60 Participants Needed

Continuous Glucose Monitoring for Type 2 Diabetes

RS
RB
NG
Overseen ByNatalia Garban
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Los Angeles

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.12345

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.678910

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.5781112

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 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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Continuous Glucose Monitoring AcademyExperimental Treatment2 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: ControlPlacebo Group1 Intervention
Receives standard of care, regular education in the clinic.

Find a Clinic Near You

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

Citations

Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. [2022]
Continuous Glucose Monitoring for the Internist. [2022]
Continuous glucose monitoring in type 1 diabetes. [2019]
Continuous Glucose Monitoring: A Review of Available Systems. [2020]
Real-time continuous glucose monitoring using GuardianRT: from research to clinical practice. [2007]
Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]
Reducing Glucose Meter Adverse Events by Using Reliability Growth With the FDA MAUDE Database. [2020]
Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus. [2009]
An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities. [2023]
[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. [2022]
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