Arlington, VA — May 8, 2018 — The Digital Therapeutics Alliance welcomes nine companies to membership: Bayer, Big Health, Cognoa, Kaia Health, Merck, Omada Health, Otsuka America Pharmaceutical, Inc., Pear Therapeutics, and Sanofi.
“Digital medicine has the potential to safely and effectively help millions of people suffering from chronic and mental health conditions. We are proud to hold digital therapeutics to the same standards of clinical evidence as traditional medicine,” said Peter Hames, Co-Founder, CEO of Big Health.
DTA launched in October 2017 through a collaboration of four digital therapeutics companies: Akili Interactive, Propeller Health, Voluntis, and WellDoc. “DTA is committed to convening industry leaders sharing a passion for crafting a strong future for the integration of tested, trustworthy digital solutions in healthcare,” said Pierre Leurent, CEO of Voluntis and DTA Board of Directors Chair.
“Digital therapeutics is a shining light in the crowded digital health landscape. Each DTA member has used clinical validation and evidence to provide data-driven treatment options and we look forward to working with the Alliance to advance this evidence-based approach,” says Eugene Borukhovich, Global Head, Digital Health at Bayer.
In its first year, DTA is committed to engaging with patients, providers, payers, and regulators to define and develop meaningful resources to guide and scale this quickly evolving industry.
“Patients, clinicians, and insurers are looking for effective solutions to prevent, manage, and treat chronic disease,” said Sean Duffy, CEO, Omada Health. “Digital therapeutics deliver reliable, meaningful clinical results that empower patients. This is important work.”
“We are pleased to work with the Alliance on the introduction of prescription digital therapeutics,” said Corey McCann, President and CEO of Pear Therapeutics. “DTA has a critical role ensuring digital therapeutics are clinically-validated, built according to Good Manufacturing Practices, rooted in Good Clinical Practices, and evaluated thoroughly by regulatory bodies to verify these products are safe and effective. Patients and providers deserve nothing less than the same standards of any other therapeutic.”
About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. To learn more please visit: www.dtxalliance.org.
The authors found that participants experienced several positive clinical outcomes, including a 78% reduction in rescue inhaler use and a 48% improvement in symptom-free days. The hundreds of thousands of crowdsourced real-world data points on inhaler use, combined with environmental data, also informed municipal policy recommendations, including enhancing tree canopy, tree removal mitigation, zoning for air pollution emission buffers, recommended truck routes, and development of a community asthma notification system.
WellDoc®, a leading digital health company, announced today that its clinically proven hemoglobin A1C reductions for users of its BlueStar® digital therapeutic with type 2 diabetes can translate into significant healthcare cost savings.
Propeller Health and Express Scripts (NASDAQ: ESRX) announced a strategic partnership to provide Propeller’s FDA-cleared digital solution to Express Scripts members using inhaler sensors and a mobile app to manage asthma or COPD. This collaboration is the largest respiratory digital health deployment with a pharmacy benefit manager to date.
Journal of Occupational and Environmental Medicine — August 2017 —
Objective: To evaluate a digitally delivered, intensive behavioral counseling program for a workforce at risk for obesity-related chronic disease.
Methods: Employees were offered a digital health program modeled after the diabetes prevention program (DPP). Annual workforce health assessments were used to examine changes in chronic disease risk factors between participants (n = 634) relative to a matched comparison group (n = 1268).
Results: Overall, employees were gaining an average of 3.5 pounds annually before program inception. Program engagement was positive; 83% completed the majority of the curriculum and 31% lost at least 5% of their starting weight. Compared with non-participating peers, participants demonstrated reduced weight, improved fasting blood glucose, and improved nutritional intake after a year.
Conclusions: The digital health program was effective for engaging employees in health behavior change. Digital options facilitate widespread implementation.
American Journal of Respiratory and Critical Care Medicine 2017 — May 2017 —
Rationale: Digital health interventions have demonstrated positive impacts on clinical outcomes in asthma, but data on their impact in chronic obstructive pulmonary disease (COPD), and among older populations, have been limited. We aimed to assess the feasibility and clinical impact of a digital health intervention in a Medicare population with COPD or asthma.
Methods: Participants were enrolled in a single arm, pre-post digital health pilot study at the JenCare clinic in Louisville, Kentucky. Participants were eligible with a diagnosis of asthma or COPD and a compatible short-acting beta agonist (SABA) medication. Participants recived a Bluetooth-enabled inhaler sensor, which tracked the date, time, and frequency of medication use for 12 months. Participants without a smartphone were offered a wireless hub for data transmission. Participants received access to web-based dashboards and emails that provided information about their disease status and guidelines-based education. JenCare staff monitored medication use through a web-based dashboard to inform care and identify signals of acute worsening. To assess feasibility, we evaluated the number of participants that enrolled and synced a sensor to initiate data transmission, and the duration of active participation. To assess impact on clinical outcomes, we evaluated the impact on SABA use and symptom-free days at 6 months versus baseline.
Results: 236 participants were enrolled, including 198 with COPD and 38 with asthma. Of these participants, 222 (94%) synced a sensor to begin data transmission and 192 (81%) were active after 10 months.
Among asthma participants, 65% were 60 or older and 82% were female. Participants self-identified as 39% White and 58% Black. 95% trasmitted data via wireless hub. 82% were considered uncontrolled at enrollment as measured by the ACT. After 6 months, SABA use had decreased from 1.15 (first week) to 0.56 uses/person/day (last week), a significant decrease of 51.4% (p<0.05). Symptom-free days increased from 46% to 59%, a 28% improvement.
Among COPD participants, 78% were 60 or older and 66% were female. Participants self-identified as 53% White, 44% Black, and 3% other. 97% transmitted data via wireless hub. After 6 months, SABA use decreased from 1.53 (first week) to 0.74 uses/person/day (last week), a significant reduction of 51.7% (p<0.01).
Conclusion: A digital health intervention was feasible and effective among older, diverse Medicare population. Participants demonstrated high activation and retention rates, significantly reduced SABA use and more symptom free days.
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PLUS ONE — April 2017 —
Children with Sensory Processing Dysfunction (SPD) experience incoming information in atypical, distracting ways. Qualitative challenges with attention have been reported in these children, but such difficulties have not been quantified using either behavioral or functional neuroimaging methods. Furthermore, the efficacy of evidence-based cognitive control interventions aimed at enhancing attention in this group has not been tested.
Here we present work aimed at characterizing and enhancing attentional abilities for children with SPD. A sample of 38 SPD and 25 typically developing children were tested on behavioral, neural, and parental measures of attention before and after a 4-week iPad-based at-home cognitive remediation program. At baseline, 54% of children with SPD met or exceeded criteria on a parent report measure for inattention/hyperactivity. Significant deficits involving sustained attention, selective attention and goal management were observed only in the subset of SPD children with parent-reported inattention. This subset of children also showed reduced midline frontal theta activity, an electroencephalographic measure of attention.
Following the cognitive intervention, only the SPD children with inattention/hyperactivity showed both improvements in midline frontal theta activity and on a parental report of inattention. Notably, 33% of these individuals no longer met the clinical cut-off for inattention, with the parent-reported improvements persisting for 9 months.
These findings support the benefit of a targeted attention intervention for a subset of children with SPD, while simultaneously highlighting the importance of having a multifaceted assessment for individuals with neurodevelopmental conditions to optimally personalize treatment.
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Environmental Health Perspectives — February 2017 —
Background: Epidemiological asthma research has relied upon self-reported symptoms or healthcare utilization data, and used the residential address as the primary location for exposure. These data sources can be temporally limited, spatially aggregated, subjective, and burdensome for the patient to collect.
Objectives: First, we aimed to test the feasibility of collecting rescue inhaler use data in space–time using electronic sensors. Second, we aimed to evaluate whether these data have the potential to identify environmental triggers and built environment factors associated with rescue inhaler use and to determine whether these findings would be consistent with the existing literature.
Methods: We utilized zero-truncated negative binomial models to identify triggers associated with inhaler use, and implemented three sensitivity analyses to validate our findings.
Results: Electronic sensors fitted on metered dose inhalers tracked 5,660 rescue inhaler use events in space and time for 140 participants from 13 June 2012 to 28 February 2014. We found that the inhaler sensors were feasible in passively collecting objective rescue inhaler use data. We identified several environmental triggers with a positive and significant association with inhaler use, including: AQI, PM10, weed pollen, and mold. Conversely, the spatial distribution of tree cover demonstrated a negative and significant association with inhaler use.
Conclusions: Utilizing a sensor to capture the signal of rescue inhaler use in space–time offered a passive and objective signal of asthma activity. This approach enabled detailed analyses to identify environmental triggers and built environment factors that are associated with asthma symptoms beyond the residential address. The application of these new technologies has the potential to improve our surveillance and understanding of asthma.
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Journal of Aging and Health — January 2017 —
Objective: To examine the outcomes of a Medicare population who participated in a program combining digital health with human coaching for diabetes risk reduction.
Method: People at risk for diabetes enrolled in a program combining digital health with human coaching. Participation and health outcomes were examined at 16 weeks and 6 and 12 months.
Results: A total of 501 participants enrolled; 92% completed at least nine of 16 core lessons. Participants averaged 19 of 31 possible opportunities for weekly program engagement. At 12 months, participants lost 7.5% (SD = 7.8%) of initial body weight; among participants with clinical data, glucose control improved (glycosylated hemoglobin [HbA1c] change = −0.14%, p = .001) and total cholesterol decreased (−7.08 mg/dL, p = .008). Self-reported well-being, depression, and self-care improved (p < .0001).
Discussion: This Medicare population demonstrated sustained program engagement and improved weight, health, and well-being. The findings support digital programs with human coaching for reducing chronic disease risk among older adults.
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Journal of Medical Internet Research — October 2016 —
Background: Digital health tools are increasingly recognized as effective in improving asthma clinical outcomes such as control and adherence; however, few studies have evaluated patient perspectives on the usability and value of these tools in supporting asthma self-management. Patient perceptions of digital health tools, including usability and satisfaction, will determine the success of these digital health interventions and the durability of their effects.
Objective: We aimed to assess patients’ usability feedback and satisfaction with an asthma digital health platform after 12 months of use.
Methods: We administered surveys to participants of a randomized controlled clinical study designed to measure the clinical effectiveness of the Propeller Health Asthma Platform. The electronic surveys evaluated patients’ feedback on the usability of the sensor and the perceived value of the platform and information provided after 12 months of use. The clinical study had enrolled patients (N=495) in parallel arms from specialty and primary care clinics. Intervention group patients (n=250) used electronic inhaler sensors to track the date, time and geographic location of medication use. Patients received access to a digital health platform including smartphone and Web-based applications that provided information about their asthma medication use trends, real-time asthma control, guidelines-based education, and personalized support for 12 months. Physicians could monitor the status of their patients and receive notifications about short-acting beta agonist (SABA) overuse. Survey results reported here represent adult participants from the intervention group who completed the exit survey at 12 months.
Results: Respondents (n=89) reported being very satisfied (79%) or somewhat satisfied (20%) with the inhaler sensor, stating that the sensor was “small,” “unobtrusive,” and “easy to use” and carry. A total of 90% of respondents found the information they received via the platform useful, with 93% expressing satisfaction with the information. In open-ended responses, participants cited valuing how the platform increased awareness about their asthma control status and medication use, provided “relevant” and “timely” information, and identified potential environmental triggers that exacerbated their symptoms, with 65% of respondents identifying 1-7 new triggers as result of the information. Respondents described improved communication with their doctors: 46% of the respondents had talked with their doctor about the information they received, and 22% stated that their doctor recommended or changed a specific aspect of their asthma management as a result of the information. Over 50% of respondents said that they felt their asthma was more controlled as a result of the information they received, which is supported by the clinical results demonstrating 63% of uncontrolled patients achieved control during the program.
Conclusions: Patients reported positive usability of a digital health platform for asthma self-management, citing that it was easy to use and fit into their lives unobtrusively. Almost all patients perceived value from the digital health platform in contributing to their self-management, finding value in increasing self-awareness, identifying asthma triggers, offering actionable information, and improving communication with their doctors.
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