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NCT Number: NCT07009704

Glucose Empowerment Through Monitoring and Social Support in Pregnancy

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.

Recruiting

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Key information

Conditions

Pregnancy, Complications Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location status: Recruiting

Location contact

Larissa Calancie

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile-based social support

Behavioral

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

Behavioral

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 outcomes

  1. Self-efficacy for glucose management

    Time frame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study

    Self-efficacy will be adapted from a validated survey of self-efficacy for type II diabetes management (DMSES UK)

Secondary outcomes

  1. Motivation for glucose management

    Time frame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study

    Assessed using items from the Treatment Self-Regulation Questionnaire (TSRQ)

  2. Pregnancy-specific stress

    Time frame: Baseline, Day 60 of study participation

    Pregnancy-specific stress will be measured (via questionnaire) using a validated scale that was empirically associated with birth outcomes

  3. 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

    A social support survey was adapted from the validated Inventory of Socially Supportive Behaviors (ISSB) that assess multiple subtypes of social support (emotional, informational, instrumental/tangible, belonging, appraisal)

  4. Pre-natal care satisfaction

    Time frame: Baseline, Day 60 of study completion

    Prenatal care satisfaction will be assessed using a combination of questions from Raube and colleague's validated questionnaire and the Mother's Autonomy in Decision Making (MADM) scale. The combination of questionnaires is scored as "Excellent, Good, Average, Poor, N/A".

Study contacts

Contact information is provided by the study sponsor or research team.

Larissa Calancie, PhD

CONTACT

[email protected]

(617) 636-0976

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During Pregnancy

Acronym: GEMS-P

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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