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

21 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this project is to develop a behavioral intervention that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and educational video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with pre-diabetes. The goal is to prevent transition to type 2 diabetes.

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 data supports the idea that Continuous Glucose Monitoring for Prediabetes is an effective treatment?

The available research shows that Continuous Glucose Monitoring (CGM), particularly the flash type, is effective in managing diabetes by providing immediate information about glucose levels. This allows users to make quick adjustments to prevent high or low blood sugar levels. Studies have shown that using CGM can increase the time people spend with their blood sugar in the target range and reduce the time spent in dangerous high or low ranges. Although the research primarily focuses on diabetes, these benefits suggest that CGM could also be effective for prediabetes by helping individuals monitor and manage their glucose levels more effectively compared to traditional methods. ^{1 2 3 4 5}

What safety data exists for continuous glucose monitoring?

The research indicates that there is limited literature on cutaneous adverse events associated with flash glucose monitoring, particularly among youth with type 1 diabetes. This suggests that while the technology is becoming more user-friendly and affordable, there may still be some safety concerns, particularly related to skin reactions. ^{3 4 6 7 8}

Is Continuous Glucose Monitoring a promising treatment for prediabetes?

Yes, Continuous Glucose Monitoring (CGM) is promising because it helps people track their blood sugar levels easily and in real-time. This can prevent dangerous highs and lows in blood sugar, improve overall blood sugar control, and enhance quality of life. It also allows users to adjust their lifestyle and treatment based on their glucose patterns, making it a valuable tool for managing prediabetes. ^{3 9 10 11 12}

Research Team

David S Black, PhD MPH

Principal Investigator

University of Southern California

Eligibility Criteria

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

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

Latino community health worker

Exclusion Criteria

Currently pregnant

Influential medical disorder/event affecting ability to participate in study

I am under 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Flash Continuous Glucose Monitoring: A Summary Review of Recent Real-World Evidence. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Use of Continuous Glucose Monitoring in Adults with Type 1 Diabetes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Flash Continuous Glucose Monitoring: Implications for Use of Continuous Data in Daily Diabetes Management. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Using Flash Continuous Glucose Monitoring in Primary Practice. [2021]

5. Ireland 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in the hospital: an update in the era of COVID-19. [2021]

8. Denmark pubmed.ncbi.nlm.nih.gov

Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical Approach to Flash Glucose Monitoring: An Expert Recommendation. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Accuracy of a Flash Glucose Monitoring System in Diabetic Dogs. [2022]

11. Spain pubmed.ncbi.nlm.nih.gov

Clinical value of Flash glucose monitoring in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion. [2022]

12. Ireland 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. [2022]