CGM Use for Diabetes

(REST Trial)

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

122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults with diabetes start and keep using continuous glucose monitors through a program that includes readiness assessment, remote education, and a sustainability plan. It targets older adults who are at higher risk of low blood sugar levels.

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 safety data is available for continuous glucose monitors (CGMs)?

Safety data for continuous glucose monitors (CGMs) includes information on adverse events and risks associated with their use. In 2022, there were 281,963 adverse events reported for CGMs, highlighting significant safety concerns. The FDA database contains detailed records of these events. Previous analyses, such as those from 2019, have identified issues like inaccurate readings and allergic skin reactions. Additionally, concerns about sensor accuracy, reliability, and risks from inaccurate readings have been noted in various studies. ^{1 2 3 4 5}

Is continuous glucose monitoring (CGM) safe for humans?

Continuous glucose monitors (CGMs) have been associated with adverse events, including allergic skin reactions and inaccurate readings, which can pose risks. However, they are widely used for managing diabetes and can improve outcomes with proper education and monitoring. ^{1 2 3 4 5}

Is Continuous Glucose Monitor (CGM) a promising treatment for diabetes?

Yes, Continuous Glucose Monitor (CGM) is a promising treatment for diabetes. It helps people manage their blood sugar levels better by providing continuous information about their glucose levels. This can lead to improved control of diabetes and reduce the risk of low blood sugar episodes. CGM is especially useful for people who need insulin and can help them make better lifestyle and medication choices. ^{5 6 7 8 9}

How is continuous glucose monitoring (CGM) different from other diabetes treatments?

Continuous glucose monitoring (CGM) is unique because it continuously tracks glucose levels in the body, providing real-time data and alerts for high or low blood sugar, unlike traditional methods that require periodic finger-prick tests. This allows for better glucose control and reduces the risk of hypoglycemia (low blood sugar) in people with diabetes. ^{5 6 7 8 9}

What data supports the idea that CGM Use for Diabetes is an effective treatment?

The available research shows that continuous glucose monitors (CGMs) are effective in helping people with diabetes manage their condition. They provide real-time information about blood sugar levels, which helps users improve their control over these levels. Studies have shown that CGMs help reduce the time spent with low blood sugar and improve overall blood sugar control in adults. While the benefits are more clearly proven in adults, they are less robust in children and teens. CGMs are especially useful when combined with insulin pumps, which can automatically adjust insulin delivery based on the data from the CGM. This makes CGMs a valuable tool for managing diabetes compared to traditional methods that require manual blood sugar checks. ^{5 8 10 11 12}

What data supports the effectiveness of the treatment Continuous Glucose Monitor (CGM) for diabetes?

Continuous Glucose Monitors (CGMs) have been shown to improve blood sugar control and reduce the time spent in low blood sugar (hypoglycemia) for adults with diabetes. They provide real-time glucose level readings, helping users manage their condition more effectively. ^{5 8 10 11 12}

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) 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]

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 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]

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) 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) 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]

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]

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]

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) 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]

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]

Citations

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

Continuous glucose monitoring: current use and future directions. [2022]

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

Use of continuous glucose monitoring as an outcome measure in clinical trials. [2022]

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

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

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

Continuous glucose monitoring in type 1 diabetes. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: A review of the technology and clinical use. [2022]

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

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

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

Clinical overview of continuous glucose monitoring. [2021]

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

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]

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

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. [2019]

10. Canada 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. [2023]

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

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Safety and Performance of Continuous Glucose Monitoring: An Overview. [2023]