ACHIEVE Trial Evaluating Technology and Coaching to Improve Type 2 Diabetes Management During Pregnancy

What this Trial Is About

Type 2 diabetes during pregnancy increases risks for both mother and infant, including large birth size, preterm birth, and other complications. This trial evaluates a multi-component intervention involving a mobile health app, continuous glucose monitoring CGM, a provider dashboard, and care team coaching compared to standard care, aiming to improve blood sugar control in Medicaid-enrolled pregnant individuals with type 2 diabetes. The study seeks to increase the proportion of participants achieving target hemoglobin A1c levels below 6.5% in the third trimester. Participants are randomly assigned to either the intervention group, which uses the mHealth app linked to CGM and provider support, or the standard care group receiving prenatal visits, self-monitoring of blood glucose, and certified diabetes care education. The intervention includes CGM sensors changed every 10 days at home and continuous support addressing medical and social needs via a care team and provider dashboard. The study also tracks usage of the app and care activities throughout pregnancy. During the study, participants undergo regular monitoring of blood glucose and health outcomes, including assessments conducted once per trimester and continuous data collection from randomization until delivery. Researchers will measure glycemic control, pregnancy outcomes, patient engagement, health literacy, and social needs. The study lasts through pregnancy, with follow-up data collected up to 6 to 12 months postpartum to assess diabetes and reproductive health outcomes.

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