A Prospective, Single Arm, Open-label, Interventional Study to Evaluate the Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With Type 1 Diabetes
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Adults who are 18-65 years of age, inclusive
• Patients with type 1 diabetes who use intensive insulin therapy (multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) including users of systems with continuous glucose monitoring (CGM) driven automatic adjustment of insulin doses for at least 3 months
• Patients who voluntarily decide to participate in the study and provide written informed consent
Locations
United States
California
Headlands Research AMCR
NOT_YET_RECRUITING
Escondido
Diablo Clinical Research
NOT_YET_RECRUITING
Walnut Creek
Georgia
Atlanta Diabetes Associates
NOT_YET_RECRUITING
Atlanta
Washington
Rainier Clinical Reseach Center
RECRUITING
Renton
Time Frame
Start Date: 2026-02-09
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 32
Treatments
Experimental: CareSens Air 3 primary insertion site
CareSens Air 3 primary insertion site
Experimental: CareSens Air 3 secondary insertion site
CareSens Air 3 secondary insertion site
Related Therapeutic Areas
Sponsors
Leads: i-SENS, Inc.
Collaborators: Integrated Medical Development