Continuous Glucose Monitoring for Type 2 Diabetes

Overseen By Natalia Garban

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Medical adhesive allergies

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well young people with Type 2 Diabetes can manage their blood sugar through a special educational program. It compares a new, in-depth curriculum for managing glucose levels with standard diabetes care. Participants will use a Continuous Glucose Monitor, which tracks blood sugar levels in real-time, and receive support through online materials and virtual sessions with a diabetes educator. The trial is ideal for those aged 8-21 who have been diagnosed with Type 2 Diabetes and can communicate in English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes education and management strategies.

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 Continuous Glucose Monitoring Academy curriculum is safe for youth with Type 2 Diabetes?

Research shows that continuous glucose monitors (CGMs) are generally safe for people with diabetes. These devices effectively manage blood sugar levels in both type 1 and type 2 diabetes, leading to better health and a more positive patient experience.

CGM systems like Dexcom and FreeStyle Libre are widely used and FDA-approved. They provide real-time updates on blood sugar levels, helping to prevent dangerous highs and lows. Many users report feeling less stressed about daily diabetes management.

Overall, CGMs are well-tolerated. Minor skin irritation from wearing the sensor may occur, but serious side effects are rare. For those considering a trial for a CGM education program, existing research suggests these devices are safe and helpful for managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Continuous Glucose Monitoring Academy because it offers a fresh, interactive approach to managing Type 2 diabetes. Unlike traditional treatments that often rely on periodic blood sugar checks and medication adjustments, this program empowers patients through problem-based learning and engaging online group sessions with specialists. By focusing on real-time glucose monitoring and personalized education, it aims to help individuals understand and manage their blood sugar levels more effectively, potentially leading to improved outcomes and a better quality of life for those with Type 2 diabetes.

What evidence suggests that the Continuous Glucose Monitoring Academy is effective for managing Type 2 Diabetes?

Research has shown that continuous glucose monitoring (CGM) can help people with type 2 diabetes manage their blood sugar more effectively. In this trial, participants in the Continuous Glucose Monitoring Academy arm will receive an interactive workbook and participate in online group sessions to learn about CGM and glucose management strategies. Studies have found that CGM benefits both insulin users and non-users by providing real-time glucose level monitoring, which enhances diabetes management and understanding. Specifically, another study found that using CGM improved patients' well-being and reduced diabetes-related stress. Overall, CGM is a promising tool for effectively managing type 2 diabetes. ^{1 5 6 7 8}

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 individuals aged 13-24 with Type 2 Diabetes who can speak, read, and write in English or Spanish. It's designed to help them manage their glucose levels better.

Inclusion Criteria

I am between 13 and 24 years old.

I have been diagnosed with type 2 diabetes.

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

Education

Participants engage in a four-week education program with online workbooks, videos, and virtual sessions with a diabetes educator.

4 weeks

4 virtual sessions

Clinical Review

Participants undergo a six-month clinical review to evaluate the impact of the education curriculum on glycemic outcomes.

6 months

Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after the education and clinical review phases.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitoring Academy

Trial Overview The study compares a specialized Continuous Glucose Monitoring Academy education program against standard diabetes care. Participants will learn glucose management through online resources and virtual sessions over four weeks, followed by six months of clinical review.

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring Academy Experimental Treatment 2 Interventions

Receive an interactive workbook with problem-based learning scenarios and video links about Continuous Glucose Monitoring and glucose management strategies (CGM Academy Program). 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: Control Placebo Group 1 Intervention

Receives standard of care, regular education in the clinic.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Continuous glucose monitoring (CGM) was analyzed in 53 diabetic patients, primarily those with type 1 diabetes (90.5%), and was found to be effective in detecting asymptomatic hypoglycemic events and guiding therapy changes in 64.5% of cases.

The method provided additional information that improved glycemic control and potentially life expectancy in type 1 diabetes patients, but it was noted to be less effective for type 2 diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. Bagosi, Z., Oroszlán, T., Bujtor, Z., et al.[2022]

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 5-week pilot study involving 9 subjects with type 1 diabetes, continuous glucose monitoring led to a significant reduction in HbA1c from 9.9% to 8.8%, indicating improved glycemic control without changing daily insulin usage.

The continuous glucose monitors accurately identified glucose patterns, allowing for therapy adjustments that would not have been possible with traditional blood glucose meter data, suggesting a valuable tool for managing diabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. Bode, BW., Gross, TM., Thornton, KR., et al.[2022]

Continuous glucose monitoring (CGM) is becoming a standard tool for managing type 1 diabetes, with advancements that may lead to its integration into closed-loop artificial beta-cell systems.

The review highlights the accuracy and performance of the two currently approved CGM devices, discussing their clinical trial results, limitations, and best practices for use in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in type 1 diabetes. Weinzimer, SA., Tamborlane, WV., Chase, HP., et al.[2019]

The Eversense continuous glucose monitoring (CGM) system showed a mean absolute relative difference (MARD) of 8.8% compared to reference glucose measurements, significantly surpassing the accuracy goal of 20%, indicating its effectiveness in monitoring glucose levels in individuals with type 1 and type 2 diabetes.

The study, involving 90 participants over 90 days, reported a favorable safety profile with only one serious adverse event (1.1%) related to sensor removal, and 91% of sensors remained functional throughout the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Christiansen, MP., Klaff, LJ., Brazg, R., et al.[2019]

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 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]

The new continuous glucose monitoring system (CGMS) was well tolerated by 20 children with type 1 diabetes over 7 days, with 90% of sensors still in use at the end of the study, indicating good patient acceptance and safety.

The study found that the CGMS could effectively function beyond the typical 72-hour limit, with 78% of sensors still operational after 7 days, suggesting that the device can provide extended monitoring without significant loss of accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus. Wong, LJ., Buckingham, BA., Kunselman, B., et al.[2009]

The analysis of adverse events for the Medtronic 670G insulin pump revealed that users experienced more hypoglycemic events when the auto mode was activated compared to when it was turned off.

For the Dexcom continuous glucose monitors, complaints about inaccuracies were most common when the readings fell within the acceptable range (B zone), indicating potential confusion among users regarding the reliability of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. Krouwer, JS.[2022]

Glucose meter evaluations show that while many devices perform well according to standards, there are still significant malfunctions reported, with 10,837 adverse events documented in the FDA's MAUDE database in just the first 7 months of 2018.

Using reliability growth management techniques could help reduce the failure rates of glucose meters by analyzing and addressing the issues highlighted in the MAUDE database.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Glucose Meter Adverse Events by Using Reliability Growth With the FDA MAUDE Database. Krouwer, JS.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06516640

Type 2 Continuous Glucose Monitoring Academy Change in perceived diabetes distress at baseline, week 4 & 6 months, The Type 2 Diabetes Distress Assessment System (T2-DDAS) measures how much overall ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34077499/

Effect of Continuous Glucose Monitoring on Glycemic Control ... Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy.

3. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70008

Continuous glucose monitoring in noninsulin‐treated type 2 ... CGM use in noninsulin-treated individuals living with T2DM was associated with improved glycaemic outcomes and patient experience, reduced ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1530891X25008985

Effects of Continuous Glucose Monitoring Versus Blood ... Conclusions. The CGM and BGM arms achieved similar and significant improvements in glycemia and other diabetes-related outcomes after 6 months in this MSKDP.

5. diabetes.org diabetes.org/newsroom/press-releases/breakthrough-studies-automated-insulin-delivery-and-cgm-type-2-diabetes

Breakthrough Studies on Automated Insulin Delivery and ... Findings from a new study demonstrate that CGM significantly enhances glycemic control in adults with type 2 diabetes who are not using insulin.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11843561/

Evaluation of the Effectiveness of Continuous Glucose ... Real-world evidence suggests CGMs provide improved clinical outcomes in patients with type 1 and type 2 diabetes including those with public ...

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 ... CGM alarms allow parents, school nurses, or trained staff to institute preventative measures to ensure the safety of a student with diabetes.

8. diabetesjournals.org diabetesjournals.org/care/article/42/8/1593/36184/Clinical-Targets-for-Continuous-Glucose-Monitoring

Clinical Targets for Continuous Glucose Monitoring Data ... Effective use of CGM data to optimize clinical outcomes requires the user to interpret the collected data and act upon them appropriately. This ...