Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During Pregnancy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Pregnant (\<20w0d)

• At least 18 years to 45 years old

• BMI \>25, personal history of GDM, or first-degree family member with type II diabetes

• Comfortable conversing in English

• Own a smartphone and willing to use the CGM app and Signal

• Receiving prenatal care and planning to deliver at Tufts Medicine (Boston)

• Signed the consent form

• Currently located in the United States

Locations
United States
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Contact Information
Primary
Larissa Calancie, PhD
larissa.calancie@tufts.edu
(617) 636-0976
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 70
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Tufts Medical Center

This content was sourced from clinicaltrials.gov