Continuous Glucose Monitoring for Diabetes Prevention

Overseen By Alexandra Garcia, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Pregnant, Type 1 diabetes

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment 'In person or virtual diabetes education, Video Diabetes Education' for diabetes prevention?

Research shows that continuous glucose monitoring (CGM) combined with education, whether in-person or virtual, can improve diabetes management. Studies indicate that CGM use, supported by education, leads to better blood sugar control and quality of life, suggesting that similar educational approaches could help in diabetes prevention. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Continuous glucose monitors (CGMs) have been associated with a significant number of adverse events, with 281,963 reported in 2022. This suggests that while CGMs are widely used, they can have safety issues that need to be considered. ^{1 6 7 8 9}

How does the treatment of in-person or virtual diabetes education with video diabetes education differ from other treatments for diabetes prevention?

This treatment is unique because it combines continuous glucose monitoring (CGM) with educational components, either in-person, virtual, or through video, to help individuals understand and manage their glucose levels more effectively. Unlike traditional methods that rely on periodic finger-stick tests, CGM provides real-time data, allowing for more comprehensive monitoring and personalized education to prevent diabetes. ^{10 11 12 13 14}

What is the purpose of this trial?

The purpose of the study is twofold: to see the impact of your environmental stress on daily glucose changes and to create an intervention using CGM to potentially decrease risk for diabetes. The aim of this study to develop an intervention to prevent diabetes in the Hispanic community and inform policies about social determinants of health.

Eligibility Criteria

This trial is for Hispanic adults at risk of developing diabetes. Participants should be interested in monitoring their glucose levels and willing to engage with either video or in-person/virtual diabetes education.

Inclusion Criteria

Self-identify as Hispanic

My parent has been diagnosed with type 2 diabetes.

Exclusion Criteria

I have Type 1 diabetes.

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo an oral glucose tolerance test (oGTT) to evaluate glucose intolerance or prediabetes

1 week

1 visit (in-person)

Intervention

Participants receive education and feedback based on their CGM results, either in person or via videos

4 weeks

2 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in diabetes knowledge and glucose variability

4 weeks

Treatment Details

Interventions

• In person or virtual diabetes education
• Video Diabetes Education

Trial Overview The study aims to observe how environmental stress affects daily glucose fluctuations and test an intervention using Continuous Glucose Monitors (CGM) to reduce diabetes risk among Hispanics.

Participant Groups

Group I: Video Intervention Experimental Treatment 1 Intervention

Patients will receive a link to a video of a nurse explaining their results.

Group II: In Person patient education Active Control 1 Intervention

Participants will receive patient education in person or virtually. They will get the results from their tests

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Findings from Research

The IDEAL CGM web-based training intervention showed proof of concept for improving adherence to continuous glucose monitors (CGM) among adolescents and young adults with type 1 diabetes, although engagement levels varied significantly among participants.

While the study indicated potential benefits for glycemic control and psychosocial measures, it highlighted the need for revisions to enhance participant engagement and ensure effective training before conducting larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study. Smith, MB., Albanese-O'Neill, A., Yao, Y., et al.[2021]

Users of continuous glucose monitors (CGMs) reported significantly greater benefits and fewer burdens compared to nonusers, with mean scores indicating higher satisfaction (4.48 vs. 4.19 for benefits) and lower perceived burdens (1.69 vs. 2.35) among CGM users.

CGM users had better glycemic control, as indicated by lower average HbA1c levels (8.1% for users vs. 9.1% for nonusers), highlighting the efficacy of CGMs in managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Burdens and Benefits Associated With Continuous Glucose Monitor Use in Type 1 Diabetes Across the Lifespan. Divan, V., Greenfield, M., Morley, CP., et al.[2022]

Continuous glucose monitors (CGMs) and insulin pumps are effective tools for managing type 1 diabetes (T1D), but access to these technologies is significantly limited for marginalized and economically disadvantaged groups.

Barriers to accessing diabetes technology include financial constraints, provider biases, and lack of support, highlighting the need for comprehensive strategies to improve awareness and healthcare policies to ensure equitable access and better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing disparities in technology use among patients with type 1 diabetes: a review. Kanbour, S., Everett, E.[2023]

Regularly reviewing weekly continuous glucose monitoring (CGM) reports is linked to improved quality of life (QoL) and glycemic outcomes in adults with diabetes, with 73.1% reporting better A1C levels and 75.9% feeling more confident about managing hypoglycemia.

Engaging with the report, especially by discussing it with family or friends, positively impacts QoL and perceived glycemic control, while doing nothing with the report's information is associated with poorer glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Retrospective Data Review in the Personal Use of Real-Time Continuous Glucose Monitoring: Perceived Impact on Quality of Life and Health Outcomes. Polonsky, WH., Soriano, EC., Fortmann, AL.[2022]

A telehealth approach to initiating continuous glucose monitoring (CGM) was successful, with all 34 participants using CGM at 12 weeks and 94% using it at least 6 days per week, indicating high feasibility and sustained use.

Participants experienced significant improvements in glycemic control, with mean HbA1c decreasing from 8.3 to 7.2 and time in the target glucose range increasing by approximately 2.7 hours per day, alongside enhanced quality of life and reduced diabetes distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring. Gal, RL., Cohen, NJ., Kruger, D., et al.[2020]

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

In a study of 453 current continuous glucose monitoring (CGM) users, those who received CGM-specific education were significantly more likely to utilize low-glucose alerts and alarms, with odds ratios indicating a strong association (e.g., OR = 5.43 for low-glucose alerts).

Participants with CGM education were also more responsive to alerts, suggesting that such education can enhance glucose management and potentially improve diabetes care in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More Frequent Use of Glucose Alarms Is Associated with Continuous Glucose Monitoring-Specific Diabetes Education: Findings from the Dia·Link Diabetes Panel. Ehrmann, D., Priesterroth, LS., Olesen, B., et al.[2023]

A symposium with 20 diabetes educators highlighted various concerns regarding the implementation of continuous glucose monitoring (CGM), including patient acceptance, professional practice implications, and data privacy issues.

The discussions emphasized the importance of preparing diabetes educators to address these challenges proactively, ensuring they can help shape policies and standards as CGM technology becomes more widely available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues for the coming age of continuous glucose monitoring. Pichert, JW., Campbell, K., Cox, DJ., et al.[2018]

The study developed and validated two questionnaires, BenCGM and BurCGM, to assess the perceived benefits and burdens of continuous glucose monitors (CGM) among 431 adolescents with type 1 diabetes, revealing that those who see more benefits from CGM experience lower diabetes distress and higher self-efficacy.

The findings suggest that understanding adolescents' perceptions of CGM can help create targeted interventions to increase CGM usage, potentially leading to better diabetes management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CGM Benefits and Burdens: Two Brief Measures of Continuous Glucose Monitoring. Messer, LH., Cook, PF., Tanenbaum, ML., et al.[2020]

Continuous glucose monitoring provides a convenient alternative for diabetes patients to track their glucose levels regularly, eliminating the need for frequent finger-prick tests.

This technology simplifies the management of diabetes by reducing the number of supplies required for glucose monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring: A Review of Available Systems. Funtanilla, VD., Candidate, P., Caliendo, T., et al.[2020]

Continuous glucose monitoring (CGM) technology offers a more comprehensive view of a patient's glucose levels compared to traditional methods, which only provide a snapshot of current blood glucose.

Diabetes educators will be essential in integrating CGM into clinical practice, helping patients understand and manage their glycemic status more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring has left the station: are you onboard? Valentine, V.[2007]

In a study of 41 youth with type 2 diabetes, a 10-day continuous glucose monitoring (CGM) trial did not significantly improve glycemic control, as measured by time in range (TIR) and HbA1c levels, after 3-6 months.

Despite the lack of measurable improvements in glycemic control, most participants reported positive behavioral changes in diabetes management and expressed a desire to continue using CGM, suggesting potential benefits in self-management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term use of CGM in youth onset type 2 diabetes is associated with behavioral modifications. Manfredo, J., Lin, T., Gupta, R., et al.[2023]

Continuous glucose monitoring systems provide real-time glucose readings from interstitial fluid, significantly improving diabetes management for both type 1 and type 2 diabetes patients.

These systems help patients and healthcare providers analyze glucose patterns, leading to better glycemic control, reduced hemoglobin A1c levels, and fewer instances of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring for the Internist. Lee, GS., Lupsa, BC.[2022]

Continuous glucose monitors (CGMs) have been shown to significantly improve metabolic control and reduce hypoglycemia in adults with diabetes, based on large clinical trials.

Data supporting the benefits of CGMs in children and adolescents is less robust, indicating a need for further research, especially regarding insulin dosing algorithms and their effectiveness in younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in type 1 diabetes. Mauras, N., Fox, L., Englert, K., et al.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study. [2021]

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

Perceived Burdens and Benefits Associated With Continuous Glucose Monitor Use in Type 1 Diabetes Across the Lifespan. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Addressing disparities in technology use among patients with type 1 diabetes: a review. [2023]

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

The Role of Retrospective Data Review in the Personal Use of Real-Time Continuous Glucose Monitoring: Perceived Impact on Quality of Life and Health Outcomes. [2022]

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

Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring. [2020]

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

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]

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

More Frequent Use of Glucose Alarms Is Associated with Continuous Glucose Monitoring-Specific Diabetes Education: Findings from the Dia·Link Diabetes Panel. [2023]

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

Issues for the coming age of continuous glucose monitoring. [2018]

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

CGM Benefits and Burdens: Two Brief Measures of Continuous Glucose Monitoring. [2020]

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

Continuous Glucose Monitoring: A Review of Available Systems. [2020]

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

Continuous glucose monitoring has left the station: are you onboard? [2007]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Short-term use of CGM in youth onset type 2 diabetes is associated with behavioral modifications. [2023]

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

Continuous Glucose Monitoring for the Internist. [2022]

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

Continuous glucose monitoring in type 1 diabetes. [2021]