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CareSens Air 3 Continuous Glucose Monitor for Type 1 Diabetes

This study is testing how accurate and precise the 'CareSens Air 3' continuous glucose monitoring (CGM) system is for adults with Type 1 Diabetes Mellitus. We want to see how well the CareSens Air 3 measures your blood sugar levels. You might be able to join if you are between 18 and 65 years old, have Type 1 diabetes, and use intensive insulin therapy (like multiple daily injections or an insulin pump) for at least three months. The main goal is to check the accuracy of the glucose readings over 16 days. This is a small pilot study with 32 participants.

Study design
This is a single-arm, open-label study, meaning all 32 participants will receive the CareSens Air 3 device and you and the study team will know what treatment you are getting.
What's involved
You will wear two CareSens Air 3 devices and one Libre 3 Plus for 16 days. You will also draw capillary blood at least 8 times a day and visit the clinic 4 times for blood glucose measurements.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for accuracy is measured at 16 days, which suggests the study duration for each participant is around this time.

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NCT07296276

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

Recruiting
NAAges 18–65InterventionalDiagnostic
i-SENS, Inc.
~32 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:CareSens Air 3 primary insertionCareSens Air 3 secondary insertion

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of the glucose concentration measurements
Measured over 16 days

Conditions

Type 1 Diabetes Mellitus

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

4 sites across 3 states
California2
Georgia1
Washington1

Who to contact

Principal Investigator, MD
[email protected]
925-930-7267
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Accuracy of the glucose concentration measurements16 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