With numerous diabetes apps and virtual coaching packages in development, results are starting to emerge from studies in large numbers of patients to indicate how some of these platforms help manage disease.
Use of such digital platforms has led to dramatic drops in HbA1c, often to a level below the cutoff for diabetes diagnosis (6.5%), accompanied by significant weight loss and freedom from medications in some cases.
One is such platform is from Virta Health, an online specialty clinic, which is centered on a very low-carbohydrate diet (inducing nutritional ketosis); top-line trial data reported at the ADA 2017 meeting show that in just over 100 patients, there was a mean drop in HbA1c of -1.3% at 1 year, with 97% of patients eliminating insulin and a 14% weight loss from baseline. The 10-week results of the study were published earlier this year (JMIR Diabetes. 2017; 2:Jan-Jun), and the full 1-year results are slated for publication soon./p >
Meanwhile, trial results in over 250 patients using the One Drop mobile app have just been published and show an average drop in HbA1c of 1.36% when the app is used with an iPhone or Apple Watch over a median of 4 months (JMIR mHealth and uHealth. 2017;5:November).
Other similar coaching programs that have reported outcomes include the Livongo Diabetes Program, which offers patients a cellular-enabled, two-way messaging device that measures blood glucose, free unlimited blood glucose test strips; and access to certified diabetes educators for real-time support and goal setting. In a study comparing Livongo users (n = 646) with Livongo nonusers (n = 3014), also reported at the ADA meeting in June, there was a 1.2% decrease in HbA1c, plus significant reductions in cholesterol and triglycerides over a year, and a cost saving of $136 per month.
And in a retrospective observational study in over 440 high-risk type 1 diabetes patients consistently logging their data into the mySugr app over a period of 6 months, there was a significant drop in HbA1c of 1.3%, from a mean of 9% to 7.7%, as reported in a poster at the International Conference on Advanced Technologies & Treatments for Diabetes in February. mySugr now has over one million registered users.
Medscape Medical News sought the views of some experts on these latest developments, particularly regarding the Virta and One Drop data, which have now been formally published.
David Ahn, MD, from University of California, Los Angeles Medical Center, editor in chief of the digital health blog TechCOYD, pointed out that in a climate where medications are overused and costly, the focus on lifestyle intervention with these coaching platforms is to be applauded: "Much of their success lies in their adept use of technology to create a support network with peers and providers, and the world needs more tools like this to enable lifestyle change."
"These results are very impressive," added Gladys Block, PhD, professor emerita at Berkeley School of Public Health, California, and codeveloper of another digital platform, Alive-PD, for diabetes prevention.
Virta: Impressive Effects With Ketogenic Diet, but Can It Be Sustained?
The 262 patients with type 2 diabetes in the Virta Health trial, which is planned to be of 2 years in duration, provide daily recordings on a phone, tablet, or desktop computer including body weight and capillary blood glucose. The patients receive personalized nutrition and behavioral recommendations via continuous remote care by a health coach, medication management by a physician, biometric feedback, and peer support.
At the time of the interim 1-year analysis, 130 of 158 subjects remained actively enrolled past the 1-year time point (82% retention), and data were available for 111 patients who had completed 1-year testing. As well as mean HbA1c dropping to 6.1% (from a baseline of 7.4%), 58% of patients achieved HbA1c < 6.5% at 1 year while taking no diabetes medications or metformin only.
"These initial data demonstrate that adults with type 2 diabetes can be supported by a remote care team to maintain adequate carbohydrate restriction and achieve significant reductions in HbA1c, weight, and medications. Ongoing work will assess 2-year safety, efficacy, and sustainability," the authors, led by Sarah Hallberg of Virta Health, concluded.
Explaining some of the science underpinning the findings, Stephen Phinney, MD, chief medical officer of Virta Health, postulated that weight loss may not be the driver of improved glycemic control, but rather weight loss was a positive side effect that is achieved concurrently with a well-formulated, very low-carbohydrate diet.
Dr Block concurred. "I welcome their assertion that weight loss may accompany glycemic improvements, not necessarily cause glycemic improvements."
The keto diet, as it is known, is married to a support system that enables people to maintain this state for up to a year, according to the trial data. But Dr Phinney stressed that the level of ketone production is only one-tenth the level of the ketoacidosis seen in type 1 diabetes.
However, Dr Ahn says he believes the keto diet is extremely difficult to maintain over an extended period of time and that many people will find it to be overly restrictive.
"I'm concerned about both the generalizability and sustainability of their [Virta Health's] approach to the entire diabetes population. I also take issue with their claims of 'reversing' diabetes and having 'a life free of diabetes' in their marketingmaterial."
Dr Phinney defended use of the term "reversal," saying the program turned back glucose control but also oxidative stress and inflammation, which are linked with longevity. "If we improve biomarkers of oxidative stress then we are moving away from chronic damage." Regarding maintenance of the keto diet, he said when people experience the benefits of eliminating medications and feeling so much better, that motivates them to continue with the diet.
One Drop: Almost All Users Saw Significant Benefits, but Some Limitations
Meanwhile, the newly published One Drop trial involved 65 patients with type 1 diabetes and 191 with type 2. Patients tracked a mean of 2176 self-care activities between HbA1c entries. HbA1c fell from 8.72% to 7.36% between measurements at 60 and 365 days (median, 4 months; P < .001).
People who want to use One Drop (outside of the trial) have the option to sign up to a subscription plan that includes a Bluetooth blood glucose monitor, home delivery of blood glucose testing supplies, and 24/7 live in-app support from diabetes experts. After processing, the data are displayed on the device and insights such as prompts to take a medication, for example, aim to keep people on track.
Again, echoing the Virta Health results, One Drop reported that tracking carbohydrates was independently associated with greater improvement in HbA1c (P < .01).
Lead author on the One Drop paper, Chandra Osborn, PhD, MPH, a company employee, told Medscape Medical News that in the trial "in almost all instances, users on every configuration of our platform, across diabetes type and duration, on insulin or not, saw significant health benefit. HbA1c improves."
Dr Ahn said he appreciates the company's efforts to use coaching and a well-designed meter/app to empower their users to engage with and manage their diabetes.
But he pointed out: "It's important to note that this small study relied largely on self-reported data [and] was not randomized and did not include a control group."
A New Era for Diabetes Management: Different Costs, Levels of Support
Fundamentally, Virta Health differs from apps like One Drop at the level of real person-to-person interaction. Users of Virta Health have a personal health coach available 7 days a week, whom they can communicate with on the phone, text, or Skype.
"During the first 10 weeks there was a mean of 3.1 interactions per day," reported Virta Health's Dr Phinney. Dr Block said she believes part of the success of Virta's program can be attributed to the frequency of human interaction.
One Drop and similar products center on self-management, with digital interaction via texts or notifications, all nonverbal. This means there are very few barriers to getting people up and running with an uncomplicated app, say the manufacturers. "All you need is a smartphone," Dr Osborn noted.
"It is also highly scalable, being available in multiple languages and used around the world by many people with diabetes, not just the sliver willing to do a 20-g carb diet," she added.
One Drop is also a fraction of the price of Virta Health with subscriptions from $19.95 to $44.99 per month, with use of the mobile app free. Virta Health costs $1200 per month.
A coauthor on the One Drop paper and director of the University of Arizona Center for Border Health at the University of Arizona Health Sciences, David G Marrero, PhD, said that people who like digital technologies tend to do better with apps, as do people who tend to benefit from feedback about their personal state and progress in obtaining self-management goals.
"Some people like the stats, while others respond more to motivational messages."
He added that a key benefit of programs such as One Drop are that they "enable people to look at data in ways they haven't done habitually. This can help someone see patterns that they either didn't see before or were not attending to."
Diabetes Coaching Apps/Platforms Show Encouraging Falls in HbA1c - Medscape - Dec 14, 2017.