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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

• 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).

Locations
United States
Ohio
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
RECRUITING
Columbus
Contact Information
Primary
Kartik Venkatesh, MD, PhD
kartik.venkatesh@osumc.edu
614-293-2222
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2029-03
Participants
Target number of participants: 124
Treatments
Active_comparator: ACHIEVE Intervention
The intervention includes a multi-component, including a mobile health (mHealth) application (app), provider dashboard, DEXCOM continuous glucose monitoring (CGM), and care team coaching for medical and social needs. The intervention group will also receive standard of care as described below.
No_intervention: Standard of care
Standard of care includes prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist support.
Related Therapeutic Areas
Sponsors
Collaborators: DexCom, Inc., Agency for Healthcare Research and Quality (AHRQ)
Leads: Ohio State University

This content was sourced from clinicaltrials.gov