Recruiting

Euglycemia Coaching

Sponsor:

Ohio State University

Code:

NCT05662462

Conditions

Pre-Gestational Diabetes

Type2diabetes

Pregnancy in Diabetic

Pregnancy, High Risk

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Study ID

NCT05662462

Start date

Jul 11, 2024

Status verified date

Jun, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. pregnant individuals age ≥18 years;
2. ≤20 weeks of gestation (specifically, <20+6 weeks);
3. diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;
4. Medicaid insurance;
5. English or Spanish speaking;
6. cognitively able to complete the study requirements;
7. consent to all study activities;
8. accessible for participation in study activities;
9. 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).

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

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.

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 and Locations

Central contacts

Kartik Venkatesh, MD, PhD

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

Locations

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kartik Venkatesh, MD, PhD

614-293-2222Kartik.Venkatesh@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • mHealth
  • Pregnancy
  • Type 2 diabetes
  • Continuous glucose monitoring
  • Mobile application
  • Medicaid
  • Glycemic control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-06-29.