Recruiting

Glucose Monitoring

Sponsor:

Tufts Medical Center

Code:

NCT07009704

Conditions

Pregnancy, Complications

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Mobile-based social support

Real-time continuous glucose monitoring

Study Details

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

Study ID

NCT07009704

Start date

Jul 1, 2025

Status verified date

Sep, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Mobile-based social support

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

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.

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 and Locations

Central contacts

Larissa Calancie, PhD

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

Locations

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

More Information

Sponsor

Tufts Medical Center

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts Medical Center on 2025-09-22.