CGM Academy for Type 1 Diabetes

Overseen By Natalia Garban

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Medical adhesive allergies

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

Compensation: Varies

Number of Visits: 8

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new virtual education program, the CGM Academy, can help young people with type 1 diabetes manage their blood sugar levels more effectively than the usual education. The study will also examine how this education impacts their diabetes-related stress, family involvement, and time spent learning about diabetes. Participants will either try the new program, which includes interactive workbooks and online sessions, or continue with the standard education. The trial seeks kids and teens aged 8–18 who have had type 1 diabetes for at least six months and use a continuous glucose monitor (CGM). As an unphased trial, this study offers a unique opportunity to contribute to innovative educational approaches for managing type 1 diabetes.

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

The protocol does not specify whether you need to stop taking your current medications. However, since the trial focuses on education and monitoring, it's likely you can continue your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education and monitoring rather than changing medication.

What prior data suggests that this virtual education curriculum is safe for youth with type 1 diabetes?

Research shows that continuous glucose monitoring (CGM) is a well-accepted tool that helps many people with type 1 diabetes manage their condition. Studies have found that CGM can improve blood sugar control by lowering HbA1c levels, an important measure of blood sugar over time. In recent years, more people have started using this technology.

CGM is generally safe to use. Some users might experience minor issues like skin irritation from the device, but serious side effects are rare. The CGM Academy program aims to help people understand and use CGM devices better through education, which is safe and can help participants manage their diabetes more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CGM Academy for Type 1 Diabetes because it offers a more interactive and engaging approach to diabetes management. Unlike standard education, this program provides an interactive workbook with problem-based learning and video links, allowing participants to learn in a dynamic way. Additionally, the inclusion of in-depth online group sessions with specialists helps tailor the learning experience, potentially leading to better understanding and management of glucose levels. This method aims to empower patients with knowledge and strategies that traditional approaches might not fully provide.

What evidence suggests that the CGM Academy is effective for managing type 1 diabetes?

Studies have shown that continuous glucose monitoring (CGM) helps children with type 1 diabetes manage their blood sugar more effectively. Research indicates that CGM lowers average blood sugar levels, reduces significant fluctuations, and maintains blood sugar within a healthy range for longer periods. One study found that children using CGM achieved better blood sugar control than those using traditional methods. Additionally, many users have provided positive feedback about CGM, indicating its potential as an effective diabetes management tool. This trial will compare the CGM Academy, which includes targeted education, with standard diabetes education. These findings suggest that CGM, combined with targeted education like the CGM Academy, could help young people with type 1 diabetes manage their blood sugar more effectively. ^{6 7 8 9 10}

Who Is on the Research Team?

Rebecca Barber, PhD, RN

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for young people aged 8-18 with Type 1 Diabetes who've had it for at least 6 months. They must be able to use a smartphone compatible with Dexcom G6 and G7 CGM devices, and participate in virtual visits. They should also speak English or Spanish.

Inclusion Criteria

I have a smartphone that works with the Dexcom G6 and G7 apps.

I have had Type 1 Diabetes for at least 6 months.

I can speak, read, and write in English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive an interactive workbook and participate in four online group sessions with diabetes care specialists

6 months

4 online group sessions

Standard Education

Participants receive standard education provided to all patients at CHLA

6 months

Follow-up

Participants are monitored for changes in glycemic outcomes, diabetes distress, and family responsibility

6 months

Questionnaires at baseline, week 4, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• CGM Academy

Trial Overview The study tests if a special online education program helps youth manage their blood sugar better than standard education. It includes an interactive workbook, video links, and group sessions with diabetes experts versus the usual patient education.

How Is the Trial Designed?

Group I: CGM Academy Experimental Treatment 1 Intervention

* receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies. * participate in four in-depth online group sessions with diabetes care and education specialists * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

Group II: Standard Diabetes Education Active Control 1 Intervention

* receive standard education provided to all patients at CHLA * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

The Enlite continuous glucose monitoring (CGM) sensor system is a comfortable and user-friendly device that can significantly aid diabetes educators in teaching children and adolescents about managing their glycemic control.

Improvements in the sensor's design have enhanced comfort during insertion and wear, which may lead to better adherence to using the device and ultimately improve its effectiveness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with the Enlite sensor in a multicenter pediatric study. Evans, K., Richardson, C., Landry, A., et al.[2022]

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]

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]

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]

An educational intervention on using trend arrows from real-time continuous glucose monitoring (rt-CGM) significantly improved glycemic control in adolescents with type 1 diabetes, leading to a reduction in time above range (TAR) and an increase in time in range (TIR).

The training also resulted in a significant decrease in total daily insulin dose (TDD), indicating that proper education on rt-CGM can enhance diabetes management and reduce insulin requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Approach to Using Trend Arrows on Real-Time Continuous Glucose Monitoring System in Type 1 Diabetes Adolescents Living Camp Setting Treated With Multiple Daily Injection or Continuous Subcutaneous Insulin Infusion Insulin Therapy. Bassi, M., Minuto, N., Fichera, G., et al.[2022]

The educational program for real-time continuous glucose monitoring (CGM) was developed through observational research and input from diabetes educators, endocrinologists, and patients, ensuring it meets the needs of those managing diabetes with medications or insulin pumps.

The program emphasizes a structured approach, starting with a group class that educates patients about CGM technology, which helps them make informed decisions about their readiness to use CGM and sets realistic expectations for its benefits and limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring technology for personal use: an educational program that educates and supports the patient. Evert, A., Trence, D., Catton, S., 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]

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]

A structured education program using continuous glucose monitoring (CGM) significantly improved diabetes management in children and young people, leading to a reduction in time below range (TBR) from 10.4% to 2.1% and an increase in time in range (TIR) from 47.4% to 57.0% over six months.

The program also resulted in a decrease in severe hypoglycemic episodes from 10 to 1 and a reduction in HbA1c levels from 7.4% to 7.1%, demonstrating its effectiveness in enhancing safety and glycemic control for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DYNAMIC: Dynamic glucose management strategies delivered through a structured education program improves time in range in a socioeconomically deprived cohort of children and young people with type 1 diabetes with a history of hypoglycemia. Pemberton, JS., Kershaw, M., Dias, R., et al.[2022]

In a study of 302 patients with type 2 diabetes, the use of professional continuous glucose monitoring (CGM) significantly reduced HbA1c levels by an average of 0.439% compared to a control group, indicating improved glycemic control.

The CGM intervention also led to better glucose management, with increased time spent in the target glucose range, reduced time above 180 mg/dl, decreased glycemic variability, and improved dietary habits, including a reduction in daily caloric intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of professional continuous glucose monitoring as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes. Rivera-Ávila, DA., Esquivel-Lu, AI., Salazar-Lozano, CR., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10348002/

Long-term Continuous Glucose Monitor Use in Very Young ... Over 12 months young children with T1D using newer CGM technology sustained reductions in hypoglycemia and, in contrast to prior studies, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772628224000724

A combined diabetes and continuous glucose monitoring ... Benefit from this program was rated good/very good by 95.5 % with no statistically significant difference between glucose monitoring groups.

3. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-101/effectiveness-of-cgms

CGM l Effectiveness of CGMs l danatech Multiple research studies confirm the effectiveness of continuous glucose monitoring · Decreased HbA1C · Decreased glycemic variability · Increased time in range ...

4. diabetesjournals.org diabetesjournals.org/care/article/44/9/e171/138847/Continuous-Glucose-Monitoring-Improves-Glycemic

Continuous Glucose Monitoring Improves Glycemic Outcomes ... Continuous glucose monitoring improves glycemic outcomes in children with type 1 diabetes: real-world data from a population-based clinic.

5. e-dmj.org e-dmj.org/journal/view.php?doi=10.4093/dmj.2023.0125

The Role of Continuous Glucose Monitoring in Type 1 ... Their findings, based on real-world data from a single center, show that CGM use was associated with better glycemic control than BGM. After ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9196217/

CONTINUOUS GLUCOSE MONITORING AND TYPE 1 ... In this study, we confirmed that CGM is effective in achieving better control of type 1 DM by significantly improving HbA1c levels in a population of highly ...

7. diabetes.org diabetes.org/sites/default/files/2025-06/CGM-Guidance-06-10-25.pdf

Guidance for the Use of Continuous Glucose Monitoring in ... By 2016, about 30% of people with type 1 diabetes used a CGM for their management, with that number rising to approximately 70-80% in. 2022.1,2 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6708264/

Benefits and Barriers of Continuous Glucose Monitoring in ... CGM may address unique challenges of T1D in young children and increase parental comfort with diabetes management, yet there are multiple barriers.

9. diabetesjournals.org diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

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.

10. diabetes.org diabetes.org/sites/default/files/2024-04/CGM-guidance-4-24.pdf

Guidance for the Use of Continuous Glucose Monitoring in ... The purpose of this guidance document is to provide general information about the use of continuous glucose monitors (CGMs) in the school setting to monitor ...