Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
Recruiting now · Not applicable
Conditions studied: Pre-Gestational Diabetes, Type2diabetes, Pregnancy in Diabetic, Pregnancy, High Risk
In brief
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
Key facts
- Study ID
- NCT05662462
- Run by
- Ohio State University
- People needed
- 124
- Starts
- 2024-07-11
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- pregnant individuals age ≥18 years;
- ≤20 weeks of gestation (specifically, <20+6 weeks);
- diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;
- Medicaid insurance;
- English or Spanish speaking;
- cognitively able to complete the study requirements;
- consent to all study activities;
- accessible for participation in study activities;
- 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).
Where it is running
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.