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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how environmental stress affects blood sugar levels and whether continuous glucose monitoring (CGM) can help prevent diabetes. The researchers aim to create educational interventions, both in person and via video, to promote diabetes prevention in the Hispanic community. Participants should identify as Hispanic and have a parent with type 2 diabetes to be eligible. This research could also influence policies related to health factors in the community. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could benefit the health of the Hispanic community.

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 prior data suggests that this intervention is safe for diabetes prevention?

Research has shown that using videos to educate people about diabetes is generally well-received. Several studies have found that watching these videos can lead to a noticeable drop in HbA1C levels, a measure of average blood sugar over time. These reductions ranged from 0.1% to 2.1%, indicating that video education can effectively manage and prevent diabetes.

This method presents no major safety concerns. Video education is a low-risk way to enhance understanding of the condition without causing harm. Participants can confidently use video education as a tool to prevent diabetes. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to prevent diabetes through continuous glucose monitoring and tailored education. Unlike traditional methods, which often involve standard in-person sessions, this trial includes virtual and video-based education that can be more accessible and convenient for participants. This approach not only aims to make education more flexible but also personalizes feedback by using real-time glucose data, potentially leading to better prevention strategies. By integrating technology with health education, the trial could pave the way for more effective diabetes prevention techniques.

What evidence suggests that this trial's treatments could be effective for diabetes prevention?

This trial will compare in-person or virtual diabetes education with video-based education. Research has shown that educational videos can help manage diabetes by lowering HbA1C levels, an important measure of blood sugar. Studies have found that these videos can reduce HbA1C by up to 2.1%. This suggests video education might benefit people at risk of diabetes. Additionally, telemedicine, which includes video education, has lowered the risk of developing type 2 diabetes in overweight individuals. These findings suggest that video-based education could be useful in preventing diabetes. ^{3 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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]

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]

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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37690072/

The use of videos for diabetes patient education A statistically significant decrease (ranging from -0.1% to -2.1%) in HbA1C was noted in 7 of 12 studies examining this outcome. Other studies ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1871402125000694

a systematic review and meta-analysis of interventions Our study demonstrates effectiveness for telemedicine-delivered interventions in preventing T2D in people at risk, specifically in people with overweight/ ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/dmrr.3722

The use of videos for diabetes patient education: A ... A statistically significant decrease (ranging from −0.1% to −2.1%) in HbA1C was noted in 7 of 12 studies examining this outcome. Other studies ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07107789?cond=diabetes

The Effect of Diabetes Education Given With Video ... Research has shown that games and video animations are effective methods beyond medication. No studies have been found in the literature evaluating the effects ...

5. cdc.gov cdc.gov/diabetes/diabetes-tv/diabetes-kickstart.html

Diabetes Kickstart Video Series Diabetes education saves you time, saves you money, and enhances your quality of life. These seven animated videos will show you the self-care ...

6. youtube.com youtube.com/watch?v=s_C-H4RaXIU

NHS Diabetes Prevention Programme; Preventing Type 2 ... The NHS and its partners are working towards preventing type 2 diabetes in those groups at risk as well as helping to keep those with both forms of diabetes healthy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10921551/

A Tool to Improve Engagement in Hard-to-Reach Populations This article presents a new free video series available to all that may help improve engagement with diabetes prevention programming in and out of the office ...