Glucose Empowerment Through Monitoring and Social Support in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile-based social support, Real-time continuous glucose monitoring.
- Who it may be relevant to
- Registry conditions: Pregnancy, Complications, Gestational Diabetes. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During Pregnancy
Overview
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.
Interventions
- Behavioral 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. - Behavioral 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 measures
- Self-efficacy for glucose management [Time frame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study]
Secondary outcome measures (4)
- Motivation for glucose management [Time frame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study]
- Pregnancy-specific stress [Time frame: Baseline, Day 60 of study participation]
- Social support [Time frame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 30 of group chat participation, Day 60 of study participation]
- Pre-natal care satisfaction [Time frame: Baseline, Day 60 of study completion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Tufts Medical Center — Boston
Identifiers
NCT: NCT07009704 · STUDY00005143 · K12HD092535 · K12AR084217