Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University
About this trial
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
Qualifiers
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;
Disqualifiers
None
Trial design
Treatments tested in this trial
- DEXCOM G7 PRO Continuous Glucose Monitor
- Patient mHealth app linked to a provider dashboard
- Care team coaching for medical and social needs (HUB)
- Provider dashboard
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ohio State University
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator
DexCom, Inc.
Collaborator
Source ClinicalTrials.gov