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

实现：通过技术和指导成功实现并维持 2 型糖尿病妊娠期间血糖正常

• 批准号: 10706539
• 负责人: Naleef Fareed
• 金额: $ 39.4万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10706539
• 关键词: ACHIEVE; Successfully; achieving; maintaining; euglycemia

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.

项目摘要 妊娠期2型糖尿病（T2 D）增加了母亲和婴儿不良结局的风险。超过 1/3的T2 D患者所生婴儿将经历不良结局，包括妊娠期大 出生年龄、早产、产伤、新生儿低血糖和死产。严格的母体血糖控制 在整个怀孕期间，这是优化围产期结局的关键。胰岛素药物治疗可以做到这一点， 警惕的葡萄糖监测，生活方式的改变，包括饮食和锻炼，以及基于团队的产前护理。 接受医疗补助的T2 D妊娠患者经历的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进行产前检查，获得资源 参与饮食和锻炼的变化，以及记录自我监测的葡萄糖值和调整 胰岛素给药。需要一个多方面的基于提供者-患者的方法，并采用经证实的策略， 改善血糖控制。我们提出“ACHIEVE：成功地实现和维持健康 在怀孕期间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，包括移动的健康（mHealth）应用程序（app）、提供商仪表板、DEXCOM连续 血糖监测（CGM）和医疗和社会需求的护理团队辅导。这种干预使 接受医疗补助的T2 D妊娠患者及其医疗保健提供者，以达到和维持血糖水平 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 建议的干预措施以社会认知理论为基础，强调个人的技能， 知识和信念，以及自我效能，以实现血糖控制。我们提出三个目标：目标1：发展 为参加Medicaid的T2 D孕妇定制的ACHIEVE mHealth应用程序和提供者仪表板 目标2：开展随机对照试验， 干预效果（带有CGM的移动健康应用程序、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、自我监测血糖和经认证的糖尿病护理和教育 专家）实现血糖控制（晚期妊娠血红蛋白A1 c <6.5%）。我们假设有25% 干预组中达到目标血红蛋白的受试者比例的绝对增加 与标准护理组相比，晚期妊娠A1 c <6.5%;以及AIM 3：识别多节段患者， 提供者的障碍和促进者的满意度，参与度和使用的干预措施及其子组件。

项目成果

An Evidence-Based Framework for Creating Inclusive and Personalized mHealth Solutions-Designing a Solution for Medicaid-Eligible Pregnant Individuals With Uncontrolled Type 2 Diabetes.

用于创建包容性和个性化移动医疗解决方案的循证框架 - 为符合医疗补助资格、患有不受控制的 2 型糖尿病的孕妇设计解决方案。

• DOI: 10.2196/46654
• 发表时间: 2023-10-12
• 期刊: JMIR diabetes

Developing and testing an integrated patient mHealth and provider dashboard application system for type 2 diabetes management among Medicaid-enrolled pregnant individuals based on a user-centered approach: Mixed-methods study.

• DOI: 10.1177/20552076221144181
• 发表时间: 2023-01
• 期刊: DIGITAL HEALTH
• 影响因子: 3.9
• 作者: Fareed, Naleef;Swoboda, Christine;Singh, Priti;Boettcher, Emma;Wang, Yiting;Venkatesh, Kartik;Strouse, Robert
• 通讯作者: Strouse, Robert

Differences in Hemoglobin A1c during Pregnancy between Non-Hispanic Black versus White Women with Prepregnancy Diabetes.

患有孕前糖尿病的非西班牙裔黑人与白人女性怀孕期间糖化血红蛋白的差异。

• DOI: 10.1055/a-1788-5600
• 发表时间: 2022
• 期刊: American journal of perinatology
• 影响因子: 2
• 作者: Venkatesh,KartikK;Fareed,Naleef;Kiefer,MirandaK;Ware,CourtneyA;Buschur,Elizabeth;Landon,MarkB;Thung,StephenF;Costantine,MagedM;Gabbe,StevenG;Joseph,JoshuaJ
• 通讯作者: Joseph,JoshuaJ

Association of a large-for-gestational-age infant and maternal prediabetes mellitus and diabetes mellitus 10 to 14 years after delivery in the Hyperglycemia and Adverse Pregnancy Outcome Follow-up Study.

在高血糖和不良妊娠结局随访研究中，大于胎龄婴儿和母亲的糖尿病前期和分娩后 10 至 14 年糖尿病之间的关联。

• DOI: 10.1016/j.ajog.2023.02.017
• 发表时间: 2023
• 期刊: American journal of obstetrics and gynecology
• 影响因子: 9.8
• 作者: Venkatesh,KartikK;Grobman,WilliamA;Wu,Jiquiang;Catalano,Patrick;Landon,Mark;Scholtens,Denise;Lowe,WilliamL;Khan,SadiyaS
• 通讯作者: Khan,SadiyaS

Association Between Social Vulnerability and Achieving Glycemic Control Among Pregnant Individuals With Pregestational Diabetes.

妊娠前糖尿病孕妇的社会脆弱性与实现血糖控制之间的关联。

• DOI: 10.1097/aog.0000000000004727
• 发表时间: 2022
• 期刊: Obstetrics and gynecology
• 影响因子: 7.2
• 作者: Venkatesh,KartikK;Germann,Katherine;Joseph,Joshua;Kiefer,Miranda;Buschur,Elizabeth;Thung,Stephen;Costantine,MagedM;Gabbe,Steven;Grobman,WilliamA;Fareed,Naleef
• 通讯作者: Fareed,Naleef