This 12-week, prospective, pragmatic, single-center, double-arm study assessed the impact of the Vivovitals diabetes platform on glycemic control among 78 adults ≥ 18 years of age, with A1C ≥ 7.5% (58 mmol/mol) at baseline. The participants were randomized into two groups. The control group received usual clinic care, while the intervention group was provided with a smartphone linked telehealth application, a pre-configured glucometer, and access

to the glycemic readings diary. Blood glucose levels of the intervention group were transmitted to the providers daily. Patients whose blood glucose levels were <70 mg/dL or >180mg/dL were contacted, and modifications were made to diet and medication. The two groups were compared at baseline and 12 weeks using nonparametric tests with p<0.05 considered statistically significant.

Over 12 weeks, the average A1C in the control group reduced by 0.474% (p=0.533; 95% CI: -0.425, -0.523) whereas the average A1C in the intervention group reduced 1.70% (p=0.002; 95% CI: -1.02, -2.39). The estimated treatment difference was expressed via Cohen’s d which yielded 0.62. After 12 weeks, A1C values between the control and intervention groups were statistically significant (p = 0.001).