Glucose Empowerment Through Monitoring and Social Support in Pregnancy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT07009704
Status
Recruiting
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Conditions

  • Gestational Diabetes
  • Pregnancy, Complications

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Mobile-based social support — BEHAVIORAL
    Participants will be invited to join an encrypted group chat where they will be encouraged to provide and receive social support related to glucose management during early pregnancy. Other study participants and study team members will be in the group chat.
  • Real-time continuous glucose monitoring — BEHAVIORAL
    Participants will receive a real-time continuous glucose monitor that pairs with an existing smartphone app that shows minute-by-minute glucose levels and records glucose levels in 5 minute increments.

Study Details

The purpose of the research is to learn whether wearing a continuous glucose monitor that shows blood glucose levels in real time on a smart phone app and participating in a group chat with other research participants will help participants keep a healthy blood glucose level during pregnancy. High levels of blood glucose during pregnancy can lead to health problems during and after pregnancy. It may also increase the risk for health problems for the developing baby. The investigators think our program might be a new way to help some people maintain a healthy blood glucose level during pregnancy. When pregnant people know their blood glucose levels are high, they can do things like exercise or drink water to bring their blood glucose levels down. They can also learn what foods to eat to maintain healthy blood glucose levels, and what foods to avoid. The investigators think being in a group chat with other pregnant individuals will allow participants to support and learn from each other. Pregnant individuals should also work with their healthcare providers to manage their blood glucose levels.

Key Dates

Start date
Jul 1, 2025
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1- Group chat intervention
    Participants in group 1 will be randomized to wear a real-time continuous glucose monitor for 14 days and participate in a secure mobile-based group chat where they will provide and receive social support for glucose management. Participants will be in the group chat for 60 days.
  • Experimental: Group 2- No group chat intervention
    Participants in group 2 will be randomized to wear a real-time continuous glucose monitor for 14 days.

Primary Outcome Measure

Self-efficacy for glucose management [ Time Frame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111
Larissa Calancie

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By research site
Tufts Medical Center· Boston, MA

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