- A new report says most mHealth apps for diabetes care management haven’t been proven clinically effective – and that consumers are “experimenting on themselves” when they use these digital health tools.
Funded by the Agency on Healthcare Research and Quality (AHRQ), the study analyzed hundreds of commercially available mHealth apps for diabetes care and found only 11 that were supported by research. And of those 11 apps, only five had been proven to help people lower their HbA1c levels.
“Although consumers have access to dozens of apps for diabetes management, only a handful of these technologies have been evaluated,” AHRQ Director Gopal Khanna, MBA, said in a press release accompanying the study, published this week in the Journal of General Internal Medicine. “AHRQ’s report helps identify an important area where more research will help us understand how these apps can improve the health of people with diabetes.”
The 73-page report, prepared for the AHRQ by the Portland, Ore.-based Scientific Research Center, part of the Portland VA Research Foundation at the VA Health Care System, continues a long-standing conundrum in mHealth circles: Consumers are clamoring for mHealth tools to improve their care management outside the doctor’s office, but many of those tools are being pushed onto the market without research that proves or disproves their benefits. As a result, clinicians are wary of embracing mHealth, preventing those digital health tools that have been proven from gaining strength for sustainability.
For the more than 30 million Americans with type 1 or 2 diabetes, the consequences of using a mobile health app that doesn’t do what it promises or offers incorrect guidance could include serious health issues, even death.
“Although there is limited evidence that commercially available mobile apps improve diabetes-related outcomes, patients are downloading and using them anyway,” the report notes. “Strong evidence can help people make informed choices, but when evidence is limited, patients who use these apps are essentially experimenting on themselves.”
“Considering this, clinicians should consider asking their patients if they use apps in their self-management, and determine if the information provided by these apps adheres to current guidance for diabetes self-management,” researchers concluded. “Patients should be aware that there is little evidence supporting the effectiveness of these apps, and should be wary of claims that these apps will improve their outcomes if not supported by evidence.”
The study focused on 280 mHealth apps now available to those with diabetes, and examined how they promised to reduce HBA1c levels, stabilize and control blood sugar levels, reduce triglyceride levels and improve the user’s quality of life.
But researchers found only 15 research articles evaluating 11 apps, six for patients with type 1 diabetes and five for those with type 2 diabetes. The found that eight apps, when paired with support from a healthcare provider or study staff, improved at least one outcome, but of those eight apps, only two were scored “acceptable” in quality testing, while there were rated as “marginal” and the other three were rated “not acceptable.”
“Our results highlight that relatively few apps available through app stores have evidence of efficacy,” they reported.
The report calls for more research to vet these apps before they become available.
“Because diabetes patients rely on these apps to manage their health, and so many apps have not yet been studied, there is a compelling need for improvement,” Khanna continued in the press release. “Not only is this report beneficial for diabetes patients, but it’s a call-to-action to the research community that we need more evidence on whether these apps and others actually improve health."
To improve the mHealth climate, researchers called on the scientific community to take five steps:
- Conduct longer studies – more than a year – on mHealth apps.
“Diabetes is a chronic condition and the risk of serious complications increases over time,” the report noted. “These complications can take several months to years to develop, and are some of the most important outcomes for studies to address. Therefore, longer-term studies are necessary to tell whether an app has an impact on the development of these complications. In addition, longer-term studies are important in determining whether patients continue to engage with these apps, or if they eventually lose interest. Longer-term studies could also help determine if the beneficial effects of apps on short-term outcomes hold up over time.”
- Include, in these studies, any adverse effects, such as hypoglycemic episodes.
- Carefully monitor interactions with study personnel and providers, so that the study focuses on the effect of the app and isn’t influenced by additional support.
- Target the most popular apps available in app stores, and make research available to consumers and clinicians.
“Patients and physicians need evidence on the apps that are currently available to them if they are to make informed decisions on which app to use in care,” the report said.
- Create a registry that tracks apps’ privacy policies and interactions with the medical record.
“The apps are only valuable if people can use them,” Stephanie Chang, MD, director of the AHRQ’s Evidence-based Practice Center Program, said in the press release. “Because apps like these are becoming part of everyday life, people should also be aware of who might eventually see their health care data and how it will be used.”