Venkatesan Aarathi, Zimmermann Gretchen, Rawlings Kelly, Ryan Claudia, Voelker Louise, Edwards Caitlyn
Vida Health, San Francisco, CA, United States.
JMIR Form Res. 2023 Jan 13;0:e0. doi: 10.2196/41880.
The prevalence of diabetes remains high, with traditional lifestyle interventions demonstrating limited success in improving diabetes-related outcomes, particularly among individuals with diabetes-related mental health comorbidities. Digital health interventions provide the ability to ease the sustained and rigorous self-management needs associated with diabetes care and treatment. Current interventions though, are plagued by small sample sizes, underpowered pilot studies, and immense heterogeneity in program intervention, duration, and measured outcomes.
Therefore, this work aimed to evaluate the effectiveness of a mobile health diabetes management program on measures of glycemic control in a high-risk population with type 2 diabetes (hemoglobin A1c [HbA1c] ≥8.0%), utilizing a sample of 1128 participants who provided baseline and follow-up data. The sustainability of this change in glycemic control was examined in a subset of participants (n=455) at 6 months and 1 year following program enrollment. A secondary analysis examined changes in glycemic control among a subset of participants with self-reported mild-to-moderate depression at baseline.
This study utilized a single-arm, retrospective design. Participants were enrolled in the Vida Health Diabetes Management Program. This app-based intervention utilized one-on-one remote sessions with a health coach, registered dietitian nutritionist, and/or a certified diabetes care and education specialist and structured lessons and tools related to diabetes management and self-care. Participants provided baseline (-365 to 21 days of program enrollment) as well as follow-up (at least 90 days following program enrollment) HbA1c values. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up time points. The 8-item Patient Health Questionnaire and the 7-item Generalized Anxiety Disorder Scale were utilized to assess self-reported depressive and anxiety symptoms, respectively. Paired t tests and linear regression modeling accounting for pertinent covariates were used to evaluate changes in mental health symptom acuity and their relationship with changes in glycemic control.
We observed a significant decrease in HbA1c of -1.35 points between baseline (mean 9.84, SD 1.64) and follow-up (mean 8.48, SD 1.77; t=22.56, P<.001) among this large, high-risk sample. This decrease was sustained up to 1 year following program enrollment. Additionally, a significant relationship between improvements in depressive symptom acuity and improvements in HbA1c was observed (β=-0.74, P=.03).
This study demonstrates clinically meaningful improvements in glycemic control among participants enrolled in the Vida Health Diabetes Management Program. Additionally, this work presents one of the largest studied samples of participants enrolled in a digital health diabetes management program to date.
糖尿病的患病率仍然很高，传统的生活方式干预在改善糖尿病相关结局方面成效有限，尤其是在患有糖尿病相关心理健康合并症的个体中。数字健康干预能够满足糖尿病护理和治疗中持续且严格的自我管理需求。然而，目前的干预措施存在样本量小、试点研究效能不足以及项目干预、持续时间和测量结果存在巨大异质性等问题。
因此，本研究旨在评估一项移动健康糖尿病管理项目对2型糖尿病高危人群（糖化血红蛋白[HbA1c]≥8.0%）血糖控制指标的有效性，该研究样本包含1128名提供了基线和随访数据的参与者。在项目入组后的6个月和1年，对一部分参与者（n = 455）进行了血糖控制变化可持续性的检查。二次分析考察了基线时自我报告有轻度至中度抑郁的一部分参与者的血糖控制变化情况。
本研究采用单臂回顾性设计。参与者参加了Vida Health糖尿病管理项目。这种基于应用程序的干预通过与健康教练、注册营养师和/或认证糖尿病护理与教育专家进行一对一远程课程，并提供与糖尿病管理和自我护理相关的结构化课程和工具。参与者提供了基线（项目入组前365天至21天）以及随访（项目入组后至少90天）时的HbA1c值。采用配对t检验评估基线和随访时间点之间HbA1c的变化。分别使用8项患者健康问卷和7项广泛性焦虑障碍量表评估自我报告的抑郁和焦虑症状。采用配对t检验和考虑相关协变量的线性回归模型评估心理健康症状严重程度的变化及其与血糖控制变化的关系。
在这个大型高危样本中，我们观察到基线（平均9.84，标准差1.64）和随访（平均8.48，标准差1.77；t = 22.56，P <.001）之间HbA1c显著下降了1.35个百分点。项目入组后长达1年，这种下降一直持续。此外，还观察到抑郁症状严重程度的改善与HbA1c的改善之间存在显著关系（β = -0.74，P =.03）。
本研究表明，参加Vida Health糖尿病管理项目的参与者在血糖控制方面有具有临床意义的改善。此外，这项研究提供了迄今为止参与数字健康糖尿病管理项目研究的最大样本之一。
