Actively Recruiting
Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
Led by Ohio State University · Updated on 2025-05-29
124
Participants Needed
1
Research Sites
242 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
A
Agency for Healthcare Research and Quality (AHRQ)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The ACHIEVE RCT will measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c \<6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c \<6.5% in the third trimester compared to the standard care group
CONDITIONS
Official Title
Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant individuals age 18 years or older
- Pregnancy less than 20 weeks gestation (under 20 weeks and 6 days)
- Diagnosed with pregestational type 2 diabetes and A1c of 6.5% or higher at enrollment
- Have Medicaid insurance
- Speak English or Spanish
- Able to complete study requirements cognitively
- Consent to participate in all study activities
- Accessible for study participation
- Use a smartphone with internet access
- Consent to electronic health record data use, CGM monitoring if assigned, and tracking of clinic visits and app usage
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
K
Kartik Venkatesh, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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