Glucose Empowerment Through Monitoring and Social Support in Pregnancy (GEMS-P)

Tufts University

Status: Enrolling

Conditions: Gestational Diabetes; Pregnancy, Complications

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07009704

STUDY00005143 (Other Identifier)

K12HD092535 (U.S. NIH Grant/Contract)

K12AR084217 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group 1- Group chat intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mobile-based social support

Behavioral: Real-time continuous glucose monitoring

Group 2- No group chat intervention

Experimental group

Description:

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

Treatment:

Behavioral: Real-time continuous glucose monitoring