Improving blood sugar control during pregnancy for women with type 2 diabetes using technology and coaching

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.