ACHIEVE: Successfully achieving and maintaining euglycemia during pregnancy for type 2 diabetes through technology and coaching

项目摘要 妊娠期2型糖尿病(T2D)会增加母亲和婴儿的不良结局风险。完毕 患有T2D的婴儿中，每3个婴儿中就有1个会经历不良结局，包括妊娠大 出生年龄、早产、出生创伤、新生儿低血糖和死产。严格控制产妇血糖 在整个怀孕期间是优化围产期结局的关键。通过胰岛素药物治疗，这是可能的， 警惕的血糖监测，包括饮食和锻炼在内的生活方式改变，以及基于团队的产前护理。 参加医疗补助的患有T2D的孕妇经历了非医疗社交需求，限制了他们的能力 实现血糖控制，包括缺乏可靠的交通工具来参加产前检查，获得资源 进行饮食和运动的改变，以及记录自我监测的血糖值和调整的便捷方法 胰岛素剂量。需要一种基于提供者和患者的多方面方法，并采用行之有效的策略来 改善血糖控制。我们建议“实现：成功实现并维持正常血糖。 在妊娠期通过技术和指导治疗2型糖尿病。我们的干预是多方面的- 组件，包括移动健康(MHealth)应用程序(APP)、提供商仪表板、Dexcom连续 血糖监测(CGM)，以及医疗和社会需求的护理团队教练。这一干预赋予了 接受医疗补助的患有T2D的孕妇和他们的医疗保健提供者实现和维持血糖 控制，改善获得护理的机会，并提供患者教育和支持。的每个子组件 建议的干预以社会认知理论(SCT)为基础，强调个人的技能， 知识和信念，以及自我效能感，以实现血糖控制。我们提出了三个目标：目标1：发展 为患有T2D的已登记Medicaid的孕妇量身定做的实现mHealth应用程序和提供商仪表板 和他们的医疗团队通过积极的利益相关者参与；目标2：进行RCT并衡量 干预效果(带有CGM的mHealth应用程序、提供者仪表板和护理团队指导)与 目前的标准护理(产前检查、自我监测血糖以及经认证的糖尿病护理和教育 专家)，以实现血糖控制(血红蛋白A1c&lt；6.5%在妊娠晚期)。我们假设是25% 干预组中达到目标血红蛋白的参与者比例绝对增加 A1C&lt；与标准护理组相比，晚期妊娠期A1C&lt；6.5%；目标3：识别多层次患者和 提供者和促进者对干预措施及其子组件的满意度、参与度和使用设置障碍。

Project Summary Type 2 diabetes (T2D) in pregnancy increases the risk of adverse outcomes for both the mother and infant. Over 1 in 3 infants born to individuals with T2D will experience an adverse outcome, including large for gestational age at birth, preterm birth, birth trauma, neonatal hypoglycemia, and stillbirth. Strict maternal glycemic control throughout pregnancy is key to optimizing perinatal outcomes. This is possible with insulin pharmacotherapy, vigilant glucose monitoring, lifestyle modifications including diet and exercise, and team-based prenatal care. Medicaid-enrolled pregnant individuals with T2D experience non-medical social needs that limit their ability to achieve glycemic control, including lack of reliable transportation to attend prenatal visits, access to resources to engage in diet and exercise changes, and convenient methods to log self-monitored glucose values and adjust insulin dosing. A multi-faceted provider-patient based approach is needed with proven strategies to improve glycemic control. We propose “ACHIEVE: Successfully achieving and maintaining euglycemia during pregnancy for type 2 diabetes through technology and coaching.” Our intervention is multi- component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. This intervention empowers Medicaid-enrolled pregnant individuals with T2D and their healthcare providers to achieve and maintain glycemic control, improve access to care, and provide patient education and support. Each sub-component of the proposed intervention is grounded in Social Cognitive Theory (SCT), and emphasizes on individuals’ skills, knowledge and beliefs, and self-efficacy to achieve glycemic control. We propose three aims: AIM 1: Develop the tailored ACHIEVE mHealth app and provider dashboard for Medicaid-enrolled pregnant individuals with T2D and their healthcare team through active stakeholder engagement; AIM 2: Conduct an RCT and measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c <6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c <6.5% in the third trimester compared to the standard care group; and AIM 3: Identify multi-level patient and provider barriers and facilitators to satisfaction, engagement, and use of the intervention and its subcomponents.