Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM (Air3Pilot)

April 6, 2026 updated by: i-SENS, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92025
      • Walnut Creek, California, United States, 94598
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Not yet recruiting
        • Atlanta Diabetes Associates
        • Contact:
          • Amanda Maxson Clinical Research Manager, RN
          • Phone Number: 404-355-4393
    • Washington
      • Renton, Washington, United States, 98057
        • Recruiting
        • Rainier Clinical Reseach Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • The following abnormal skin or skin diseases or skin alterations at the CGM sensor attachment or insertion site: Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash, Staphylococcus aureus infection.
  • Allergic contact dermatitis to medical adhesives.
  • History of frequent catheter abscesses associated with pump therapy.
  • Severe hypoglycemia events within 3 months prior to screening. Severe hypoglycemia is defined as loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia.
  • Hypoglycemia unawareness.
  • Conditions that predispose to hypoglycemia including inadequately treated thyroid and adrenal disease.
  • Participants with diabetic ketoacidosis within 3 months prior to screening.
  • History of epilepsy or syncope within 6 months prior to screening.
  • Unstable vascular diseases (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy, including: Stroke, transitory cerebral ischemia, ischemic heart disease, peripheral vascular disease, and serious arrhythmia.
  • Patients with anemia (hemoglobin below normal range).
  • Patients scheduled for X-ray, MRI, CT or diathermy during the study.
  • Pregnant or lactating women or those who plan to become pregnant or do not agree to use an adequate method of contraception during the study.
  • Patients who are currently participating or participated within 2 weeks prior to screening in another study or plan to participate in another study that in the opinion of the investigator would affect the safety of the study participant or the study result.
  • Patients unwilling to abstain from ingesting the foodstuffs listed in Appendix 3 in excess of the allowed amounts.
  • Patients with cognitive impairment or who are not suitable for this study or may be at increased risk associated with study participation in the opinion of the investigator.
  • Wearing of a pace maker or other comparable medical devices.
  • HbA1c >9.5%.
  • Dependency from the sponsor or the clinical investigator.
  • Unwillingness and/or inability to comply with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CareSens Air 3 primary insertion site
Device: CareSens Air 3 primary insertion
Primary CareSens Air 3 device
Experimental: CareSens Air 3 secondary insertion site
Device: CareSens Air 3 secondary insertion
Secondary CareSens Air 3 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the glucose concentration measurements
Time Frame: 16 days
percentage of iCGM values in the measuring range less than 70 mg/dL (3.9 mmol/l) within +/- 15 mg/dL (0.83 mmol/l) of the reference venous glucose measurement by YSI analyzer
16 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precision of the glucose measurements
Time Frame: 16 days
Precision (absolute relative difference between simultaneous measurements between two CGM devices)
16 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

i-SENS, Inc.

Collaborators

Integrated Medical Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGM-008A-P102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The plan is to publish the results, but to keep the individual data proprietary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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