DTA Responds to the Peterson Health Technology Institute’s Evaluation of Digital Diabetes Products

Digital Therapeutics Alliance appreciates the effort put forth by PHTI  to evaluate digital health technologies. DTA acknowledges the importance of evaluating evidence and health economics, as these principles are integral to our core values. Unfortunately, the framing of this report detracts from the evidence based approach that they are attempting to promote.

DTA was established with a commitment to incorporating clinical rigor into all healthcare solutions. In the digital health and mobile health sphere, numerous products fail to adhere to our industry core principles, as outlined in our documentation. However, DTA’s member companies, including DarioHealth whose product is included in this report, align with these principles, sharing common goals with PHTI, such as striving for clinically meaningful outcomes for diverse patient populations, adhering to best practices in quality, ensuring patient privacy and security, and prioritizing real-world outcomes and product performance, among others.

When organizations join our alliance we expect the utmost respect for the delivery of healthcare and the data to support cost and interventions. We were founded in an effort to bring clinically validated products to patients, and ensure that non-validated products do not hurt patients and caregivers.

PHTI’s “transparent evidence-based approach” follows the ideas and philosophy that DTA and its members embrace. While we support their overarching methodology, it’s essential to address specific oversights in the approach to evaluate the products and suggest areas for improvement in future reports. We would like to further promote transparency and inclusivity in future reports. The following is a demonstration of areas of improvement:

1. 1. The limited selection of solutions included overlooks a significant portion of the diabetes related digital health products on the market today, some of which can be found on DTA’s product library. The low sample size of this report’s study does not accurately reflect the products on the market, making its generalized conclusions somewhat misleading. How do we take a small sample size and make a sweeping conclusion for all diabetes products? We were fully expecting a framing of a spectrum of solutions that have both positive and negative healthcare implications, and there are a number of products that provide positive clinical and economic outcomes.
   2. While a predictive model makes sense when RWE doesn’t exist, we must include RWE when it’s available. The report’s reliance on predictive models rather than actual cost savings studies for health economics overlooks real-world evidence, particularly concerning products like Dario, included in the report,  for which there are independently published comparative studies demonstrating substantial healthcare cost reductions and reductions in hospitalizations.(Link to Studies) Comparative studies using actual HCRU data are generally considered more rigorous than the budget impact models using putative cost models. Comparative studies using actual HCRU data across the US are highly generalizable and scientifically rigorous. These types of comparative studies based on actual utilization reduction are preferred by health plans and other payors over predictive models. It is concerning that PHTI intentionally excluded published real-world economic studies in favor of lower performing predictive figures.
   3. PHTI’s approach to analyzing digital health technologies by disease state presented an opportunity to include scientific and economic experts specific to the condition, in this case, diabetes. We would like, again, to request further transparency, and include as many key stakeholders and clinical advisors as possible. For example, we did not see any of the 9,000 endocrinologists (diabetes experts) listed as advisors. Had there been expertise in this evaluation, they may have considered the broader scope of diabetes management like reductions in hypo- and hyperglycemic events, in addition to the reduction of A1C levels. 

DTA respectfully disagrees with the conclusions drawn, particularly in the case of DarioHealth as we can only speak to the evidence and performance of DTA member companies.

PHTI has the opportunity to support the future of healthcare by developing an advanced approach evaluation to match advancements in treatments and the new expectations of today. The expectations include positive, real-world health and economic outcomes, addressing the whole person, and accessibility to diverse patients. We recommend PHTI include experts that are specific to the condition they are studying,  invite more stakeholders to provide input into their analysis via public forums like we see with ICER and CMS, expand the cohort before making generalizations, and be more transparent on inclusion and exclusion of evaluation criteria. DTA looks forward to supporting PHTI in its future efforts to evolve the evaluation of modern medicine.