NCT05662462Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 22 Nov 2022
- Start date
- 11 Jul 2024
- Primary completion date
- May 2028
- Lead sponsor
- Ohio State University
- Diseases
- Type 2 diabetes
- NCT number
- NCT05662462
What you commit to
- Study type: Interventional
- Planned participants: 124
- From 11 Jul 2024 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.