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

NCT07296276 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

CareSens Air 3 primary insertion

Primary CareSens Air 3 device

DEVICE

CareSens Air 3 secondary insertion

Secondary CareSens Air 3 device

Sponsors & Collaborators

  • Integrated Medical Development

    collaborator INDUSTRY

  • i-SENS, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07296276 on ClinicalTrials.gov