We described how we developed Tidepool-TIDE, a nationally available, clinical decision-support platform that reproduces the functionality of TIDE, a platform for population-level precision digital health that has been associated with significant equitable improvements to glucose management in youth with type 1 diabetes. Tidepool-TIDE is a health system agnostic platform designed and engineered to reduce common barriers to scaling technology from one site to many. Patient management is supported by a fully interpretable population-level approach to triaging patients and identifying specific opportunities for improved glucose management. No institutional data science, engineering, nor IT professionals are required to set up data pipelines nor to deploy and maintain the platform. Tidepool-TIDE supports core clinical and administrative workflows on a single platform and has the capability to integrate with EMRs, eliminating the need for additional tools and processes to incorporate the RPM-CDS platform into care delivery. Tidepool-TIDE is now available as a turnkey upgrade for over 1000 clinics using Tidepool.

Leveraging technology-enabled care can create opportunities to decrease unnecessary healthcare utilization (e.g., fewer clinical visits for patients with well-managed diabetes) and increase equitable healthcare access (e.g., patients’ condition can be remotely monitored and managed regardless of geographical location or other factors that may pose challenges to clinical visits). A key principle of the 4T study has been equitable access for all newly diagnosed youth with T1D. Data from the 4T Pilot study demonstrated similar improvement in HbA1c at 1-year after diagnosis independent of insurance or language status¹². The technology-enabled care model may serve as an example for equitable, effective, and efficient management of other health conditions such as heart disease and asthma, where remote patient monitoring has been beneficial³⁷. For example, a Tidepool-TIDE-like platform connected to wearable devices and sensors measuring vitals, physical activity, and inhaler usage may help clinicians identify and care for patients at risk of deteriorating cardiovascular or respiratory functions at population scale³⁸.

The increased adoption of CDS for RPM has come with increased concerns about its efficacy and cost effectiveness. While randomized controlled trials are the gold standard for evaluating the efficacy of a new intervention, incorporating them into clinical care pose significant costs, challenges, and the ethical dilemma that a subset of patients is excluded from the potential benefits of the technology^39,40. These concerns can be minimized while ensuring internal validity through partial randomization. Outside of healthcare, it is common practice for companies to employ randomized A/B testing to compare different options, evaluate effectiveness of iterative changes, and make data-driven decisions before deploying something to the entire audience^41,42. However, health systems tend to implement interventions wholesale and rarely formally analyze the effectiveness of interventions deployed⁴³. We developed functionality to allow partial randomization as part of routine care to facilitate larger research studies across health institutions and systematically measure the impact of any changes to care delivery. Partial randomization allows Tidepool-TIDE to continue to present all patients that meet criteria for review while introducing an aspect of randomization for inclusion of additional patients who don’t meet the criteria for review. This has the potential to facilitate rigorous evaluation of the impact of the use of Tidepool-TIDE and of any iterative changes to clinical interventions or operational design through micro-randomized control and treatment groups. Since the number of patients meeting the criteria for review may vary from review period to review period, our proposed randomization method would include additional patients only in those periods where there is sufficient capacity for them. Numerous statistical design and analysis methods are now available to leverage the partial randomization functionality enabled by platforms such as Tidepool-TIDE^34,35,44. The combination of the partial randomization functionality of Tidepool-TIDE together with appropriate statistical design and analysis has the potential to enable a virtuous feedback cycle for continuous improvement. The use of partial randomization as part of routine care made possible in Tidepool-TIDE will require additional study and site-specific considerations to ensure patient safety and valid experimental design.

Tidepool-TIDE is now in use at Stanford Children’s Health to support patient care for the 4T study in a pilot phase, facilitating continuous evaluation and improvement through survey feedback from the clinical team and proxies to time-per-patient-review. Following the pilot phase, the goal is to transition this research care model into Stanford Children’s standard of care so that all pediatric T1D patients are reviewed through Tidepool-TIDE. Data collection for a formal evaluation of the ease-of-use and clinical efficacy of Tidepool-TIDE compared to TIDE is ongoing.

A component of the transition to Tidepool-TIDE has been to collaborate with the hospital’s billing and compliance teams to create financially supported and sustainable RPM workflows. While RPM evaluation and management codes were included in the 2018 Centers for Medicare and Medicaid Services fee schedule, payment for these RPM codes vary state-by-state^37,45. Some codes are also focused on adult populations, limiting pediatric usage of RPM codes⁴⁵. For self-sustaining and equitable RPM implementation at scale, consistent health plan reimbursement, especially for public plans like Medicaid is critical¹⁵. This is an ongoing topic of investigation.

Beyond Stanford, we are collaborating with other diabetes centers in the US to develop research studies to disseminate and implement the 4T care model powered by Tidepool-TIDE. Access to the Tidepool-TIDE platform will provide opportunities for other clinics and investigators to innovate on how to apply RPM to improve care delivery and outcomes in their healthcare systems. This can be particularly impactful as sample size has thus far been a main limitation of pediatric telemedicine studies². Future work should adopt successful methodologies and guiding principles from the study of innovation. For example, classifying diabetes centers by their attitudes to the adoption of new technology may facilitate identifying promising partners to scale the use of Tidepool-TIDE⁴⁶.

We prioritized addressing user needs that were fundamental for effective and efficient technology-enabled care, differentiating them from health institution-specific or study-specific needs that may be an artifact of having initially launched the program at Stanford. These features were implemented in the initial version of Tidepool-TIDE while others were scoped for a future iteration. Future iterations of Tidepool-TIDE can incorporate data from more wearable devices for a richer view into patient conditions and explore artificial intelligence (AI)-based approaches that can provide more sophisticated insights for care management than a rules-based approach. Data from additional sources such as activity monitors can enhance existing algorithms, accounting for how other comorbidities may influence T1D management and outcomes⁴⁷. AI-generated recommendations can also be incorporated into provider-patient messaging to improve patient education and promote patient engagement. Although Tidepool-TIDE is exclusively designed for diabetes care management, our approach may offer lessons for institutions interested in making their locally developed digital tools for various chronic health conditions more broadly accessible.

The primary limitation of this work is that data are not yet available on the user experience nor patient outcomes associated with the transition from TIDE to Tidepool-TIDE at Stanford, from deployments of Tidepool-TIDE at other institutions, or to other platforms. However, as most patients and clinics are not cared for with a CDS platform and TIDE is an integral part of the 4T study which showed a 1.1% decrease in A1c, we are optimistic that the useability and outcomes associated with the use of Tidepool-TIDE, which replicates and improves on TIDE, will compare favorably to the status quo^{12,13,14,15,16,18}. As this was a large software development project, some technical details necessary for the reproducibility of the paper are missing or summarized. Since Tidepool is open-source, the entirety of the implementation and code base are available for review⁴⁸. Whether the Tidepool-TIDE platform may improve outcomes independent of the overall 4T diabetes care management approach has not been tested. Unlike insulin dosing CDS tools, Tidepool-TIDE currently does not formulate and communicate recommendations directly with patients or caregivers¹². Rather, it automates data analysis at population-scale so that clinicians can prioritize their attention on patients with deteriorating diabetes conditions and perform timely clinical interventions orthogonal to in-person visits. Similar decision support features could be implemented within the Tidepool-TIDE model in the future.

RPM-CDS platforms like Tidepool-TIDE depend on access to electronic health information (EHI). Prior to the 21st Century Cures Act, information blocking was a prevalent issue in healthcare innovation as EHR vendors and health systems partook in practice “likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information”^49,50,51. While the passage of the Cures Act mandating healthcare organizations to share EHI and meet standards of interoperability is promising, the Cures Act does not impose the same requirements on medical device manufacturers, which can pose challenges to access of data collected through wearable devices^51,52. Data access is subject to the individual cooperativity of device manufacturers, their internal prioritization of the feature against other roadmap features that could be more directly tied to revenue generation, and the speed with which they are able to support data sharing for devices already released on the market. Patients and clinicians may go months or years without having access to their diabetes EHI. Public policy that includes device manufacturers in the standards of interoperability and data sharing may increase data access to facilitate better care and health delivery innovation.

Using design principles, workflow analysis, and software development, an interdisciplinary team from Stanford and Tidepool developed Tidepool-TIDE, a clinic-agnostic, nationally-available tool for personalized diabetes care at population scale. Tidepool-TIDE reproduces and improves the core functionality of the original tool that, when used as part of the 4T Study, was associated with significant, equitable reductions in patient HbA1c and reductions in care provider screen time. Tidepool-TIDE is now available as a turnkey option for over 1000 US clinics using Tidepool.