RecruitingNot ApplicableNCT07296276

Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM

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


Sponsor

i-SENS, Inc.

Enrollment

32 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests the accuracy of a new continuous glucose monitoring (CGM) device called CareSens Air 3 in adults with type 1 diabetes, comparing its readings to standard blood sugar measurements. **You may be eligible if...** - You are between 18 and 65 years old - You have type 1 diabetes - You use intensive insulin therapy — either multiple daily injections or an insulin pump - You have been using a CGM-driven insulin adjustment system for at least 3 months **You may NOT be eligible if...** - You have severe skin conditions or large tattoos at the CGM sensor site - You have an allergy to medical adhesives - You had a severe low blood sugar episode (loss of consciousness or seizure) in the past 3 months - You have had diabetic ketoacidosis in the past 3 months - You have conditions that cause unpredictable low blood sugar (such as untreated thyroid or adrenal disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECareSens Air 3 primary insertion

Primary CareSens Air 3 device

DEVICECareSens Air 3 secondary insertion

Secondary CareSens Air 3 device


Locations(4)

Headlands Research AMCR

Escondido, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Rainier Clinical Reseach Center

Renton, Washington, United States

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NCT07296276


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