RecruitingNot Applicable

Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching

United States124 participantsStarted 2024-07-11

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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;

What they're measuring

The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery

Timeframe: From ≤20 weeks of gestation to delivery, an average of 5 months

Trial details

NCT IDNCT05662462

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Contact for this trial

Kartik Venkatesh, MD, PhD

614-293-2222 kartik.venkatesh@osumc.edu

View on ClinicalTrials.gov More Pre-Gestational Diabetes trials