everything. So I think in doing those things generally, we can really trust the devices.

Drug Topics: What is the role of that pharmacist in diabetes care for patients, especially with CGMs?

Isaacs: First of all, making sure patients know what the target ranges are and what all this data means, and I don't mean that the pharmacist needs to, like, go through and teach about glucose variability, and all of these like more complicated concepts. I just mean that we want a person to be able to see their number and understand, like, is this in range, or is this above, or are they having a low, and then what to do about it, and especially, I would say, treating low glucose levels, understanding that we generally consider, for most people under 70, to be a low, what to do about that, and then also setting alerts that are meaningful. Some people have the opposite problem, where they say their CGM is beeping and buzzing at them all the time, and even though they get all the alerts, they kind of ignore them because it's just alerting all the time, and so that's not good either. We want it to be meaningful alerts, and the pharmacist can have a great role in helping the person set a low that will be meaningful. For some people, that may be higher than 70, maybe that's going to be 80 or higher, and then setting a high alert that also is meaningful, or even turning it off for some people, and I think those are key things, and then also, I think it's great to go into the device turn off those automated updates for the operating system. That's a way to just prevent this kind of complication from coming up where they don't get any alerts.

Drug Topics: Is there anything else you would like to add?

Isaacs: I think CGM systems are incredible, and when you think about how far we've come from blood glucose monitoring [(BGM)] devices to this growth of CGM where tons of people have access to it, and I know it's really annoying if someone should be getting alerts and they're not getting them. But think about the days of BGM, right? People aren't getting any alerts. If they don't say, in this moment, I'm going to check my glucose, I'm going to bring out my meter and poke my finger, right? They're not going to get an alert. So these devices are lifesaving, their life changing, and I'm really happy to see that more and more pharmacists are learning about these devices and bringing them to their patients and really supporting their use so that we can give the best outcomes for people with diabetes.