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?

The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D): * The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies. * The second aim is to evaluate the effects of the Continuous Glucose Monitoring Academy metrics. * The third aim is to explore the relationships between these metrics with diabetes distress, diabetes family responsibilities, and process metrics. Participants will join for a total of four weeks of education, followed by a six-month clinical review. They will have access to an online workbook and videos, and will participate in virtual sessions with a diabetes educator who will cover glucose management strategies in-depth. Participants will wear their preferred Continuous Glucose Monitoring system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.

Will I have to stop taking my current medications?

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

Is continuous glucose monitoring generally safe for humans?

Continuous glucose monitors (CGMs) have been associated with adverse events, including allergic skin reactions and inaccurate readings, as reported in FDA databases. However, they are widely used in managing diabetes, and many users tolerate them well, even during regular activities. ^{1 2 3 4 5}

How is Continuous Glucose Monitoring Academy different from other treatments for type 2 diabetes?

Continuous Glucose Monitoring Academy is unique because it uses a wearable device that continuously tracks glucose levels in the body, providing real-time data and alerts for high or low blood sugar, unlike traditional methods that require frequent finger-stick tests. This approach helps patients and doctors better understand and manage blood sugar patterns, potentially reducing complications like hypoglycemia (low blood sugar) and improving overall diabetes control. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Continuous Glucose Monitoring Academy for Type 2 Diabetes?

Research shows that continuous glucose monitoring helps people with diabetes better understand their blood sugar patterns, which can lead to improved blood sugar control and lower hemoglobin A1c levels. This technology has been effective in both type 1 and type 2 diabetes, helping patients make informed decisions about their diet, insulin, and lifestyle. ^{5 7 8 11 12}

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

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 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 (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]

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]

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]

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]

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]

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 (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]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. [2022]

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

Continuous Glucose Monitoring for the Internist. [2022]

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

Continuous glucose monitoring in type 1 diabetes. [2019]

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

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

5. France pubmed.ncbi.nlm.nih.gov

Real-time continuous glucose monitoring using GuardianRT: from research to clinical practice. [2007]

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

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

8. United States 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. [2009]

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

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

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

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. [2019]

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

Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities. [2023]

12. Hungary pubmed.ncbi.nlm.nih.gov

[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. [2022]