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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT05662462
Status
Recruiting
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Conditions

  • Pre-Gestational Diabetes
  • Pregnancy in Diabetic
  • Pregnancy, High Risk
  • Type2diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DEXCOM G7 PRO Continuous Glucose Monitor — DEVICE
    Participants in the intervention arm will be provided with DEXCOM® G7 PRO CGM sensors and transmitters. The Dexcom G7 CGM system is accurate and safe in pregnant individuals with diabetes. Participants will be taught how to place and remove CGM sensors by a trained research nurse, and will be given sensors to change themselves at home every 10 days. Of note, the DEXCOM® G7 PRO can be applied as a patch on the abdomen, arm, or upper buttocks, is well-tolerated in pregnancy, and does not require calibration. Our mHealth app will allow for wireless synchronization with the CGM sensor so that data are seamlessly reported back to the healthcare team.
  • Patient mHealth app linked to a provider dashboard — DEVICE
    The mHealth app is based on our team's prototype intervention developed at our study site. The mHealth app provides diverse functions, including education, reminders, care goals, care pathway recommendations, CGM data and PROs reporting and monitoring, messaging and video conferencing, and a calendar function. Content is based on clinical guidelines for diabetes in pregnancy. Participants will be directed to appropriate resources and online learning to help them navigate the app and its resources. PROs in the mHealth app will be embedded to address health and social needs, and rule-based algorithms will provide tailored care goals, show care pathways, and establish the frequency of elicited PROs.
  • Care team coaching for medical and social needs (HUB) — BEHAVIORAL
    Participants will be screened at enrollment and throughout the intervention for social needs using a survey adapted from validated instruments, such as the Accountable Health Communities Health-Related Social Needs Screening Tool. The care team will refer participants with affirmative responses to the HUB through the provider dashboard to address social needs (e.g., food insecurity, housing, employment). HUB community health workers will perform comprehensive social needs assessments and connect participants to community resources through "care pathways," a defined action plan addressing patient needs which is recorded and tracked.
  • Provider dashboard — DEVICE
    The ACHIEVE intervention will include a bi-directional dashboard that displays information about individuals, including priority care goals and pathways, and recommendations generated via PROMPT. Healthcare team members can access the dashboard embedded within a portal to modify or update information and close the loop on participant tasks. The dashboard will present recommendations for participant goals and pathways provided by the PROMPT algorithms. Providers can use these recommendations or manually select ones for the participant. Providers can sequence goals and pathways by level of complexity. Both the HUB and the healthcare team can perform ongoing assessments of HUB pathway selections and assess recurring needs through the provider dashboard.

Study Details

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

Key Dates

Start date
Jul 11, 2024
Status verified
May 2025
Primary completion
May 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

The primary clinical outcome is the proportion of participants with an A1c <6.5% in the third trimester before delivery [ Time Frame: From ≤20 weeks of gestation to delivery, an average of 5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210
Kartik Venkatesh, MD, PhD
[email protected]
614-293-2222

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By research site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine· Columbus, OH

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