**Background:** Type 2 diabetes (T2D) complicates over 100,000 pregnancies annually in the USA and is projected to affect 1 in 20 pregnancies within 10 years. Inadequate glycemic control increases the risk of adverse outcomes—including severe maternal morbidity, preeclampsia, cesarean delivery, large-for-gestational-age birth, preterm birth, and neonatal hypoglycemia—by at least two-fold. Guidelines recommend achieving an A1c target <6.5% in pregnancy. Medicaid-insured pregnant individuals bear a disproportionate burden of T2D, adverse outcomes, and unmet social needs such as food insecurity and unstable housing. Mobile health applications, provider dashboards, continuous glucose monitoring (CGM), and social needs interventions have each been independently associated with improved glycemic control in non-pregnant populations, but their combined effect in pregnancy has not been evaluated.
**Methods:** ACHIEVE is a two-arm, randomized, controlled, single-center superiority trial at The Ohio State University (Midwestern USA). The trial will recruit 124 Medicaid-insured pregnant individuals with T2D, ≤20 weeks gestation, with A1c ≥6.5% (assessed within 12 weeks of randomization or prenatal care enrollment). Participants must be ≥18 years, English or Spanish speaking, own or be provided a smartphone, and be available for longitudinal follow-up through delivery. Exclusion criteria include inability to consent, concurrent enrollment in another glycemic control trial, or inability to read/write in English or Spanish. Recruitment will occur over 3 years via EHR screening, clinic flyers, and community provider referrals.
Participants are randomized 1:1 to intervention or standard care. The intervention group receives: (1) a patient mHealth app providing education, reminders, care goals, CGM data summaries, PRO assessments, and secure messaging; (2) a bidirectional provider dashboard displaying participant goals, care pathways, and recommendations; (3) DEXCOM G7 CGM sensors (replaced every 10 days) with data reviewed by a certified diabetes care and education specialist at least twice weekly; (4) social needs screening using the Accountable Health Communities tool, with referrals to Health Impact Ohio’s Central Ohio Pathways Hub, where community health workers connect participants to community resources via defined care pathways; and (5) team-based care from physicians, nurses, certified diabetes care and education specialists, clinical social workers, and CHWs. The standard care group receives current integrated diabetes and prenatal care, including weekly self-monitored blood glucose logs (paper, sent to EHR), communication via Epic MyChart, and A1c and PRO assessments at similar intervals.
**Key Results:** The primary outcome is the proportion of individuals achieving A1c <6.5% by delivery (using the value most proximate to delivery). The trial is powered to detect a 25% absolute increase (64% intervention vs 39% control), requiring 124 participants (62 per arm) for 80% power (one-sided Fisher’s exact test, accounting for 10% loss to follow-up). Secondary outcomes include: large-for-gestational-age birth (>90th percentile), neonatal hypoglycemia (blood glucose <30 mg/dL), hypertensive disorders of pregnancy, NICU admission, preterm birth <37 weeks, and respiratory distress syndrome. For the intervention group, CGM metrics include time in range (63–140 mg/dL), mean glucose, area under the curve, and hypoglycemia/hyperglycemia indices. Patient-reported outcomes assessed at randomization, during pregnancy, and at delivery include: Patient Activation Measure, health literacy (Short Assessment of Health Literacy-Spanish and English, eHealth Literacy Scale), diabetes knowledge (Diabetes Knowledge Questionnaire), diabetes distress (Diabetes Distress Scale), self-efficacy (Diabetes Management Self-Efficacy Scale), medication adherence (Morisky Medication Adherence Scale), provider–patient communication (Doctor-Patient Communication Scale), and social needs (Accountable Health Communities screening tool). Healthcare utilization (prenatal visits, hospitalizations, ED visits, triage visits) will be abstracted from EHR and surveys. Engagement data (app usage, social needs referrals completed) will be collected for the intervention group.
Primary analysis follows intention-to-treat. Subgroup analyses are planned for race/ethnicity, BMI, gestational age, and baseline A1c. Exploratory mediation analyses will assess intermediate outcomes. No interim analyses are planned. Multiple imputation will be used for missing covariates. Participants in both arms receive $100/month compensation for completing study activities.
**Clinical Implications:** If the ACHIEVE intervention demonstrates efficacy, it would provide an integrated, scalable model of care that addresses both medical management and social determinants of health for a high-risk, underserved population. The intervention is embedded within existing electronic platforms (REDCap, EHR) and an established community health worker hub model (Central Ohio Pathways Hub), supporting potential dissemination. The study is limited by its non-blinded design (though laboratory staff and biostatistician are blinded), single-center setting, focus on pregnancy only (not periconception or postpartum), and powering for glycemic control rather than adverse pregnancy outcomes directly. Nonetheless, T2D in pregnancy is a frequent and growing problem, and an effective multicomponent intervention could have substantial public health impact by advancing health equity for Medicaid-insured pregnant individuals.