NCT07296276

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: i-SENS, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 while maintaining their original diabetes mellitus treatment. The participants will draw capillary blood at least 8 times a day using the SMBG system between study visits. Between insertion and removal of the CareSens Air 3 the participants will be in the clinic 4 times to obtain accurate glucose reading from the reference device under carefully controlled circumstances including induction of low and high blood glucose.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	CareSens Air 3 primary insertion	Primary CareSens Air 3 device
DEVICE	CareSens Air 3 secondary insertion	Secondary CareSens Air 3 device

Timeline

• Start date: 2026-02-09
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-12-22
• Last updated: 2026-04-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study