Continuous Glucose Monitoring for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how continuous glucose monitoring (CGM) can enhance diabetes care after metabolic surgery, such as gastric bypass or sleeve gastrectomy. CGM devices, like the Abbot Freestyle Libre CGM, provide real-time insights into blood sugar patterns, aiding in tracking changes and identifying complications post-surgery. Participants include adults with type 2 diabetes who struggle to control their condition with medication and have a BMI of 35 or higher. The trial compares those using CGM to those using standard blood sugar self-checks to determine which method yields better results. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve diabetes management after surgery.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on insulin therapy before surgery, you are not eligible to participate.
What prior data suggests that continuous glucose monitoring is safe for diabetes patients?
Research shows that the Abbott Freestyle Libre Continuous Glucose Monitoring (CGM) system is generally safe for use. Safety data indicate very few side effects. Reports also show that most people do not experience issues when applying or removing the sensor.
Additionally, the FDA has approved the Abbott Freestyle Libre system for managing diabetes, supporting its safety. This approval means the device underwent thorough testing to ensure safety for people with diabetes. However, discussing any safety concerns or questions with a doctor before joining a trial is always important.12345Why are researchers excited about this trial?
Researchers are excited about the Abbot Freestyle Libre CGM because it offers a new way for people with diabetes to monitor their blood sugar levels continuously without the need for constant finger pricks. Unlike traditional self-monitoring blood glucose (SMBG) methods, which require multiple daily tests, the Freestyle Libre CGM provides real-time glucose readings through a sensor worn on the skin. This innovative approach not only improves convenience and comfort for users but also provides more comprehensive data to help manage diabetes more effectively.
What evidence suggests that continuous glucose monitoring is effective for diabetes?
Research has shown that the Abbott Freestyle Libre Continuous Glucose Monitoring (CGM) system can help people manage diabetes more effectively. On average, users experience a 0.9% reduction in HbA1c levels within 3 to 6 months, indicating improved blood sugar control. This technology also correlates with a 78% decrease in hospital visits for heart problems among people with diabetes. Participants in this trial may join the CGM group to use this system, which provides real-time glucose level information, aiding in safer and more effective blood sugar management. These benefits make it a promising tool for improving diabetes control.13678
Are You a Good Fit for This Trial?
This trial is for adults with obesity and type 2 diabetes who may benefit from metabolic surgery. It aims to assess the effectiveness of continuous glucose monitoring (CGM) post-surgery. Specific eligibility criteria are not provided, but typically participants would need a diagnosis of obesity and type 2 diabetes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Surgery Monitoring
Participants undergo continuous glucose monitoring (CGM) to establish baseline glycemic patterns before metabolic surgery
Surgery and Immediate Post-Surgery Monitoring
Participants undergo metabolic surgery (Roux-en-Y gastric bypass or vertical sleeve gastrectomy) and are monitored using CGM for immediate post-surgery glycemic changes
Long-term Follow-up
Participants are monitored for long-term glycemic control and post-bariatric hypoglycemia using CGM
What Are the Treatments Tested in This Trial?
Interventions
- Abbot Freestyle Libre CGM
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pennington Biomedical Research Center
Lead Sponsor
LA CaTS Clinical Research Resources Core
Collaborator