(P11-009-25) Glucose Empowerment Through Monitoring and Social Support in Pregnancy (GEMS-P) Pilot Study Protocol

Objectives: To test a theory-informed, mobile-based intervention aiming to increase glucose management self-efficacy among pregnant individuals at risk for hyperglycemia (i.e., BMI≥25, personal history of gestational diabetes, and/or primary family member with Type II Diabetes). Pilot study secondary outcomes of interest include neonatal adiposity, macrosomia, large-for-gestational-age, small-for-gestational age, motivation for glucose management, social support, pregnancy-specific stress, and prenatal care satisfaction.

Methods: We plan to randomize 70 pregnant individuals in early pregnancy ( < 20 weeks gestation) to an intervention or control group. The intervention group will be invited to wear a real-time continuous glucose monitor (Abbott Libre 3 Plus) for 14 days that is linked to a smartphone application that displays minute-by-minute blood glucose levels. The intervention group will also be invited to join a group chat for 60 days using the mobile-based Signal application and encouraged to support each other to manage glucose levels within a healthy range (60-125 mg/dL fasting or 70-180 mg/dL 2-hrs postprandial). The control group will receive the same intervention after the first group has completed the intervention. The intervention is informed by Self-Determination Theory and the concept of social support.

Results: We hypothesize that participants randomized to the intervention group will report significantly higher glucose management self-efficacy compared to the control group. We will measure glucose management self-efficacy using a validated survey for type II diabetes management (DMSES UK), adapted for pregnancy.

Conclusions: Study results and feasibility metrics will inform a larger, randomized controlled trial powered to test the joint and independent effects of the real-time continuous glucose monitoring and mobile-based social support via the group chat on neonatal adiposity.

Funding Sources: K12HD092535 from NIH/ NICHD and Tufts Building Interdisciplinary Research Careers in Women's Health (BIRCWH) K12 Career Development