Continuous Glucose Monitoring for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to find out how well a new continuous glucose monitor works for people with diabetes. This study will test the performance of the study sensor(s) for 7-14 days of wear in patients who are 11-80 years old with type 1 or type 2 diabetes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you have type 1 diabetes and are using pramlintide, DPP-4 inhibitors, GLP-1 receptor agonists, metformin, or SGLT2 inhibitors, you cannot participate. Also, if you are using hydroxyurea, you cannot join the study.
Is continuous glucose monitoring safe for humans?
Continuous glucose monitoring systems, including flash glucose monitoring, have been evaluated for safety in various studies. One study specifically looked at the safety and patient tolerance of a new system in children with type 1 diabetes, allowing them to participate in normal activities, suggesting it is generally safe for use.12345
How is continuous glucose monitoring different from other diabetes treatments?
Continuous glucose monitoring (CGM) is unique because it provides real-time data on glucose levels by measuring the glucose in the fluid between cells, allowing for immediate adjustments in diabetes management. Unlike traditional methods that require finger-prick blood tests, CGM systems like the flash glucose monitoring (FGM) allow users to scan a sensor for on-demand access to glucose data, helping to prevent high and low blood sugar events.15678
What data supports the effectiveness of the treatment Continuous Glucose Monitoring for Diabetes?
Research shows that using flash continuous glucose monitoring (CGM) helps people with diabetes keep their blood sugar levels within the target range more often and reduces the time spent in high or low blood sugar levels. This technology provides immediate information, allowing users to make quick adjustments to their treatment, which has been shown to improve health outcomes in both type 1 and type 2 diabetes.257910
Are You a Good Fit for This Trial?
This trial is for people aged 11-80 with either type 1 or type 2 diabetes. It's designed to test a new continuous glucose monitor over a period of 7-14 days.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants wear the continuous glucose monitor for 7-14 days to test its performance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Continuous Glucose Monitoring
Continuous Glucose Monitoring is already approved in United States, European Union, Canada, Japan for the following indications:
- Type 1 diabetes
- Type 2 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?
Medtronic Diabetes
Lead Sponsor
Geoff Martha
Medtronic Diabetes
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Kweli Thompson
Medtronic Diabetes
Chief Medical Officer since 2022
MD from Harvard Medical School