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 — DEVICE
    Primary CareSens Air 3 device
  • CareSens Air 3 secondary insertion — DEVICE
    Secondary 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 site
    CareSens Air 3 primary insertion site
  • Experimental: CareSens Air 3 secondary insertion site
    CareSens Air 3 secondary insertion site

Primary Outcome Measure

Accuracy of the glucose concentration measurements [ Time Frame: 16 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Headlands Research AMCREscondidoCalifornia92025
Site Director
760-466-1523
Diablo Clinical ResearchWalnut CreekCalifornia94598
Principal Investigator, MD
925-930-7267
Atlanta Diabetes AssociatesAtlantaGeorgia30318
Amanda Maxson Clinical Research Manager, RN
404-355-4393
Rainier Clinical Reseach CenterRentonWashington98057
Principal Investigator, MD
425-251-1720

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