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Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
Who can join
Ages 18 and older · Women
Full eligibility criteria
Inclusion Criteria: 1. pregnant individuals age ≥18 years; 2. ≤20 weeks of gestation (specifically, \<20+6 weeks); 3. diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment; 4. Medicaid insurance; 5. English or Spanish speaking; 6. cognitively able to complete the study requirements; 7. consent to all study activities; 8. accessible for participation in study activities; 9. use a smartphone with internet access; Participants must also consent to the study team abstracting information from their electronic health records (EHRs), using CGM for glucose monitoring if randomized to the intervention group, tracking the participants' clinic, hospital, and emergency room visits during the study period, as well as tracking the number of times the participants use the ACHIEVE mobile health (mHealth) application (app), including what activities are used in the mobile application (e.g., recording blood glucose, scheduling appointments, messaging their healthcare providers, accessing educational resources).
About the study
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
What is being tested
- DEXCOM G7 PRO Continuous Glucose Monitor (device)
- Patient mHealth app linked to a provider dashboard (device)
- Care team coaching for medical and social needs (HUB) (behavioral)
- Provider dashboard (device)
Sponsor: Ohio State University · Participants: 124 · Started: Jul 11, 2024
Contact the study team
- Kartik Venkatesh, MD, PhD · Phone: 614-293-2222
Official record on ClinicalTrials.gov — NCT05662462
Locations in the U.S.
| Ohio | The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.