Recruiting

CareSens Air 3

Sponsor:

i-SENS, Inc.

Code:

NCT07296276

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

CareSens Air 3 primary insertion

CareSens Air 3 secondary insertion

Study Details

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

Study ID

NCT07296276

Start date

Feb 9, 2026

Status verified date

Feb, 2026

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CareSens Air 3 primary insertion site

CareSens Air 3 primary insertion site

experimental: CareSens Air 3 secondary insertion site

CareSens Air 3 secondary insertion site

Interventions

CareSens Air 3 primary insertion

Primary CareSens Air 3 device

CareSens Air 3 secondary insertion

Secondary CareSens Air 3 device

Primary outcome measure

  • Accuracy of the glucose concentration measurements [ Time Frame: 16 days ]

Central Contacts and Locations

Locations

Diablo Clinical Research

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Principal Investigator, MD

925-930-7267Mchristiansen@flourishresearch.com

Rainier Clinical Reseach Center

Recruiting

Renton, Washington, United States, 98057

Contacts

Principal Investigator, MD

425-251-1720SMarks@rainier-research.com

More Information

Sponsor

i-SENS, Inc.

Last update posted

Apr 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by i-SENS, Inc. on 2026-04-09.