Actively Recruiting
Led by Ohio State University · Updated on 2025-05-29
124
Participants Needed
1
Research Sites
43 weeks
Total Duration
O
Ohio State University
Lead Sponsor
A
Agency for Healthcare Research and Quality (AHRQ)
Collaborating Sponsor
This research aims to improve blood sugar control in pregnant individuals with type 2 diabetes who are enrolled in Medicaid. The trial evaluates a multi-component intervention including a mobile health app connected to a continuous glucose monitor (CGM), a provider dashboard, and care team coaching compared to the current standard care of prenatal visits, self-monitored blood glucose, and support from certified diabetes care specialists. The study focuses on achieving better glycemic control measured by hemoglobin A1c levels below 6.5% in the third trimester to reduce risks of adverse outcomes for mother and infant. Participants in the intervention group will use the DEXCOM G7 PRO CGM device, which automatically tracks glucose levels and syncs data to the mHealth app. The app offers education, reminders, goal setting, messaging, and video conferencing. Care team coaching addresses medical and social needs through a referral system called the HUB, which connects participants to community resources. The provider dashboard allows healthcare teams to monitor and adjust care plans. The control group will receive standard care including prenatal visits and self-monitoring without the digital tools. During the study, participants will complete regular assessments including blood glucose monitoring, questionnaires on diabetes knowledge, medication adherence, health literacy, and social needs screening. Data on pregnancy outcomes like birth size, preterm birth, and neonatal hypoglycemia will be collected. The primary outcome is the proportion of participants achieving target A1c levels before delivery. The study involves continuous monitoring from early pregnancy until delivery, with follow-up on maternal health after birth, lasting approximately five months through gestation.
CONDITIONS
Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 months from ≤20 weeks of gestation to delivery
Participants use a mobile health app, continuous glucose monitoring device, provider dashboard, and receive care team coaching to manage type 2 diabetes during pregnancy.
Regular prenatal visits with additional study-related remote monitoring and coaching
Duration - 6 to 12 months postpartum
Participants are monitored for diabetes and reproductive health outcomes 6 to 12 months after delivery.
Visits scheduled as needed for postpartum assessments
Total: 1 location
1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Actively Recruiting
K
Kartik Venkatesh, MD, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Kartik K Venkatesh, Joshua J Joseph, Christine Swoboda...
https://pubmed.ncbi.nlm.nih.gov/37164461