Continuous Glucose Monitoring for Prediabetes

(G2 Trial)

Overseen By Ruth Flores

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: David S Black, PhD

Disqualifiers: Pregnancy, Blood glucose disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a continuous glucose monitor (CGM) combined with health education videos can help individuals with prediabetes prevent the onset of type 2 diabetes. Participants will wear a small device to track blood sugar levels and receive video guidance to improve health habits. The study seeks individuals aware of their prediabetes and willing to use a CGM sensor. By enhancing blood sugar management, the trial seeks to prevent prediabetes from progressing into more serious health issues. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could help prevent diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that continuous glucose monitoring with health education videos is safe for individuals with prediabetes?

Research shows that continuous glucose monitors (CGMs) are generally easy to use. These devices provide real-time updates on blood sugar levels and are widely used. Studies have not found any major side effects directly linked to CGMs. They are approved for managing diabetes, indicating their safety.

Using CGMs with health education videos is a newer approach that builds on this safe technology. These videos aim to help people better understand and manage their blood sugar levels. No specific safety issues have been reported with the video component. Overall, evidence suggests that using CGMs, especially with educational videos, is safe for people with prediabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Continuous Glucose Monitoring (CGM) with Health Education Videos for prediabetes because it offers a proactive approach to managing blood sugar levels. Unlike traditional methods like lifestyle changes and periodic blood tests, CGM provides real-time feedback, allowing individuals to see how their diet and activities immediately affect their glucose levels. This immediate feedback, paired with educational videos, can empower people to make informed decisions about their health, potentially preventing the progression to type 2 diabetes.

What evidence suggests that continuous glucose monitoring with health education videos is effective for prediabetes?

Research has shown that continuous glucose monitoring (CGM) combined with health education videos can help people with prediabetes manage their blood sugar levels. Studies have found that this combination improves blood sugar control by keeping levels steady. This method might also prevent type 2 diabetes. The technology involves wearing a device that tracks blood sugar and sends feedback to a smartphone, providing real-time information to support healthier lifestyle choices. Overall, early evidence suggests that CGM with health education videos offers a promising approach to managing prediabetes. ^{1 2 3 6 7}

Who Is on the Research Team?

David S Black, PhD MPH

Principal Investigator

University of Southern California Keck School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with prediabetes, as indicated by a finger prick A1c% test. Participants must be willing to wear a continuous glucose monitoring (CGM) sensor and have a compatible smartphone device. Pregnant individuals or those with disorders affecting blood glucose levels or significant medical conditions that could impact participation are excluded.

Inclusion Criteria

Pre-diabetes determined by finger prick A1c%

Community health worker

I am willing to wear a continuous glucose monitor (CGM) sensor.

Exclusion Criteria

Influential medical disorder or event affecting ability to participate in the study

Incompatible smartphone device not pairing with the Dexcom CGM system

Currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Masked CGM Phase

Participants wear continuous glucose monitoring devices with data masked for 10 days

10 days

1 visit (in-person) for device setup

Unmasked CGM Phase

Participants wear continuous glucose monitoring devices with data unmasked and receive daily health education videos

10 days

Daily virtual interactions via smartphone

Follow-up

Participants are monitored for safety and effectiveness after the CGM phases

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitoring with Health Education Videos

Trial Overview The study tests the effectiveness of health education videos combined with wearable CGM feedback in improving glycemic control among prediabetic individuals. The aim is to use AI-generated video content to help prevent the onset of type 2 diabetes and related metabolic complications.

Who Is Running the Clinical Trial?

David S Black, PhD

Lead Sponsor

Trials

1

Recruited

30+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. trialx.com trialx.com/clinical-trials/listings/315641/continuous-glucose-monitoring-in-prediabetes-with-health-education-videos/

Continuous Glucose Monitoring in Prediabetes with Health ... The objective of this project is to deliver a behavior health education video series that combines wearable continuous glucose monitoring (CGM) with smartphone ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06472297

Continuous Glucose Monitoring in Prediabetes The objective of this project is to develop a behavioral intervention that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12146165/

Continuous glucose monitoring combined with artificial ... This article systematically explores the potential applications of continuous glucose monitoring (CGM) technology combined with artificial intelligence (AI) in ...

4. app.trialscreen.org app.trialscreen.org/trials/continuous-glucose-monitoring-prediabetes-health-education-videos-trial-nct06883812

Prediabetes Glucose Monitoring with Video Education Participation in this study may help improve glycemic control and prevent the development of type 2 diabetes. Participants will receive continuous glucose ...

5. dovepress.com dovepress.com/effectiveness-of-an-individualized-diabetes-health-education-program-u-peer-reviewed-fulltext-article-DMSO

Effectiveness of an individualized diabetes health ... Conclusion: Our findings suggest that incorporating RT-CGM into diabetes health education program can enhance glycemic control in prediabetic ...

6. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) CGMs continually monitor your blood glucose (blood sugar), giving you real-time updates through a device that is attached to your body.

7. youtube.com youtube.com/watch?v=iixyUku8C-k

Continuous Glucose Monitors (CGMs) & Over-the-Counter ... A continuous glucose monitor is a device that measures your blood sugar continuously.