Continuous Glucose Monitoring for Gastroparesis in Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
A pilot study to evaluate and compare glucose metrics using a real-time continuous glucose monitor (FreeStyle Libre 3 sensor) between patients with diabetes and gastroparesis and those with diabetes without gastroparesis.
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop certain medications. If you're on opiates, GLP-1 agonists, or motility medications, you must stop them before joining the trial. Specifically, you need to wait 2 weeks after your last dose of GLP-1 agonists and 1 week after your last dose of motility medications before enrolling.
Will I have to stop taking my current medications?
If you are taking opiates, GLP-1 agonists, or motility medications, you will need to stop them before joining the trial. Specifically, you must wait 2 weeks after your last dose of opiates or GLP-1 agonists, and 1 week after your last dose of motility medications before enrolling.
What safety data exists for the FreeStyle Libre 3 glucose monitoring system?
The safety data for the FreeStyle Libre glucose monitoring system includes reports of allergic contact dermatitis caused by isobornyl acrylate in the sensor. Additionally, there is a study evaluating the safety and effectiveness of a similar continuous glucose monitoring system, the FreeStyle Navigator, for home use by adults with diabetes. These studies suggest that while the system is generally safe, there may be skin-related side effects for some users.12345
Is the FreeStyle Libre 3 continuous glucose monitoring system safe for humans?
Is continuous glucose monitoring a promising treatment for gastroparesis in diabetes?
How is continuous glucose monitoring unique for treating gastroparesis in diabetes?
Continuous glucose monitoring (CGM) is unique for treating gastroparesis in diabetes because it provides real-time tracking of glucose levels, which can help manage the unpredictable blood sugar fluctuations caused by gastroparesis. Unlike traditional methods that require finger-prick blood tests, CGM uses a sensor under the skin to continuously measure glucose, offering more detailed insights into glucose trends and helping to adjust treatment plans more effectively.24678
What data supports the idea that Continuous Glucose Monitoring for Gastroparesis in Diabetes is an effective treatment?
The available research shows that the FreeStyle Libre system, a type of continuous glucose monitoring, is effective for diabetes management. It provides continuous glucose readings without the need for frequent finger pricks, which can improve the quality of life for patients. Although the studies focus on diabetes in general, they highlight the system's accuracy and convenience, which can be beneficial for managing conditions like gastroparesis in diabetes. However, there is no specific data in the provided research directly linking it to gastroparesis treatment.23489
What data supports the effectiveness of the treatment FreeStyle Libre 3 continuous glucose monitoring sensor for gastroparesis in diabetes?
The FreeStyle Libre system, used for continuous glucose monitoring, has been shown to be accurate and effective in managing blood sugar levels in people with diabetes, as it provides continuous data without the need for frequent finger pricks. This can help improve overall glucose control, which is beneficial for managing diabetes-related conditions like gastroparesis.23489
Who Is on the Research Team?
Samita Garg, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults over 18 with type 1 or type 2 diabetes and a recent Hemoglobin A1c ≤11%. It's specifically for those who've had diabetes for at least a year without severe incidents in the past three months. Participants should have gastroparesis symptoms for three months, confirmed by tests, and must use a smartphone compatible with the LibreView App.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the FreeStyle Libre 3 sensor for Continuous Glucose Monitoring and participate in standardized meal challenges over a period of 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FreeStyle Libre 3 continuous glucose monitoring sensor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Samita Garg
Lead Sponsor