50 Participants NeededMy employer runs this trial

Continuous Glucose Monitoring for Prediabetes

(G3 Trial)

DS
RF
Overseen ByRuth Flores
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: David S Black, PhD
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 a new method to help individuals with prediabetes (higher than normal blood sugar levels) avoid developing type 2 diabetes. Participants will wear a continuous glucose monitor (CGM) on their arm to track blood sugar levels. Initially, participants cannot see their glucose levels, but later, they will receive feedback through a smartphone app. Individuals aged 35 or older with prediabetes who are willing to wear a CGM sensor may be suitable for this study. The goal is to use this technology to enhance daily blood sugar control and prevent diabetes. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could prevent diabetes and improve health outcomes.

Do I need to stop my current medications for this trial?

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

What prior data suggests that continuous glucose monitoring is safe for prediabetes?

Research has shown that using a continuous glucose monitor (CGM) is generally safe for most people. Studies indicate that CGMs can greatly enhance the quality of life for individuals with diabetes by boosting their confidence in managing blood sugar levels. For those with prediabetes, CGMs might offer similar benefits by helping to track and control blood sugar before it reaches diabetic levels.

Regarding safety, many studies have found CGMs to be well-tolerated. Specifically, one study found a significant reduction in severe low blood sugar episodes (hypoglycemia) after participants began using CGMs. This finding suggests that CGMs are not only safe but may also help prevent dangerous drops in blood sugar.

Overall, CGMs have been successfully used by both individuals with diabetes and those without, showing promise in safely managing blood sugar levels.12345

Why are researchers excited about this trial?

Continuous Glucose Monitoring (CGM) is unique because it offers a proactive approach to managing prediabetes by providing real-time data on glucose levels. Unlike traditional methods like periodic blood tests or finger pricks, CGM continuously tracks glucose, allowing for more precise monitoring and potentially quicker lifestyle adjustments. Researchers are particularly excited about the trial's innovative approach, which includes a phase where participants can see their glucose data live. This real-time visibility can empower individuals to make immediate decisions about diet and activity, potentially preventing the progression to full-blown diabetes.

What evidence suggests that continuous glucose monitoring is effective for prediabetes?

Research has shown that Continuous Glucose Monitoring (CGM) can improve blood sugar control. Regular CGM users often experience a small but significant drop in hemoglobin A1c levels, a key measure of long-term blood sugar control. For instance, one study found a reduction of about 0.32% in these levels. Another study demonstrated significant improvements in A1c levels compared to those who do not use CGM. For individuals with prediabetes, this can lower the risk of developing type 2 diabetes. Overall, CGM use allows individuals to monitor their glucose levels more closely, potentially leading to better health outcomes.

In this trial, participants will wear a CGM device on the back of the arm. During Phase A, glucose values will remain hidden from participants, while in Phase B, glucose values will be visible via a phone app.23678

Who Is on the Research Team?

DS

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 adults aged 35 or older who have prediabetes, shown by blood tests or a doctor's diagnosis, and are willing to wear a continuous glucose monitor (CGM).

Inclusion Criteria

* Willingness to wear CGM sensor * Prediabetes by finger prick blood A1C% or fasting glucose
* Centers for Disease Control and Prevention (CDC) prediabetes risk test score of 5 or higher or recent prediabetes diagnosis from physician
I am 35 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Masked CGM Phase

Participants wear CGM devices with glucose data masked for 10 days

10 days
1 visit (in-person) for device setup

Unmasked CGM Phase

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

10 days
Daily virtual feedback via smartphone

Follow-up

Participants are monitored for safety and effectiveness after the intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Continuous Glucose Monitoring (CGM)

Trial Overview

The study is testing if using a wearable CGM device along with smartphone feedback and AI-generated educational videos can help people with prediabetes better control their blood sugar and prevent type 2 diabetes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single Group: CGM with Masked Phase A and Unmasked Phase BExperimental Treatment1 Intervention

Find a Clinic Near You

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

Continuous Glucose Monitoring for Prediabetes - PMC - NIH

National Health and Nutrition Examination Survey data also demonstrate a modest increase in peripheral neuropathy in prediabetes compared with normoglycemia.

Continuous Glucose Monitoring for Prediabetes

Continuous glucose monitoring (CGM) has transformed the care of patients with diabetes, and there is great potential to extend these benefits to prediabetes.

Continuous Glucose Monitoring (CGM) in Prediabetes

Specifically, the study primarily aims to determine the effectiveness of CGM in raising their diabetes literacy, adopting low carbohydrate and ...

Continuous Glucose Monitoring Frequency and Glycemic ...

Meaning This study found that continuous use of CGM (>75% of days) improves glycemic control compared with less frequent or no CGM, suggesting ...

Study Shows Promise Using Continuous Glucose ...

Individuals with prediabetes defined by current criteria can experience a 40 to 70 percent reduction in diabetes risk. However, this benefit is often not ...

Continuous Glucose Monitoring: A Transformative Approach ...

A study in type 1 diabetes (T1D) patients has shown that CGM use significantly enhances quality of life, boosting confidence in blood sugar ...

Efficacy and Safety of Continuous Glucose Monitoring and ...

Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

Advances in Continuous Glucose Monitoring: Clinical ... - PMC

Another study indicates that severe hypoglycemia incidence decreased from 14.6% to 7.8% after CGM adoption [19]. Effectiveness of CGM in ...