CGM Use for Diabetes
(REST Trial)
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.12345
Is continuous glucose monitoring (CGM) safe for humans?
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.56789
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.56789
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.58101112
What data supports the effectiveness of the treatment Continuous Glucose Monitor (CGM) for diabetes?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Readiness and Education
Participants are assessed for readiness and barriers to CGM initiation and receive remote education
Sustainability Framework Implementation
Implementation of a framework for sustained CGM use and monitoring of CGM adoption and effectiveness
Follow-up
Participants are monitored for safety, effectiveness, and quality of life measures after the main intervention
What Are the Treatments Tested in This Trial?
Interventions
- Continuous Glucose Monitor
Continuous Glucose Monitor is already approved in United States, European Union, Canada, Japan for the following indications:
- Type 1 Diabetes
- Type 2 Diabetes
- Insulin-treated Diabetes
- Type 1 Diabetes
- Type 2 Diabetes
- Gestational Diabetes
- Type 1 Diabetes
- Type 2 Diabetes
- Type 1 Diabetes
- Type 2 Diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joslin Diabetes Center
Lead Sponsor
State University of New York - Upstate Medical University
Collaborator
Cecilia Health
Collaborator