RESUMO
OBJECTIVE: This study aimed to evaluate the effectiveness of the Vivovitals diabetes platform in improving glycemic control and reducing hemoglobin A1c (HbA1c) levels in patients with uncontrolled type 2 diabetes mellitus by providing more accessible and direct patient care under the monitoring and oversight of their physician. METHODS: This 12-week, prospective, pragmatic, single-center, double-arm study assessed the impact of the Vivovitals diabetes platform on glycemic control in 78 adults aged ≥18 years with HbA1c levels of ≥7.5% (58 mmol/mol) at baseline. The participants were randomized into 2 groups. The control group received usual clinical care, whereas the intervention group was provided with a smartphone-linked telehealth application, a preconfigured glucometer, and access to a glycemic reading diary. The blood glucose levels of the intervention group were transmitted to the providers daily. Patients whose blood glucose level was <70 mg/dL or >180mg/dL were contacted, and modifications were made to their diet and medication. The 2 groups were compared at the baseline and at 12 weeks using nonparametric tests, with P <.05 considered statistically significant. RESULTS: Over 12 weeks, the average HbA1c level in the control group reduced by 0.474% (P = .533; 95% CI, -0.425 to -0.523), whereas the average HbA1c level in the intervention group reduced by 1.70% (P = .002; 95% CI, -1.02 to -2.39). The estimated treatment difference was expressed using Cohen d, which yielded 0.62. After 12 weeks, the HbA1c values between the control and intervention groups were statistically significant (P = .001). CONCLUSION: The use of the Vivovitals platform may help to improve glycemic control among individuals with type 2 diabetes mellitus.