Real-time glucose monitoring with group support during pregnancy
Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During Pregnancy
This program will test whether wearing a real-time glucose monitor and joining a group chat helps pregnant people at risk for gestational diabetes keep their blood sugar in a healthy range.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Tufts Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07009704 on ClinicalTrials.gov |
What this trial studies
Participants early in pregnancy (<20 weeks) wear a continuous glucose monitor that streams real-time glucose levels to a smartphone app and join a mobile group chat for peer support. The intervention combines immediate glucose feedback with social messaging to prompt short-term actions (for example, walking or drinking water) and to share dietary and self-care tips. Investigators will track glucose patterns, engagement with the app and chat, and pregnancy outcomes to see if the combined approach helps maintain healthier blood glucose. The program is delivered via participants' own smartphones and run through Tufts Medical Center with follow-up through delivery.
Who should consider this trial
Good fit: Pregnant people under 20 weeks' gestation, aged 18–45, with BMI >25 or a personal or first-degree family history of type 2 diabetes who own a smartphone, are comfortable in English, and plan prenatal care and delivery at Tufts Medical Center.
Not a fit: Those with preexisting diabetes, multiple gestation pregnancies, certain active infections or substance use, prior gastric bypass, chronic illnesses requiring regular medication or dialysis, shift work that alters sleep, or those not planning to deliver at Tufts or without a smartphone are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could help lower high blood sugar during pregnancy and reduce the risk of complications for both parent and baby.
How similar studies have performed: Continuous glucose monitoring has improved glucose detection and control in pregnancy in prior work, but pairing real-time CGM with a structured peer group chat is a relatively novel combination.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Larissa Calancie, PhD
- Email: larissa.calancie@tufts.edu
- Phone: (617) 636-0976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.