Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
Launched by OHIO STATE UNIVERSITY · Dec 14, 2022
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The ACHIEVE clinical trial is studying how a new mobile health app, combined with continuous glucose monitoring and support from a care team, can help pregnant women with type 2 diabetes control their blood sugar levels more effectively than standard care methods. The goal is to see if using this technology can help more women achieve a healthy blood sugar target by the third trimester of their pregnancy. The researchers believe that using this approach will help 25% more participants reach the target compared to those receiving regular prenatal care.
To be eligible for this study, participants need to be pregnant women aged 18 or older, in their first 20 weeks of pregnancy, with a diagnosis of type 2 diabetes and a specific blood sugar measurement. They must have Medicaid insurance, speak English or Spanish, and have access to a smartphone with internet. Participants will use the mobile app to track their blood sugar levels, schedule appointments, and communicate with their healthcare providers. They will also allow the study team to access their health records and monitor their healthcare visits during the trial. This study is currently recruiting participants, so if you or someone you know fits the criteria, it could be a great opportunity to improve diabetes management during pregnancy.
Gender
FEMALE
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 Ohio State University
The Ohio State University (OSU) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a commitment to improving patient care and outcomes, OSU leverages its extensive resources, interdisciplinary collaboration, and expertise in diverse medical fields. The university fosters an environment of rigorous scientific inquiry, ensuring that clinical trials are conducted with the highest ethical standards and adherence to regulatory guidelines. Through its Clinical Trials Office, OSU aims to translate groundbreaking research into practical applications, benefiting both local and global communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
Patients applied
Trial Officials
Naleef Fareed, PhD, MBA
Principal Investigator
Ohio State University
Joshua J Joseph, MD
Principal Investigator
Ohio State University
Kartik K Venkatesh, MD, PhD
Principal Investigator
Ohio State University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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