Type 1 Diabetes MellitusAir3PilotNCT07296276
Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM
A study testing CareSens Air 3 primary insertion and CareSens Air 3 secondary insertion in people with Type 1 Diabetes Mellitus, run by i-SENS, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CareSens Air 3 primary insertion and CareSens Air 3 secondary insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Feb 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Amanda Maxson Clinical Research Manager, RN, 404-355-4393
- Not yet recruiting
Headlands Research AMCR
Escondido, California, 92025
Site Director, 760-466-1523, Laura.Bedolla@Headlandsresearchamcr.com
- Recruiting
Rainier Clinical Reseach Center
Renton, Washington, 98057
Principal Investigator, MD, 425-251-1720, SMarks@rainier-research.com
- Recruiting
Diablo Clinical Research
Walnut Creek, California, 94598
Principal Investigator, MD, 925-930-7267, Mchristiansen@flourishresearch.com
About this study
Official title: 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 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.
Read the detailed description
Participants will wear two CareSens Air 3 and one Libre 3 Plus for 16 days without access to glucose values from the CareSens Air 3 devices while maintaining their original diabetes mellitus treatment. The participants will draw capillary blood at least 8 times a day using the SMBG system between study visits.
Between insertion and removal of the CareSens Air 3 the participants will be in the clinic 4 times to obtain accurate glucose reading from the reference device under carefully controlled circumstances including induction of low and high blood glucose.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- CareSens Air 3 primary insertion, CareSens Air 3 secondary insertion
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareSens Air 3 primary insertionDevice
Primary CareSens Air 3 device
CareSens Air 3 secondary insertionDevice
Secondary CareSens Air 3 device
| Study group | Role | What they receive |
|---|---|---|
| CareSens Air 3 primary insertion site | Experimental | CareSens Air 3 primary insertion site Receives: Device: CareSens Air 3 primary insertion |
| CareSens Air 3 secondary insertion site | Experimental | CareSens Air 3 secondary insertion site Receives: Device: CareSens Air 3 secondary insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 days
Secondary outcomes (1)
Precision of the glucose measurements
Precision (absolute relative difference between simultaneous measurements between two CGM devices)
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start9 Feb 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Induction of low and high blood glucose.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- i-SENS, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrated Medical Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296276
- Sponsor's protocol ID
- CGM-008A-P102
- Acronym
- Air3Pilot
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The plan is to publish the results, but to keep the individual data proprietary.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07296276
- Acronym / sponsor ID
- Air3Pilot / CGM-008A-P102
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- i-SENS, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Integrated Medical Development
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will wear two CareSens Air 3 and one Libre 3 Plus for 16 days without access to glucose values from the CareSens Air 3 devices while maintaining their original diabetes mellitus treatment. The participants will draw capillary blood at least 8 times a day using the SMBG system between study visits.
Between insertion and removal of the CareSens Air 3 the participants will be in the clinic 4 times to obtain accurate glucose reading from the reference device under carefully controlled circumstances including induction of low and high blood glucose.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Induction of low and high blood glucose.
| Arm | Type | Receives |
|---|---|---|
| CareSens Air 3 primary insertion site | Experimental | Device: CareSens Air 3 primary insertionCareSens Air 3 primary insertion site |
| CareSens Air 3 secondary insertion site | Experimental | Device: CareSens Air 3 secondary insertionCareSens Air 3 secondary insertion site |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CareSens Air 3 primary insertionPrimary CareSens Air 3 device | Device | CareSens Air 3 primary insertion site |
| CareSens Air 3 secondary insertionSecondary CareSens Air 3 device | Device | CareSens Air 3 secondary insertion site |
Primary outcome
Accuracy of the glucose concentration measurements
Time frame: 16 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
1 secondary outcome
Precision of the glucose measurements
Time frame: 16 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No. The plan is to publish the results, but to keep the individual data proprietary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareSens Air 3 primary insertion and CareSens Air 3 secondary insertion in people with Type 1 Diabetes Mellitus, run by i-SENS, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the glucose concentration measurements (time frame: 16 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.