ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching

Over one in three infants born to individuals with type 2 diabetes (T2D) will experience an adverse outcome, including large for gestational age at birth, preterm birth, birth trauma, neonatal hypoglycemia, and stillbirth. Additionally, pregnant individuals with T2D suffer their own adverse outcomes, including increased rates of preeclampsia, cesarean delivery, severe maternal morbidity, and death compared with those without T2D. Outcomes improve with strict maternal glycemic control throughout pregnancy, a goal that may be difficult to achieve. For individuals enrolled in Medicaid, the ability to maintain glycemic control is hampered by a lack of reliable transportation for prenatal visits, access to resources for diet and exercise changes, and convenient methods to log glucose values and adjust insulin. In addition, those enrolled in Medicaid insurance are less likely to have periconception care, have higher hemoglobin A1c (A1c) levels, and are up to 80 percent more likely to have an infant with a congenital anomaly compared to those with private insurance. The use of technology has the potential to improve glycemic control and health equity.

This research will develop and evaluate the ACHIEVE intervention. This multicomponent intervention will include a mHealth app, a provider dashboard, continuous glucose monitoring (CGM), and team-based coaching for medical and social needs. Each sub-component of ACHIEVE will be grounded in social cognitive theory that emphasizes an individual's skills, knowledge and beliefs, and self-efficacy. The principles of user-centered design approach will be used in the design of the mHealth app and provider dashboard.

The specific aims of the research are the following:

• Develop the tailored ACHIEVE mHealth app and provider dashboard for Medicaid-enrolled pregnant individuals with T2D and their healthcare team.
• Conduct a randomized controlled trial and measure the effect of the intervention.
• Identify multi-level patient and provider barriers and facilitators to satisfaction, engagement, and use of the intervention and its subcomponents.

The mHealth app will be based on an existing prototype developed by the researchers that incorporates current clinical guidelines and provides education, reminders, care goals, care pathway recommendations, CGM data, patient-reported outcome (PRO) data reporting and monitoring, messaging and video conferencing, and calendar functionality. Data from the mHealth app will be transferred to an existing platform called PROMPT: Patient-Reported Outcomes Measurement Prioritization Tool. The PROMPT platform will display data on a provider dashboard for easier visualization and monitoring.  Recommendations will be provided to both patients and providers on care goals and pathways. Participants in the trial will be screened throughout the intervention for social needs—such as food insecurity, housing, and employment—with the care team referring patients to appropriate community-based resources to have their social needs addressed through the Central Ohio Pathways Hub managed by Health Impact Ohio.

A randomized controlled trial (RCT) will be conducted to measure the effectiveness of ACHIEVE, randomizing participants to ACHIEVE versus standard of care.  Among the inclusion criteria for the RCT will be pregnant individuals with Medicaid insurance, age 18 and older, 20 and fewer weeks gestation, a diagnosis of pregestational T2D and A1c of 6.5 percent and greater, no current use of a CGM, and English or Spanish speaking. The primary outcome will be meeting a target A1c less than 6.5 percent by delivery in the intervention arm compared to the control arm. Secondary outcomes to be measured include large for gestational age, neonatal hypoglycemia, neonatal intensive care admission for any indication, preterm birth, and respiratory distress syndrome, as well as PROs. A mixed methods evaluation will then be conducted to identify barriers and facilitators of implementation and uptake of ACHIEVE amongst those that participated in the RCT.  

This multicomponent approach to assist high-risk pregnant patients living with T2D to achieve and maintain euglycemia during pregnancy has the potential to empower patients and their providers to improve glycemic control, improve access to prenatal diabetes care, and improve patient education and support for social needs in pregnancy