Glucose Empowerment Through Monitoring and Social Support in Pregnancy
NCT ID: NCT07009704
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-07-01
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
Group 2- No group chat intervention
Participants in group 2 will be randomized to wear a real-time continuous glucose monitor for 14 days.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Tufts Medical Center
OTHER
Responsible Party
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Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Larissa Calancie
Role: primary
Other Identifiers
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