CareSens Air 3 for Type 1 Diabetes
(Air3Pilot Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the accuracy of a new continuous glucose monitor, CareSens Air 3, for people with type 1 diabetes. It aims to assess how well this device measures blood sugar levels in real-life settings. The trial includes two groups using different sensor insertion spots to gather more data. Individuals with type 1 diabetes who use intensive insulin therapy, such as multiple daily injections or an insulin pump, may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to the development of innovative diabetes management tools.
What prior data suggests that the CareSens Air 3 device is safe for use in adults with type 1 diabetes?
Research has shown that the CareSens Air 3 device is easy to use. In earlier studies, participants used the CareSens Air 3 for 15 days, and it accurately measured blood sugar levels. Users reported satisfaction with the device, and no serious side effects occurred. This suggests that the device is safe for people with type 1 diabetes.12345
Why are researchers excited about this trial?
Researchers are excited about the CareSens Air 3 for Type 1 Diabetes because it offers a novel approach to glucose monitoring. Unlike traditional glucose meters that require multiple finger pricks, the CareSens Air 3 uses a less invasive method, potentially improving comfort and ease of use for patients. It features both a primary and secondary insertion site, increasing flexibility and convenience for users. This could lead to better adherence to monitoring and overall diabetes management.
What evidence suggests that the CareSens Air 3 is effective for type 1 diabetes?
Research has shown that continuous glucose monitoring (CGM) can help people with diabetes control their blood sugar levels more effectively. Participants in this trial will use the CareSens Air 3, a CGM device known for its strong accuracy. One study found the updated technology in CareSens Air 3 to be 93.9% accurate. Another study demonstrated that for people with type 1 diabetes, the device had a mean absolute relative difference (MARD) of 10.62%, a measure of accuracy. These results suggest that CareSens Air 3 can effectively track blood sugar levels, aiding people with type 1 diabetes in better managing their condition.12678
Are You a Good Fit for This Trial?
This trial is for adults with Type 1 Diabetes who want to test the accuracy and precision of a new continuous glucose monitoring system called 'CareSens Air 3'. Specific eligibility criteria are not provided, but typically participants should be in stable health.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Device Wearing
Participants wear two CareSens Air 3 and one Libre 3 Plus for 16 days without access to glucose values from the CareSens Air 3 devices while maintaining their original diabetes mellitus treatment.
Follow-up
Participants are monitored for safety and effectiveness after device removal
What Are the Treatments Tested in This Trial?
Interventions
- CareSens Air 3
Trial Overview
The study is testing how well the 'CareSens Air 3' device measures blood sugar levels in real-time. It's an open-label pilot study, meaning everyone knows they're getting the device and it's an initial test before larger studies.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
CareSens Air 3 secondary insertion site
CareSens Air 3 primary insertion site
Find a Clinic Near You
Who Is Running the Clinical Trial?
i-SENS, Inc.
Lead Sponsor
Integrated Medical Development
Industry Sponsor
Citations
Accuracy and Precision of the Continuous Glucose ...
Participants will wear two CareSens Air 3 and one Libre 3 Plus for 16 days without access to glucose values from the CareSens Air 3 devices ...
Comparative Performance Analysis of Manual and ...
The CSAir's updated algorithm exhibited improved accuracy compared with the manual calibration algorithm, with a total 20/20 AR of 93.9% (vs 90.1%) and an MARD ...
Advances in Continuous Glucose Monitoring: Clinical ...
Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.
The History, Evolution and Future of Continuous Glucose ...
Real-world evidence on clinical outcomes of people with type 1 diabetes using open-source and commercial automated insulin dosing systems: A systematic ...
Accuracy and Safety of the 15-Day CareSens Air ...
Accuracy by diabetes type is presented in Table 4. The MARD was 10.62% in patients with type 1 diabetes and 9.85% in patients with type 2 diabetes. Table 3.
Accuracy and Safety of the 15-Day CareSens Air ...
Background: We evaluated the accuracy and safety of the CareSens Air, a novel real-time continuous glucose monitoring system (CGMS), during 15 days of use ...
Accuracy and Safety of the 15-Day CareSens Air ...
Conclusions: The CareSens Air demonstrated accurate performance across the wide glycemic range and was well tolerated during the 15-day sensor use period.
8.
semanticscholar.org
semanticscholar.org/paper/Accuracy-of-the-Third-Generation-of-a-14-Day-System-Alva-Brazg/2c15c84edc1b6dc90997298ba95e5421043c8443Accuracy of the Third Generation of a 14-Day Continuous ...
The FSL3 CGM system demonstrated accurate performance across the dynamic glycemic range during the 14-day sensor wear period and no serious adverse events ...
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