Diabetes App Wild West: EASD/ADA Group Hopes to Spur Change

Marlene Busko

October 10, 2019

BARCELONA — The many available apps to help diabetes patients track things like nutrition, physical activity, and glucose levels are currently unregulated in the United States, so it is hard for patients and clinicians to know which ones are best to use and recommend.

This conundrum is addressed in a joint statement, which includes recommendations, from the European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) Diabetes Technology Working Group, soon to be published in Diabetes Care and Diabetologia.

Authors G. Alexander Fleming, MD, founder and executive chairman of Kinexum, Harper's Ferry, West Virginia, and Anne L. Peters, MD, director, University of Southern California (USC) Clinical Diabetes Program and professor of clinical medicine, Keck School of Medicine at USC, Los Angeles, discussed some issues from the statement during an oral session at the EASD 2019 Annual Meeting.

They stressed that diabetes apps can help improve patient care and clinicians need to embrace new technology, but they also caution that "buyer beware" applies because these apps are not regulated.

Moreover, the US Food and Drug Administration "will not regulate most diabetes apps," Fleming told Medscape Medical News in an email, because they are not medical devices for treatment or diagnostic purposes — unlike, say, an app that gives "specific instructions for making insulin dose adjustments."

So "for the vast majority of [diabetes] apps," he noted, "it is caveat emptor."

Diabetes Apps Should Be Embraced, but Guidance Required

But at the same time, "digital apps really are valuable tools for people with diabetes [that] have enormous potential for improving clinical outcomes and reducing healthcare costs," he emphasized.

According to Fleming, these simple diabetes apps "should be embraced by all stakeholders, including healthcare providers [and among them] older people like me who may be resistant to newfangled technology."

The statement authors "hope that trusted authorities will emerge to make it easier for patients and healthcare providers to be informed" about which apps provide credible information and keep patient data secure. 

Similarly, Peters said that the upcoming statement will stress "the need for more systematic and structured guidelines for digital health app development and assessment."

From a clinician's perspective, this is "not to limit innovation but to help me figure out how to help my patients use these tools wisely."

Peters, who is a columnist for Medscape Diabetes & Endocrinology, told Medscape Medical News in an interview: "If we're encouraging patients to use apps — given that all these apps exist — what we need to have is almost like a clearinghouse to determine which ones are accurate and [keep patient's data] safe."

"I just want to know what the top four are," she said, noting that what is needed is something like the UK National Health Service (NHS) website that includes a list of 13 diabetes apps that meet their criteria.

Apps for Tracking Diet, Exercise, Not Linked to Devices

As reported in 2015, the ADA/EASD working group published a statement that outlined limitations of regulatory measures to ensure the safety of insulin pumps, and in 2017 they published a statement about continuous glucose monitoring systems.

"What we did" for the current statement, Peters said, "was look at the [existing] landscape in terms of available diabetes digital health technology, look at the practices of regulatory authorities and organizations, and then go to the next steps that we believe should be taken."

The statement focuses on the basic diabetes apps "that are easy to find, easy to get, [and] you can download them on anybody's smartphone and start using them."

"But even with these simple data-displaying apps you have to ask the question, 'Who, for instance, gets to set the target levels?'" she asked rhetorically.

And from a clinical perspective, Peters said, "I want to understand what the apps my patients are using are teaching my patients and how I can use these tools effectively to improve outcomes."

"I'd love it to be simple and easy but I'm not entirely sure that diabetes is simple or easy," she said.

It's also "hard to judge apps the way we judge a pharmaceutical pill, because apps...evolve over time...which we want...so we have to study these as they evolve and see what the benefit is for patients," Peters added.

Different Apps Suit Different Patients — Learn From Them

Another "really important point" is that not all diabetes patients are the same, so different apps suit different patients, Peters emphasized.

"I'm interested in what patients find useful," she said, "and so if a patient comes in and says 'I'm using app X, Y, or Z,' I actually do my best to try and figure out if that is in fact a well-designed app," with, for example, credible advisors.

"Then I learn from my patients what are useful apps," she continued, "and then I recommend them to other [similar] patients."

Nevertheless, "To be an informed consumer," she stressed, "you need to have some analysis of quality" of the scientific evidence and security of the patient's data.

As previously reported by Medscape Medical News, diabetes educators who are members of the American Association of Diabetes Educators (AADE) can access the Diabetes Advanced Access Network (DANA) and danatech.org, which includes  reviews of nearly 300 healthcare apps.

If "something like that...was available to all of us," Peters said, "I think would be great, but I'm sort of talking in utopian terms."

The Diabetes Wise website is also helpful for choosing devices, she noted.

And the Diabetes Forecast print and online magazine for patients published by the ADA provides an annual review about "all the devices, what's new, what pumps are good," she noted, adding that "it would be great if on a biannual basis or something they created a list of what apps seem to be the most relevant and helpful."

Call for More Evidence

The position statement ends with recommendations for regulatory agencies, manufacturing companies, professional organizations, research funders, researchers/academics, healthcare providers, and consumers.

"We...recognize the large challenges in this area of acquiring evidence to support the effectiveness and safety of these products," Fleming summarized, "but we do encourage the efforts be made to provide creditable and useful evidence."  

EASD 2019 Annual Meeting. Presented September 18, 2019.

Fleming and Peters have reported no relevant financial relationships.

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