CareSens Air 3 continuous glucose monitor accuracy and precision in adults with type 1 diabetes

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 study will test whether the CareSens Air 3 continuous glucose monitor gives accurate and consistent glucose readings for adults with type 1 diabetes during a 16-day wear period.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: i-SENS, Inc. (Industry-sponsored)
• Locations: 4 sites (Escondido, California and 3 other locations)
• Trial ID: NCT07296276 on ClinicalTrials.gov

What this trial studies

Adults with type 1 diabetes will wear two CareSens Air 3 sensors and one Libre 3 Plus for 16 days while continuing their usual insulin regimen and without access to CareSens Air 3 readings. Participants will perform at least eight capillary blood glucose checks per day using SMBG and will attend four clinic visits for controlled reference measurements, including induced low and high glucose conditions. The Libre 3 Plus and capillary blood samples will serve as reference comparators to quantify the accuracy and precision of the CareSens Air 3. The trial is an open-label, single-arm pilot designed to generate performance data for the device.

Who should consider this trial

Good fit: Adults aged 18–65 with type 1 diabetes on intensive insulin therapy (MDI or insulin pump), willing to wear multiple CGM sensors, perform frequent fingersticks, and attend four clinic visits during the 16-day period are ideal candidates.

Not a fit: Patients with severe skin conditions at the sensor site, known allergic contact dermatitis to medical adhesives, a recent history of severe hypoglycemia, or inability to perform frequent fingerstick testing are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the CareSens Air 3 could provide reliable continuous glucose readings that help people with type 1 diabetes manage insulin dosing more safely and effectively.

How similar studies have performed: Multiple prior studies have validated other CGM systems (for example FreeStyle Libre and Dexcom) using similar head-to-head and capillary reference methods, though the CareSens Air 3 itself is being newly tested here.

Eligibility criteria

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.

Where this trial is running

Escondido, California and 3 other locations

• Headlands Research AMCR — Escondido, California, United States (Not_yet_recruiting)
• Diablo Clinical Research — Walnut Creek, California, United States (Recruiting)
• Atlanta Diabetes Associates — Atlanta, Georgia, United States (Not_yet_recruiting)
• Rainier Clinical Reseach Center — Renton, Washington, United States (Recruiting)

Conditions Type 1 Diabetes Mellitus