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New blood sugar monitor put to the test in type 1 diabetes trial

NCT ID NCT07296276

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing how well a new continuous glucose monitor, called CareSens Air 3, measures blood sugar levels in adults with type 1 diabetes. Researchers will compare the monitor's readings to standard lab measurements. The goal is to see if the device is accurate and precise enough for everyday use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CareSens Air 3 continuous glucose monitoring system
What this could lead to
If successful, this could provide a more accurate and reliable way for people with type 1 diabetes to monitor their blood sugar levels.
What could go wrong
This is a small, early pilot study with only 32 participants, so results may not apply to everyone. The device may not be as accurate as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta Diabetes Associates

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30318, United States

  • Diablo Clinical Research

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Headlands Research AMCR

    NOT_YET_RECRUITING

    Escondido, California, 92025, United States

  • Rainier Clinical Reseach Center

    RECRUITING

    Renton, Washington, 98057, United States

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