Glucose Empowerment Through Monitoring and Social Support in Pregnancy

NCT07009704 | Recruiting

• 3 other identifiers: STUDY00005143K12HD092535K12AR084217
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy, Complications; Gestational Diabetes

Keywords

pregnancy; gestational diabetes; GDM; intervention; hyperglycemia; group chat; continuous glucose monitoring; mobile-based; behavioral change; CGM

Outcome Measures

Primary Outcomes (1)

• Self-efficacy for glucose management

  Self-efficacy will be adapted from a validated survey of self-efficacy for type II diabetes management (DMSES UK)

  Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study

Secondary Outcomes (4)

• Motivation for glucose management

  Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study

• Pregnancy-specific stress

  Baseline, Day 60 of study participation

• Social support

  Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 30 of group chat participation, Day 60 of study participation

• Pre-natal care satisfaction

  Baseline, Day 60 of study completion

Study Arms (2)

Group 1- Group chat intervention

EXPERIMENTAL

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.

Behavioral: Mobile-based social support; Behavioral: Real-time continuous glucose monitoring

Group 2- No group chat intervention

EXPERIMENTAL

Participants in group 2 will be randomized to wear a real-time continuous glucose monitor for 14 days.

Behavioral: Real-time continuous glucose monitoring

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.

Group 1- Group chat intervention

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.

Group 1- Group chat intervention; Group 2- No group chat intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current pregnancy a multiple gestation (e.g., twins)
• Smoked during this current pregnancy
• Active hepatitis or HIV infection
• Current pregnancy have any documented fetal congenital anomalies
• Current history of heroin, cocaine, crack, LSD, or methamphetamines
• Current history of alcohol abuse
• Previous gastric bypass
• Shift work that alters the sleep/wake periods
• Have known rheumatological or chronic inflammatory state (i.e., arthritis, inflammatory bowel disease)?
• Chronic illnesses, including diabetes and dialysis, that require regular medication use
• Uncontrolled hypothyroidism
• Known culture of positive chorioamnionitis?
• An adult who is unable to consent (e.g., cognitively impaired adults)
• Ward of the state
• Unable to read or write English

Sponsors & Collaborators

• Tufts Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications; Diabetes, Gestational; Hyperglycemia

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Larissa Calancie, PhD

CONTACT

(617) 636-0976; larissa.calancie@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two groups. Group 1 will receive real-time continuous glucose monitoring plus mobile-based social support. Group 2 will only receive real-time continuous glucose monitoring.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: June 8, 2025
• Study Start: July 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)