Continuous Glucose Monitoring for Prediabetes

(G1 Trial)

Overseen By Ruth Flores

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Pregnancy, Under 18, Glucose disorders, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

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 a smartphone app and AI-generated educational videos, can help individuals with prediabetes manage their blood sugar levels more effectively. By enhancing blood sugar control, the goal is to prevent the onset of type 2 diabetes. Ideal participants are Latino community health workers with prediabetes who are willing to wear a CGM sensor and possess a compatible smartphone. As an unphased trial, this study provides participants the chance to contribute to innovative research that could improve prediabetes management strategies.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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. Many studies have found that CGMs help individuals with both Type 1 and Type 2 diabetes manage their blood sugar levels effectively. Worn on the body, the device regularly checks blood sugar, simplifying health monitoring.

Most people tolerate CGM devices well, with no major reports of negative effects. The most common issue is minor skin irritation where the sensor attaches, but this is usually mild and resolves quickly.

Overall, CGMs are a reliable tool for managing diabetes and are considered safe based on current research. Users often find them helpful for understanding and controlling their blood sugar levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) for prediabetes because it offers real-time insights into blood sugar levels, which is a significant advancement over traditional methods like periodic fingerstick tests. Unlike standard care options that provide sporadic glucose readings, CGM gives continuous feedback, helping individuals better understand how their diet and lifestyle affect their blood sugar throughout the day. This continuous feedback loop empowers patients to make immediate and informed lifestyle adjustments, potentially preventing the progression to type 2 diabetes.

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

Research has shown that continuous glucose monitoring (CGM) helps people with diabetes maintain better blood sugar control. For individuals with type 2 diabetes, CGM can lower HbA1c, an important measure of blood sugar management. Users of CGM often report greater satisfaction with their diabetes management due to real-time updates provided by the device. Overall, CGM has effectively improved blood sugar control and might help prevent prediabetes from progressing to type 2 diabetes. Participants in this trial will use the CGM system to explore its potential benefits for managing prediabetes. ^{2 5 6 7 8}

Who Is on the Research Team?

David S Black, PhD MPH

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for individuals with prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be type 2 diabetes. Participants should be interested in using a wearable glucose monitoring device and engaging with smartphone feedback and educational videos.

Inclusion Criteria

Pre-diabetes by finger prick

Latino community health worker

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

Exclusion Criteria

Currently pregnant

I am under 18 years old.

I have a condition that affects my blood sugar levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants wear CGM devices for 20 days and record daily narratives about their experiences with CGM feedback and glucose variability

3 weeks

Daily self-monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitoring

Trial Overview The study tests whether wearing a continuous glucose monitor (CGM) combined with AI-generated smartphone feedback and video clips can help control blood sugar levels in people with prediabetes to prevent the onset of type 2 diabetes.

How Is the Trial Designed?

Group I: Unmasked CGM feedback Experimental Treatment 1 Intervention

The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.

Continuous Glucose Monitoring is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in European Union as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes
• Gestational diabetes

Approved in Canada as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Japan as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Continuous glucose monitoring (CGM) systems have been shown to significantly improve Hemoglobin A1c (HbA1c) levels and reduce glucose variability in type 1 diabetes patients, particularly when used with insulin delivery systems, as supported by randomized controlled trials.

Flash glucose monitoring systems, like FreeStyle® Libre™, are comparable in accuracy to CGM systems and are well-tolerated by patients, effectively reducing glucose variability and increasing the time spent within target glucose ranges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Use of Continuous Glucose Monitoring in Adults with Type 1 Diabetes. Slattery, D., Choudhary, P.[2022]

New 'flash' continuous glucose monitoring (CGM) technology is emerging as a more affordable and user-friendly option for diabetes management, potentially increasing its accessibility for patients.

This novel CGM approach aims to provide continuous data that can be used more routinely in primary care settings, enhancing daily diabetes management for a larger number of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Flash Continuous Glucose Monitoring in Primary Practice. Hirsch, IB., Wright, EE.[2021]

Flash continuous glucose monitoring (CGM) provides real-time glucose level information, helping individuals with diabetes prevent hypoglycemia and hyperglycemia, which is crucial for effective glycemic control.

Recent real-world studies have shown that flash CGM not only improves clinical outcomes for patients with type 1 and type 2 diabetes but also enhances healthcare resource utilization, indicating its practical benefits beyond controlled trial settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flash Continuous Glucose Monitoring: A Summary Review of Recent Real-World Evidence. Bailey, CJ., Gavin, JR.[2022]

The FreeStyle Libre flash glucose monitoring system (FGMS) was found to be easy to use and well tolerated by diabetic dogs, with only mild skin irritation observed in some cases.

The FGMS demonstrated high accuracy in measuring interstitial glucose levels, correlating well with plasma glucose concentrations, achieving 93% to 99% accuracy across different blood glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a Flash Glucose Monitoring System in Diabetic Dogs. Corradini, S., Pilosio, B., Dondi, F., et al.[2022]

Flash continuous glucose monitoring (CGM) offers an affordable and user-friendly option for patients, allowing them to scan a sensor for real-time glucose data, which can help in adjusting therapy and understanding glucose patterns.

Increased scanning frequency with flash CGM is linked to better glycemic control, showing more time spent in the target glucose range and less time in hyperglycemia and hypoglycemia, highlighting its potential benefits for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flash Continuous Glucose Monitoring: Implications for Use of Continuous Data in Daily Diabetes Management. Hirsch, IB., Nardacci, E., Verderese, CA.[2020]

The FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system showed that 85.5% of its readings from the arm fell within the clinically acceptable range when compared to a standard blood glucose measurement, indicating good efficacy for monitoring glucose levels in patients with diabetes.

However, the FSL-CGM system tended to underestimate glucose levels at lower ranges and overestimate them at higher ranges, particularly after meals, suggesting that users should be cautious and follow optimized instructions for accurate daily management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. Fokkert, MJ., van Dijk, PR., Edens, MA., et al.[2022]

Continuous glucose monitoring (CGM) systems are safe and accurate for managing glucose levels in hospitalized patients, providing real-time data that helps healthcare professionals make timely decisions.

CGM can significantly reduce both hypoglycemia and hyperglycemia in patients with diabetes, while also minimizing the need for frequent blood tests and reducing staff exposure to infection, which is particularly important during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in the hospital: an update in the era of COVID-19. Gothong, C., Singh, LG., Satyarengga, M., et al.[2021]

In a study of 64 youth with type 1 diabetes, those using flash glucose monitoring (FGM) reported a higher incidence of cutaneous adverse events (AEs) compared to those using self-monitored blood glucose (SMBG), with 58% of FGM users experiencing AEs versus 23% in the control group.

Most cutaneous AEs associated with FGM were mild, with 80% rated as mild, and despite these AEs, the majority of participants continued using FGM, indicating its overall acceptance and potential benefits despite some skin-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus. Marsters, BL., Boucher, SE., Galland, BC., et al.[2022]

The FreeStyle Libre® flash glucose monitoring system effectively measures glucose levels and trends, helping individuals with diabetes prevent dangerous highs and lows in blood sugar.

Proper use of the device can significantly enhance glycemic control and improve the quality of life for users, making it essential to understand how to interpret glucose data and trends effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Approach to Flash Glucose Monitoring: An Expert Recommendation. Chico, A., Aguilera, E., Ampudia-Blasco, FJ., et al.[2021]

In a 24-week study of 36 patients with type 1 diabetes using continuous insulin infusion, those using the Flash glucose monitoring system showed a significant improvement in hemoglobin A1c (HbA1c) levels, decreasing from 7.8% to 7.1%.

The Flash system led to a three-fold increase in daily glucose monitoring frequency compared to traditional self-monitoring, with no reported safety issues, suggesting it is a safe and effective tool for better blood glucose control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical value of Flash glucose monitoring in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion. Moreno-Fernandez, J., Pazos-Couselo, M., González-Rodriguez, M., et al.[2022]

The FreeStyle Libre™ Flash Glucose Monitoring System (Flash GM) led to a significant reduction in HbA1c levels by an average of 0.41% in individuals with type 1 diabetes over a follow-up period of 2 to 24 months, based on a meta-analysis of 34 studies involving 5,466 participants.

This reduction in HbA1c was consistent even when excluding data from controlled trials, indicating that Flash GM can effectively lower blood sugar levels in diverse populations, although the variability in study designs suggests that results may differ in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of average change in laboratory-measured HbA1c among people with type 1 diabetes mellitus using the 14 day Flash Glucose Monitoring System. Gordon, I., Rutherford, C., Makarounas-Kirchmann, K., et al.[2022]

The FLASH education program significantly reduced HbA1c levels by 0.17% compared to the control group after six months, indicating improved glycaemic control for participants using flash sensor-based glucose monitoring (FSGM).

Participants in the FLASH program also experienced less diabetes-related distress and improved satisfaction with their glucose monitoring, while spending more time in the target glucose range and reducing the need for traditional fingerstick blood glucose testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Hermanns, N., Ehrmann, D., Schipfer, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460137/

The Effectiveness of Continuous Glucose Monitoring ... CGM demonstrated improved outcomes in T1DM with lower HbA1c and reduced severe hypoglycemia, while in T2DM, CGM significantly lowered HbA1c ...

2. 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.

3. e-enm.org e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ... Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

4. diabetesjournals.org diabetesjournals.org/care/article/48/10/1794/163119/Continuous-Glucose-Monitoring-Metrics-Predict-All

Continuous Glucose Monitoring Metrics Predict All-Cause ... Clinical trials and real-world studies have demonstrated that initiating continuous glucose monitoring (CGM) improves glycemic control, reduces ...

5. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.10-b.s30

Using continuous glucose monitoring to measure and ... The Glucose Management Indicator can be used as a measure of glucose control. This article discusses the benefits of value-based care, the importance of ...

6. niddk.nih.gov niddk.nih.gov/health-information/diabetes/overview/managing-diabetes/continuous-glucose-monitoring

Continuous Glucose Monitoring - NIDDK Continuous glucose monitoring means using a device to automatically estimate your blood glucose level, also called blood sugar, throughout the day and night.

7. diabetesjournals.org diabetesjournals.org/clinical/article/42/3/398/154390/Detection-and-Intervention-Use-of-Continuous

Detection and Intervention: Use of Continuous Glucose ... Numerous studies have demonstrated the safety and efficacy of continuous glucose monitoring (CGM) in individuals with type 1 diabetes and those ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/articles/continuous-glucose-monitoring-cgm

Continuous Glucose Monitoring (CGM): What It Is A continuous glucose monitor (CGM) is a wearable device that tracks your glucose (sugar) levels in real time. It's a tool people with diabetes use.