CGM Use for Diabetes

(REST Trial)

Not currently recruiting at 1 trial location

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Joslin Diabetes Center

Must be taking: Insulin

Must not be taking: Acetaminophen, Hydroxyurea

Disqualifiers: End-stage renal disease, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults with diabetes manage their condition using a continuous glucose monitor (CGM). It targets individuals with Type 1 or Type 2 diabetes who follow complex insulin routines but struggle to maintain their blood sugar within the recommended range. The study tests a new approach, the REST model, designed to simplify the initiation and continued use of CGM technology. Ideal candidates are those aged 65 and older, using insulin multiple times a day or an insulin pump, and willing to use a smartphone for the CGM device. As an unphased trial, this study offers participants the chance to contribute to innovative diabetes care solutions and enhance their own management strategies.

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

The trial does not specify if you need to stop taking your current medications. However, if you are on acetaminophen over 4 grams per day or hydroxyurea therapy, you may not be eligible due to interference with the CGM sensor readings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot be on high doses of acetaminophen or hydroxyurea due to interference with the CGM sensor readings.

What prior data suggests that continuous glucose monitoring is safe for older adults with diabetes?

Research has shown that continuous glucose monitors (CGMs) are generally safe for people with diabetes. These devices track blood sugar levels in real time. Studies have found that CGMs can reduce the risk of low blood sugar episodes and improve overall blood sugar control in both Type 1 and Type 2 diabetes.

The FDA has approved devices like the Dexcom G4 PLATINUM for monitoring blood sugar trends, confirming their safety. Additionally, research suggests that CGMs can improve health outcomes and lower healthcare costs for people with diabetes.

Overall, CGMs are well-tolerated, with few reports of serious side effects. Most users find them helpful and safe for managing their diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Continuous Glucose Monitors (CGMs) for diabetes because they offer real-time tracking of glucose levels, which is a significant step up from traditional fingerstick blood tests. Unlike standard glucose testing methods that provide only snapshots of glucose levels, CGMs deliver continuous data throughout the day and night, helping users to better manage their condition. Additionally, CGMs can alert users to dangerous fluctuations in glucose levels before they become critical, potentially reducing the risk of complications. This continuous monitoring empowers individuals with diabetes to make more informed decisions about their diet, exercise, and medication, ultimately leading to improved overall management of the condition.

What evidence suggests that the REST model is effective for facilitating CGM use in older adults with diabetes?

Studies have shown that a continuous glucose monitor (CGM) can greatly help people with diabetes control their blood sugar levels. Research indicates that a CGM device allows for closer tracking of glucose levels, leading to better diabetes management. Users of CGMs often see improvements in their A1c levels, a measure of average blood sugar over time. Additionally, CGM use has been linked to fewer healthcare needs by preventing episodes of high and low blood sugar. These benefits suggest that CGM is a valuable tool for managing diabetes, especially for older adults on complex insulin plans. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or above with Type 1 or Type 2 Diabetes, who are on complex insulin regimens and have not used a Continuous Glucose Monitor (CGM) before or aren't meeting their glycemic goals. Participants must be willing to wear the CGM device at all times and use a smartphone for data upload.

Inclusion Criteria

I take insulin more than 3 times a day or use an insulin pump.

I have had type 1 or type 2 diabetes for over a year.

My blood sugar often drops below 70 mg/dL or stays within 70-180 mg/dL less than 40% of the time.

Exclusion Criteria

I take more than 4 grams of acetaminophen daily.

I use a hybrid closed-loop system for my condition.

My kidney function is severely reduced.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Readiness and Education

Participants are assessed for readiness and barriers to CGM initiation and receive remote education

6 months

Remote education sessions

Sustainability Framework Implementation

Implementation of a framework for sustained CGM use and monitoring of CGM adoption and effectiveness

6 months

Remote and in-person visits as needed

Follow-up

Participants are monitored for safety, effectiveness, and quality of life measures after the main intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor

Trial Overview The study tests the REST model's effectiveness in helping older adults adopt and keep using a CGM. It will also explore how this model affects quality of life and economic factors, aiming to create a sustainable framework for CGM use.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Continuous Glucose Monitor is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes
• Insulin-treated Diabetes

Approved in European Union as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes
• Gestational Diabetes

Approved in Canada as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes

Approved in Japan as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials

98

Recruited

26,500+

State University of New York - Upstate Medical University

Collaborator

Trials

176

Recruited

27,600+

Cecilia Health

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

Continuous glucose monitoring (CGM) shows a high level of agreement with traditional reference glucose measurements in individuals with type 1 diabetes, indicating it can be a reliable tool for assessing glucose levels in clinical studies.

Despite some minor discrepancies in extreme glucose values, CGM can effectively capture overall glycemic control and variability, making it a valuable outcome measure for clinical trials involving diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of continuous glucose monitoring as an outcome measure in clinical trials. Beck, RW., Calhoun, P., Kollman, C.[2022]

Continuous glucose monitors (CGMs) have been shown to significantly improve metabolic control and reduce hypoglycemia in adults with diabetes, based on large clinical trials.

Data supporting the benefits of CGMs in children and adolescents is less robust, indicating a need for further research, especially regarding insulin dosing algorithms and their effectiveness in younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in type 1 diabetes. Mauras, N., Fox, L., Englert, K., et al.[2021]

Continuous glucose monitoring (CGM) devices are now widely available in the U.S. for both consumer purchase and research, providing a new tool for diabetes management.

CGM technology allows for real-time monitoring of glucose levels, which can help individuals manage their diabetes more effectively, as well as enabling retrospective analysis of glucose data for better long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical overview of continuous glucose monitoring. Buckingham, B.[2021]

Continuous glucose monitoring (CGM) significantly improves diabetes management for insulin-requiring patients, particularly in type 1 diabetes, by providing real-time insights into glycemic fluctuations and allowing for better lifestyle and medication adjustments.

The review highlights that CGM can lead to improved hemoglobin A1c (A1C) levels, reduced hypoglycemia, and enhanced quality of life, suggesting its potential benefits for broader patient populations with proper education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: A review of the technology and clinical use. Klonoff, DC., Ahn, D., Drincic, A.[2022]

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]

Continuous glucose monitoring (CGM) significantly improves glycemic control in diabetes patients compared to traditional monitoring methods, helping to reduce both the frequency and severity of hypoglycemic episodes.

CGM technology plays a crucial role in the development of the 'artificial pancreas', highlighting its importance in advancing diabetes management and treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Performance of Continuous Glucose Monitoring: An Overview. Singh, H., Venkatesan, V.[2023]

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 monitors (CGMs) have been shown to provide accurate glucose readings, making them a reliable tool for individuals with diabetes and their healthcare providers.

Recent clinical trials highlight the practical benefits of CGMs, demonstrating their effectiveness in managing diabetes and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implications of Accuracy Measurements of Continuous Glucose Sensors. Bailey, TS.[2018]

The new seventh-generation (G7) continuous glucose monitoring (CGM) device significantly reduces the number of tasks required for deployment compared to the sixth-generation (G6), making it easier for older adults and diabetes care specialists to use.

With a high usability score of 92.8, the G7 CGM device is reported to have a low cognitive burden, which may lead to better diabetes management outcomes for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Teachability of Continuous Glucose Monitoring Devices in Older Adults and Diabetes Educators: Task Analysis and Ease-of-Use Survey. Psavko, S., Katz, N., Mirchi, T., et al.[2023]

Continuous glucose monitoring (CGM) technology allows for real-time tracking of glucose levels, helping users manage their blood sugar more effectively without increasing the risk of hypoglycemia.

Key challenges for CGM include ensuring sensor accuracy, reliability, and comfort, which are essential for advancing towards artificial pancreas systems that automate blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. DeSalvo, D., Buckingham, B.[2022]

The new continuous glucose monitoring (CGM) system demonstrated strong accuracy over a 10-day period, with a mean absolute relative difference of 9.6%, indicating reliable glucose readings for users.

With 99.6% of measurements categorized as 'no' or 'slight' risk for discrepancies compared to self-monitored blood glucose values, this CGM system supports its use in diabetes management without the need for adjunctive testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. Hughes, J., Welsh, JB., Bhavaraju, NC., et al.[2019]

Continuous Glucose Monitoring (CGM) devices, including real-time (rtCGM) and intermittently scanned (isCGM), significantly improve glucose control and reduce hypoglycemia in insulin-treated individuals with diabetes, based on recent clinical evidence.

An updated algorithm was developed to help healthcare providers choose the most suitable CGM device for different clinical scenarios, such as type 1 and type 2 diabetes, pregnancy, and frailty, ensuring a personalized approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. Maiorino, MI., Buzzetti, R., Irace, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460137/

The Effectiveness of Continuous Glucose Monitoring ... The results of our study demonstrated that the adoption of CGM device leads to significant improvements in glycemic control, as evidenced by a ...

2. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) Real-time continuous glucose monitoring has led to tremendous outcomes for people with diabetes who, without a CGM, may have experienced potentially life- ...

3. diabetesjournals.org diabetesjournals.org/care/article/48/9/1581/163057/Real-Time-Continuous-Glucose-Monitoring-in

Real-Time Continuous Glucose Monitoring in Pregnancies ... CGM provides 72 times more glucose data than conventional four times per day CBG monitoring. Patients can benefit from real-time CGM data and ...

4. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.24255

Initiating continuous glucose monitoring is associated with ... This study showed that CGM use in patients with diabetes was associated with clinically meaningful improvements in A1c and reduced health care resource ...

5. e-enm.org e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ... Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8861781/

Demonstrating the Clinical Impact of Continuous Glucose ... Data from this study demonstrated that a CGM device improved patient health, decreased utilization, and reduced PMPM cost in a cohort of patients with diabetes.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/P120005S018b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/articles/continuous-glucose-monitoring-cgm

Continuous Glucose Monitoring (CGM): What It Is Several studies show that people with Type 1 and Type 2 diabetes who use a CGM have fewer episodes of low blood sugar and a lower A1C. A CGM device can: Show ...

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.