70 Participants Needed

Glucose Monitoring + Social Support for Gestational Diabetes

(GEMS-P Trial)

LC
Overseen ByLarissa Calancie, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Tufts Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a continuous glucose monitor, which displays blood sugar levels in real time on a smartphone app, combined with a group chat for mobile-based social support, can maintain healthy blood sugar levels during pregnancy. Pregnant participants in one group will use both the monitor and the chat, while another group will use only the monitor. The trial aims to determine if these tools improve blood sugar management. It is suitable for pregnant individuals who have had gestational diabetes, have a family member with type II diabetes, or have a BMI over 25, and are planning to deliver at Tufts Medicine in Boston. As an unphased trial, this study provides a unique opportunity to explore innovative tools for managing blood sugar during pregnancy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have chronic illnesses that require regular medication, you may not be eligible to participate.

What prior data suggests that this method is safe for managing blood glucose levels during pregnancy?

Research has shown that using a mobile app for support and remote monitoring safely manages gestational diabetes. Studies have found that these apps effectively help individuals control their blood sugar levels. Many participants reported positive experiences and found the digital support useful.

For real-time continuous glucose monitoring (CGM), research indicates it is generally safe and well-tolerated during pregnancy. Studies show that CGM provides instant blood sugar information, aiding in better management of gestational diabetes. Participants using CGM maintained more stable blood sugar levels and experienced few, if any, serious side effects.

Overall, both methods appear well-tolerated, with minimal risk of negative effects reported in studies.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines real-time continuous glucose monitoring with mobile-based social support, offering a novel approach to managing gestational diabetes. Unlike traditional methods that mainly involve dietary changes and insulin therapy, this trial's approach uses technology to provide immediate feedback on glucose levels and emotional support through a group chat. This could lead to better glucose management and improved outcomes for mothers by fostering a community that encourages adherence to healthy behaviors.

What evidence suggests that this trial's treatments could be effective for managing blood glucose levels during pregnancy?

Research has shown that using a mobile health app with social support can help people with gestational diabetes manage their blood sugar more effectively. One study found that these tools encourage self-care, making it easier to handle the condition. Another review found that mobile health tools improved blood sugar control in pregnant individuals. In this trial, participants in Group 1 will use a mobile-based group chat for social support alongside real-time continuous glucose monitoring.

Real-time continuous glucose monitoring has also shown promise. Studies indicate that it helps maintain more stable blood sugar levels compared to older methods. This technology can improve both blood sugar control and overall pregnancy outcomes. Participants in both Group 1 and Group 2 of this trial will use real-time continuous glucose monitoring, with Group 2 not receiving the group chat intervention.34567

Are You a Good Fit for This Trial?

This trial is for pregnant individuals less than 20 weeks along, aged 18-45, with a BMI over 25 or a personal/family history of diabetes. They must be getting care at Tufts Medicine (Boston), comfortable in English, located in the US, own a smartphone and agree to use specific apps.

Inclusion Criteria

I am pregnant and less than 20 weeks along.
I am comfortable speaking in English.
I am getting prenatal care and plan to give birth at Tufts Medicine in Boston.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear a real-time continuous glucose monitor for 14 days. Group 1 also participates in a secure mobile-based group chat for 60 days.

8 weeks
Baseline, Day 3, Day 7, Day 14, Day 30, Day 60

Follow-up

Participants are monitored for self-efficacy, motivation, stress, social support, and prenatal care satisfaction.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mobile-based social support
  • Real-time continuous glucose monitoring
Trial Overview The study tests if using a real-time continuous glucose monitor linked to an app and participating in mobile-based group chats helps maintain healthy blood sugar levels during pregnancy.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Group 2- No group chat interventionExperimental Treatment1 Intervention
Group II: Group 1- Group chat interventionExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials
264
Recruited
264,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/41135300/
Effects of mobile health management model on the ...Outcomes included the incidence of gestational diabetes mellitus, oral glucose tolerance test values at 24 weeks of gestation, self-management ...
a 1-year, prospective, multicentre, randomised controlled trialPrimary outcome was achieved by 46.3% (56) of intervention participants compared to 43.3% (52) in the control group [odds ratio (OR) 1.13, 95% ...
The Effect of a Mobile App (eMOM) on Self-Discovery and ...Conclusions: The eMOM mobile app combining data from continuous glucose monitor, food diary, and physical activity tracker supports maternal ...
Effectiveness of mobile health interventions for pregnant ...The review included 27 studies with a total of 3483 patients. The results showed a significant improvement in glycemic control. In addition, ...
Effects of online support and social media communities on ...Online support interventions were found to have a positive impact on promoting self-care and improving healthcare outcomes for women with GDM.
Evaluating the efficacy and acceptability of a digital-based ...This study investigates the impact of a digital-based management system designed to support women with diabetes from pregnancy through the first year post ...
Impact of a novel smartphone application for remote ...This app-assisted model of care for GDM safely facilitates self-management and remote monitoring of GDM.
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