Department of Endocrinology, Icahn School of Medicine at Mount Sinai, Queens Hospital Center, Queens, New York.
Department of Medicine, Icahn School of Medicine at Mount Sinai, Queens Hospital Center, Queens, New York.
Endocr Pract. 2023 Jun;29(6):441-447. doi: 10.1016/j.eprac.2023.03.270. Epub 2023 Mar 23.
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.
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.
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).
The use of the Vivovitals platform may help to improve glycemic control among individuals with type 2 diabetes mellitus.
本研究旨在评估 Vivovitals 糖尿病平台通过在医生的监测和监督下为患者提供更便捷、直接的患者护理，改善血糖控制并降低未控制的 2 型糖尿病患者的糖化血红蛋白 (HbA1c) 水平。
这是一项为期 12 周、前瞻性、实用、单中心、双臂研究，评估了 Vivovitals 糖尿病平台对 78 名年龄≥18 岁、基线 HbA1c 水平≥7.5%（58mmol/mol）的成年人血糖控制的影响。参与者被随机分为两组。对照组接受常规临床护理，而干预组则提供智能手机链接的远程医疗应用程序、预配置血糖仪和血糖读数日记访问权限。干预组的血糖水平每天传输给提供者。对于血糖水平<70mg/dL 或>180mg/dL 的患者，会联系他们，并修改他们的饮食和药物。使用非参数检验比较两组在基线和 12 周时的结果，P<.05 被认为具有统计学意义。
在 12 周内，对照组的平均 HbA1c 水平降低了 0.474%（P =.533；95%CI，-0.425 至-0.523），而干预组的平均 HbA1c 水平降低了 1.70%（P =.002；95%CI，-1.02 至-2.39）。使用 Cohen d 表示估计的治疗差异，结果为 0.62。12 周后，对照组和干预组的 HbA1c 值之间具有统计学差异（P =.001）。
使用 Vivovitals 平台可能有助于改善 2 型糖尿病患者的血糖控制。
