90 Participants Needed

CGM Academy for Type 1 Diabetes

RB
RS
NG
Overseen ByNatalia Garban
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (CGM) device. The main questions the study aims to answer are:* Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education?* Explore relationships between participant's glycemic outcomes with diabetes distress, diabetes family responsibilities, and number of hours of diabetes education.Participants in the intervention group will:* 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.Participants in the comparison group will:* receive standard education provided to all patients at CHLA* complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

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 safety data is available for the CGM Academy for Type 1 Diabetes?

The research provided does not directly address safety data specific to the CGM Academy or Continuous Glucose Monitoring Education Program. However, it mentions that there were 281,963 adverse events related to continuous glucose monitors (CGMs) in 2022, as recorded in the FDA database. This indicates that while CGMs are widely used, they are associated with a significant number of adverse events, which could be relevant to the safety considerations of any CGM-related educational program.12345

Is the CGM Academy for Type 1 Diabetes 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 should be considered.12345

Is the CGM Academy treatment a promising way to help people with Type 1 Diabetes?

Yes, the CGM Academy treatment is promising because it helps people with Type 1 Diabetes learn how to use continuous glucose monitoring (CGM) technology effectively. This education program supports patients in managing their diabetes better by teaching them how to monitor their blood sugar levels continuously, which can lead to improved health outcomes.23678

How is the CGM Academy treatment different from other treatments for type 1 diabetes?

The CGM Academy treatment is unique because it focuses on educating patients to use continuous glucose monitoring (CGM) technology effectively, providing real-time insights into blood sugar levels, which helps in better managing diabetes compared to traditional methods that only offer occasional glucose snapshots.23678

What data supports the idea that CGM Academy for Type 1 Diabetes is an effective treatment?

The available research shows that educational programs for continuous glucose monitoring (CGM) can be effective for managing type 1 diabetes. For example, a study on adolescents with type 1 diabetes found that an educational intervention helped them make better daily therapy decisions using CGM data. Another study demonstrated that a structured education program improved the time spent in a healthy blood sugar range for children and young people with type 1 diabetes. These findings suggest that CGM Academy, which focuses on education and support, can be an effective treatment for managing type 1 diabetes.368910

What data supports the effectiveness of the treatment CGM Academy, Continuous Glucose Monitoring Education Program, for Type 1 Diabetes?

Research shows that educational programs for continuous glucose monitoring (CGM) can help people with diabetes better manage their condition by improving their understanding and use of CGM technology. For example, structured education programs have been shown to improve glucose control in children and young people with type 1 diabetes.368910

Who Is on the Research Team?

RB

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.
See 1 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: CGM AcademyExperimental Treatment1 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 EducationActive Control1 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.

Find a Clinic Near You

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 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.
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]
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.
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]
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.
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

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]
Continuous glucose monitoring technology for personal use: an educational program that educates and supports the patient. [2018]
The effects of professional continuous glucose monitoring as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes. [2022]
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. [2022]
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. [2022]
Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]
Experience with the Enlite sensor in a multicenter pediatric study. [2022]
Issues for the coming age of continuous glucose monitoring. [2018]
Continuous glucose monitoring in the hospital: an update in the era of COVID-19. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Continuous glucose monitoring has left the station: are you onboard? [2007]
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