Improving blood sugar control during pregnancy for women with type 2 diabetes using technology and coaching
ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
NA · Ohio State University · NCT05662462
This study is testing whether using a mobile app and coaching can help pregnant women with type 2 diabetes better control their blood sugar compared to regular prenatal care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05662462 on ClinicalTrials.gov |
What this trial studies
The ACHIEVE project aims to enhance glycemic control in pregnant individuals with type 2 diabetes by utilizing a mobile health application, continuous glucose monitoring, and care team coaching. This intervention will be compared to standard prenatal care to assess its effectiveness in achieving a target hemoglobin A1c of less than 6.5% during the third trimester. The study focuses on addressing non-medical social needs that hinder glycemic control, particularly among Medicaid-enrolled participants. By integrating technology and personalized support, the study seeks to empower patients and improve maternal and infant health outcomes.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals aged 18 and older with pregestational type 2 diabetes and an A1c of 6.5% or higher, enrolled in Medicaid.
Not a fit: Patients who are not pregnant or those with type 2 diabetes not enrolled in Medicaid may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce adverse pregnancy outcomes for women with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with technology-assisted interventions for diabetes management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Naleef Fareed, PhD, MBA — Ohio State University
- Study coordinator: Kartik Venkatesh, MD, PhD
- Email: kartik.venkatesh@osumc.edu
- Phone: 614-293-2222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pre-Gestational Diabetes, Type2diabetes, Pregnancy in Diabetic, Pregnancy, High Risk, mHealth, Pregnancy, Type 2 diabetes, Continuous glucose monitoring