Clinical trial NCT07009704: Glucose Empowerment Through Monitoring and Social Support in Pregnancy
Official title: Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy, Complications
Gestational Diabetes
Keywords: pregnancy
gestational diabetes
GDM
intervention
hyperglycemia
group chat
continuous glucose monitoring
mobile-based
behavioral change
CGM
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2025-06-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-efficacy for glucose management
timeFrame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study
Secondary outcomes:
measure: Motivation for glucose management
timeFrame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study
measure: Pregnancy-specific stress
timeFrame: Baseline, Day 60 of study participation
measure: Social support
timeFrame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 30 of group chat participation, Day 60 of study participation
measure: Pre-natal care satisfaction
timeFrame: Baseline, Day 60 of study completion
Other outcomes:
Locations:
Study officials:
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