Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM
Part of paid clinical trials in Escondido, California.
- Sponsor
- i-SENS, Inc.
- Study ID
- NCT07296276
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- CareSens Air 3 primary insertion — DEVICEPrimary CareSens Air 3 device
- CareSens Air 3 secondary insertion — DEVICESecondary CareSens Air 3 device
Study Details
This is a prospective, single arm, open-label, interventional, pilot study to evaluate the accuracy and precision of the continuous glucose monitoring (CGM) system of i-SENS, Inc., CareSens Air 3, in adult patients with type 1 diabetes.
Key Dates
- Start date
- Feb 9, 2026
- Status verified
- Feb 2026
- Primary completion
- Apr 30, 2026
- Completion
- Apr 30, 2026
Study Design
- Enrollment
- 32 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: CareSens Air 3 primary insertion siteCareSens Air 3 primary insertion site
- Experimental: CareSens Air 3 secondary insertion siteCareSens Air 3 secondary insertion site
Primary Outcome Measure
Accuracy of the glucose concentration measurements [ Time Frame: 16 days ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Headlands Research AMCR | Escondido | California | 92025 | |
| Diablo Clinical Research | Walnut Creek | California | 94598 | |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | Amanda Maxson Clinical Research Manager, RN 404-355-4393 |
| Rainier Clinical Reseach Center | Renton | Washington | 98057 |
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