- Of the hundreds of diabetes self-management apps currently in the market, just 11 have been subjected to clinical studies — none of which were particularly rigorous, according to a recent technical brief by the Agency for Healthcare Research and Quality.
- And of those 11 apps, just five were associated with meaningful improvements in HbA1c.
- Not a single study demonstrated improvements in quality of life, blood pressure, weight or body mass index, the agency says.
For all the hype about digital health apps, providers still need solid data and evidence to back up treatment. And if this review is reflective of medical apps more generally, that’s not happening to the degree it should be.
According to AHRQ, all of the studies had methodological shortcomings, from brevity (two to 12 months) to inconsistent reporting and use of co-interventions that made it difficult to understand the results.
“Our results highlight that relatively few apps available through app stores have evidence of efficacy, which is consistent with findings of other systemic reviews,” the brief says. “For example, we did not find evidence for many of the apps that appear first when searching Google and Apple app stores, such as Diabetes: M, Diabetic Diet, MySugr, Blood Glucose Tracker, Sugar Sense, Diabetes and Blood Glucose Tracker, Carb Manager, or Diabetes In Check.”
To improve the quality of future studies, AHRQ recommends they be longer than one year. Diabetes is a chronic disease, and the risk of serious complications grows over time, the paper says. Studies should also report the app version, timing of any updates and notable changes to features or content as well as include complications such as hypoglycemic episodes,
In addition, randomized trials should control for interactions between patients and providers, and there should be wider dissemination of research results, AHRQ says.
Diabetes management has been a popular area for mobile health developers. Last year, CNBC reported Apple had hired a team of biomedical engineers to develop noninvasive blood sugar monitors. Around the same time, Merck and Amazon Web Services announced a contest for developers to create products for people recently diagnosed with Type 2 diabetes using Alexa voice-enabled technology. Proper use of such apps could save billions in health spending every year, but the lack of reliable research is a setback. The industry is discussing mobile health guidelines, including suggestions for basing content on evidence-based practices.
Providers are looking to digital apps to help with social determinants and population health, remote patient monitoring and other clinical benefits. But many are rightfully skeptical of the impact digital tools have on health outcomes. “In order for me to confidently use the product and put my own reputation on the line when recommending use to colleagues and patients, I need to have validation evidence that shows its safety and efficacy,” Alex Ding, a private practice diagnostic and interventional radiologist in the San Francisco Bay area, told Healthcare Dive in an interview last year.
Of the five apps that underwent health outcomes testing, two — Glucose Buddy and Sanofi and Voluntis’ Diabeo Telesage — are for Type 1 diabetes and three — WellDoc’s Blue Star, Chinese-made WellTang and India-based Gather Health — are for Type 2 diabetes.