NCT05662462 Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
| NCT ID | NCT05662462 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Pre-Gestational Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2024-07-11 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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).
Contact & Investigator
Naleef Fareed, PhD, MBA
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT05662462 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pre-Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05662462 currently recruiting?
Yes, NCT05662462 is actively recruiting participants. Contact the research team at kartik.venkatesh@osumc.edu for enrollment information.
Where is the NCT05662462 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT05662462 clinical trial?
NCT05662462 is sponsored by Ohio State University. The principal investigator is Naleef Fareed, PhD, MBA at Ohio State University. The trial plans to enroll 124 participants.
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