With Howard Look, Reza Yavari, MD, and Bryan Gibson, DPT, PhD
FDA Makes Medical Device InnovationTop Priority
The Food and Drug Administration is actively committed to supporting innovations in medical devices to establish the US as the worldwide leader by the end of 2020.1 The goal is to have “more than half of manufacturers of novel technologies for the US market intend to bring their devices [here] first or in parallel with other major markets,1 according to the FDA 2018-2020 strategy document. This is likely a response to current patterns in which manufacturers make Europe their first stop in gaining approval for new devices. To fulfill this plan, the FDA has identified three priorities for the device unit:
Howard Look, founder and chief executive of Tidepool—an open source, non-profit HIPPA-compliant software company, who mission is to make diabetes data from a host of devices more accessible, actionable, and meaningful to clinicians—has raised concerns that the diabetes industry is not keeping up with the evolving regulatory environment.3
As he sees it, “the Food and Drug Administration is revolutionizing the process by which digital health products reach the public quickly, while maintaining safety and efficacy. In fact, these FDA changes have leapfrogged over much of the diabetes industry.” Tidepool is one of 9 diabetes companies participating in the FDA pre-certification program.
To catch up, Mr. Look proposed to EndocrineWeb five ways that may help diabetes product developers bring digital solutions to market more quickly:
If this has piqued your interest, you might want to join the FDA Workshop on Digital Health Innovation, as a webcast, on January 30-31, 2018. Aiming to expand upon its Digital Health Innovation Action Plan, participants in the pilot precertification program will share their experiences, accomplishments, and lessons learned, while the FDA will seek input on real-world evidence to inform advances in the development of software. For more information and to register: Device Webcast
Fitscript of New Haven, Connecticut, launched GlucoseZone™, the first digital exercise app for people living with type 2 diabetes.4 This patented app enables clinicians to prescribe tailored physical activity plans aimed to improve patients’ hemoglobin (Hb) A1c, improve weight control, and slow disease progression; and, offers patients exercise guidance based on their real-time glucose levels and other diabetes metrics, gathered from their wearable devices.4
The GlucoseZone app contains the following components: live interactive workouts, on demand workouts, and diabetes motivational lectures. In addition, the app enables users to enter and track their personal diabetes metrics so they are able to capture trends to help tailor their exercise, share the data with their clinician, and interact with digital coaches in real time.
"This app is the only software I am aware of that addresses the exercise requirement based on end-users' real-time glucose levels," said Reza Yavari, MD, an endocrinologist at Beyond Care, a metabolic rehab clinic, and adjunct faculty at Yale School of Medicine who participated in a clinical pilot. This app provides users with fitness instructions developed by diabetes experts, designed to match their individual needs, addressing a much-needed diabetes management solution that introduces a modicum of clinical supervision that has not existed for people with diabetes, according to Dr. Yavari.
GlucoseZone NOW, a 90-day digital health program at the Fitscript Diabetes Training and Technology Center in New Haven, Connecticut, has been clinically validated in a pilot study led by a team of researchers at Yale-New Haven Systems in Connecticut.4
"The personal algorithms were developed by learning from people who had diabetes but were unable to exercise because of uncontrolled blood sugar levels," Dr. Yavari.who described his clinical experience working with patients who expressed frustration and anxiety about exercising.
This trial of 12 patients, all of whom had a Hb A1c greater than 7.5 and were deemed candidates for pharmaceutical escalation, agreed to participate in the GlucoseZone program to avoid additional medication and to test the efficacy of the programming,4 Stacey Lane, manager of Living Well Cares Program, and coordinator of the pilot study told Practical Pain Management. These results were presented at the 41st annual National Wellness Conference in St. Paul, Minnesota in June 2016.
The results supported efficacy among participants who had a lower Hb A1c (average 2.0% reduction) and greater weight loss (average 9.7 lbs), as well as a slower progression of disease and, in many cases, reduced medication needs with the support of this app.4
"This app offers people with diabetes-specific guidance that will help them prevent, manage, or even reverse (in cases of type 2 diabetes) their disease," said Dr. Yavari, "and I have found it to be a useful tool to recommend to patients who are having trouble meeting their activity requirement, so they may gain the therapeutic benefits of exercise such as weight loss and cardiac risk reduction with managing their glucose levels in real time."
The company reported that trial by more than 900,000 patients, equally split between women and men, from around the world (40% in the US; 23% in India) who have benefitted from both live and on-demand interactive workouts, exercise suggestions, and diabetes-focused discussions. Information on these users is limited since they made use of the programming for free via Youtube.
Tapping into the emotional component of behavior change, a research team designed an app aimed to motivate individuals to increase their physical activity to better manage their chronic disease(s). Type 2 diabetes is complicated as these patients are usually obesity and commonly suffer from knee pain, limiting physical activity, which sets up a cycle worsening their health.
This within-subject study had 2019 adults with a type 2 diabetes diagnosis who were directed to log in to a specified website to complete seven tasks, including provide consent and personal demographics, gain understanding of the diurnal glucose curve, indicate an expected personal result, complete an interactive simulation, revisit their expected outcome, and respond to prompts about their intentions and impressions of their website experience.4
Of the 1335 who carried out the study directive, participated were primarily late middle-aged (mean 59.8 + 10.5), 57% were female, 77% were Caucasian, and 64% were deemed lower income.4 Participants intentions to walk in the coming week was achieved.4 However, a subanalysis taking into account post-study feedback reflected sufficient difficulty in navigating the website to warrant adjustments are needed to improve the efficacy of this simulation, according to the authors.
"We found the opposite of what we might have expected," said lead author Bryan Gibson, DPT, PhD, research assistant professor at the University of Utah in Salt Lake City, "
"Clearly, demographics impacted the findings," said .lead study author, "It seems that people overestimated in guessing their expected curve, and became less positive about what their results would be. We attribute this pattern to an unfamiliarity with the glucose curve based on their actual A1C level,"
"The advantage of this study is that we can say that across a large population of primarily lower-income people, we are able to change the way they think. The next step is to demonstrate that we are able to change the way they act by appealing to their belief that they are able to make choices that will improve their A1C," Dr. Gibson told EndocrineWeb.
Food and Drug Administration. Healthy innovation, safer families: FDA’s 2018 Strategic Policy Roadmap. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm591993.htm. Accessed January 16, 2018.
Tidepool. Our blog. Available at: www.tidepool.org/blog. Accessed January 16, 2018.
According to the manufacturer. GlucoseZone pilot study unpublished results. Available at: http://glucosezone.com/proven-results/. Accessed January 17, 2018.
Gibson B, Yingling L, Bednarchuk A, et al. An Interactive Simulation to Change Outcome Expectancies and Intentions in Adults With Type 2 Diabetes: Within-Subjects Experiment. JMIR Diabetes. 2018;3(1):e2.