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

NCT07296276 | Recruiting FDA Device

• 1 other identifier: CGM-008A-P102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Accuracy of the glucose concentration measurements

  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 Outcomes (1)

• Precision of the glucose measurements

  16 days

Study Arms (2)

CareSens Air 3 primary insertion site

EXPERIMENTAL

CareSens Air 3 primary insertion site

Device: CareSens Air 3 primary insertion

CareSens Air 3 secondary insertion site

EXPERIMENTAL

CareSens Air 3 secondary insertion site

Device: CareSens Air 3 secondary insertion

Interventions

CareSens Air 3 primary insertion DEVICE

Primary CareSens Air 3 device

CareSens Air 3 primary insertion site

CareSens Air 3 secondary insertion DEVICE

Secondary CareSens Air 3 device

CareSens Air 3 secondary insertion site

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• i-SENS, Inc.: lead
• Integrated Medical Development: collaborator

Study Sites (4)

Headlands Research AMCR

Escondido, California, 92025, United States

NOT YET RECRUITING

Diablo Clinical Research

Walnut Creek, California, 94598, United States

RECRUITING

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

NOT YET RECRUITING

Rainier Clinical Reseach Center

Renton, Washington, 98057, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The CareSens Air 3 data will neither be available to the investigational site nor the participants during the course of the study.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Induction of low and high blood glucose.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 22, 2025
• Study Start: February 9, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)