Abstract
The increasing prevalence of metabolic syndrome and type 2 diabetes places a burden on healthcare systems, necessitating cost-effective, engaging and accessible interventions to address the underlying behavioral and lifestyle drivers. Our study evaluated combining Bluetooth connected OneTouch blood glucose meters (BGM) and the OneTouch Reveal mobile app with one of four digital therapeutic apps. Each group was independent, with people with type 2 diabetes (PwT2D) themselves choosing their therapeutic intervention, to better reflect real-world use. Our 3-month decentralized study screened 912 subjects, with 612 returning mail-in A1cs, providing 191 subjects (Noom = 68, Fitbit = 31, Cecelia Health = 47, Welldoc = 45) who met all inclusion criteria, including entry A1c 7.5 to 12.0%. The primary endpoint of A1c change showed improvement in the overall group by - 0.77% (95% CI - 0.98 to - 0.56, n = 141) after 3-months, Noom - 1.03% (CI - 1.4 to - 0.61, n = 49), Fitbit - 0.56% (CI - 1.0 to - 0.11, n = 24), Cecelia Health - 0.76% (CI - 1.2 to - 0.36, n = 36), Welldoc - 0.55% (CI - 0.94 to - 0.17, n = 32). In terms of secondary endpoints, more than half (56%) of these PwT2D lowered A1c by ≥ 0.5% and more than a third (36%) lowered A1c by ≥ 1.0%, with similar improvements across each of the four independent groups. Our real-world approach shows the potential for connected BGMs and widely accessible digital therapeutics to contribute to improvements in glycemic outcomes.