Introduction/Rationale: Advances in diabetes remission programs have markedly improved type 2 diabetes (T2D) management, addressing glycemia, blood pressure, and microvascular health. However, the high demand for in-person medical consultations increases costs and decreases patient engagement. Recognizing these challenges, the DIGEST study by Habitual explores the efficiency of a remote-delivered diet replacement and digital therapy for T2D remission and weight loss, circumventing the traditional clinical visit model. The study employed Lindus Health for a fully virtual trial, navigating strict recruitment criteria through digital outreach and a primary care network.
Methods: Lindus Health executed a fully virtual design, enabling remote monitoring for six months. The approach utilized digital marketing and referrals from ten GP sites to attract participants, directing them to a study website for initial screening. Eligible individuals underwent a virtual assessment by Lindus Health nurses for deeper engagement and informed consent.
Results: Lindus Health's strategies enabled Habitual to reach its recruitment goal of 100 patients in five months, significantly ahead of the initial 12-month prediction. The trial's decentralization allowed for UK-wide participant inclusion, reaching over 16,000 people through online advertising. Remote monitoring facilitated home-based study participation, allowing real-time tracking of patient progress and enhancing the trial's patient-centric approach.
Conclusion: The DIGEST study demonstrates the potential of fully decentralized trials in T2D management, showcasing the Habitual Remission Program's efficacy. The model's success, driven by virtual designs and strategic recruitment, highlights a shift towards more accessible, efficient clinical research, suggesting a scalable and patient-friendly future for digital health solutions in disease management.
M. Gorobzov: None.
