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

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

Conditions

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

Interventions

DEVICE

DEXCOM G7 PRO Continuous Glucose Monitor

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.

DEVICE

Patient mHealth app linked to a provider dashboard

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.

BEHAVIORAL

Care team coaching for medical and social needs (HUB)

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.

DEVICE

Provider dashboard

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.

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ)

  collaborator FED

• DexCom, Inc.

  collaborator INDUSTRY

• Ohio State University

  lead OTHER

Principal Investigators

• Naleef Fareed, PhD, MBA · Ohio State University

• Joshua J Joseph, MD · Ohio State University

• Kartik K Venkatesh, MD, PhD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-11

Primary Completion

2028-05-31

Completion

2029-03-31

FDA Device

Yes

Countries

• United States

Study Locations