Pregnancy, ComplicationsGEMS-PNCT07009704
Glucose Empowerment Through Monitoring and Social Support in Pregnancy
A study testing Mobile-based social support and Real-time continuous glucose monitoring in people with Pregnancy, Complications and Gestational Diabetes, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Complications, Gestational Diabetes
- What is being tested?
- Mobile-based social support and Real-time continuous glucose monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Larissa Calancie
About this study
Official title: Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During 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.
- Conditions
- Pregnancy, Complications, Gestational Diabetes
- Being tested
- Mobile-based social support, Real-time continuous glucose monitoring
- Keywords
- pregnancy, gestational diabetes, GDM, intervention, hyperglycemia, group chat, continuous glucose monitoring, mobile-based, behavioral change, CGM
- Medical subject headings
- Pregnancy Complications, Diabetes, Gestational, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-based social supportBehavioural
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 monitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Group chat intervention | Experimental | 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. Receives: Behavioral: Mobile-based social support; Behavioral: Real-time continuous glucose monitoring |
| Group 2- No group chat intervention | Experimental | Participants in group 2 will be randomized to wear a real-time continuous glucose monitor for 14 days. Receives: Behavioral: Real-time continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy for glucose management
Self-efficacy will be adapted from a validated survey of self-efficacy for type II diabetes management (DMSES UK)
Measured: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study
Secondary outcomes (4)
Motivation for glucose management
Assessed using items from the Treatment Self-Regulation Questionnaire (TSRQ)
Measured: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study
Pregnancy-specific stress
Pregnancy-specific stress will be measured (via questionnaire) using a validated scale that was empirically associated with birth outcomes
Measured: Baseline, Day 60 of study participation
Social support
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)
Measured: 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
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".
Measured: Baseline, Day 60 of study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jul 2025
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009704
- Sponsor's protocol ID
- STUDY00005143
- Other IDs
- K12HD092535, K12AR084217
- Acronym
- GEMS-P
- Status last verified
- Sep 2025
- First submitted
- 7 Jan 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During Pregnancy
- ClinicalTrials.gov ID
- NCT07009704
- Acronym / sponsor ID
- GEMS-P / STUDY00005143
- Conditions
- Pregnancy, Complications, Gestational Diabetes
- Keywords
- pregnancy, gestational diabetes, GDM, intervention, hyperglycemia, group chat, continuous glucose monitoring, mobile-based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1- Group chat intervention | Experimental | Behavioral: Mobile-based social support, Behavioral: Real-time continuous glucose monitoringParticipants 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. |
| Group 2- No group chat intervention | Experimental | Behavioral: Real-time continuous glucose monitoringParticipants in group 2 will be randomized to wear a real-time continuous glucose monitor for 14 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile-based social supportParticipants 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. | Behavioural | Group 1- Group chat intervention |
| Real-time continuous glucose monitoringParticipants 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. | Behavioural | Group 1- Group chat intervention, Group 2- No group chat intervention |
Primary outcome
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)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pregnancy, Complications
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-based social support and Real-time continuous glucose monitoring in people with Pregnancy, Complications and Gestational Diabetes, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larissa Calancie, PhD ((617) 636-0976, larissa.calancie@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy for glucose management (time frame: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.