Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Pati… (NCT07296276) | Clinical Trial Compass
RecruitingNot Applicable
Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM
United States32 participantsStarted 2026-02-09
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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, tr…
What they're measuring
1
Accuracy of the glucose concentration measurements