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A simple saliva test could revolutionize diabetes monitoring

NCT ID NCT07781683

Diagnosis Sponsor: Shanghai 6th People's Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study is testing whether a new saliva-based test can accurately measure a key marker of blood sugar control called 1,5-anhydroglucitol (1,5-AG). The researchers will compare saliva levels with blood levels and continuous glucose monitor data in 180 adults with and without type 2 diabetes. If saliva 1,5-AG proves reliable, it could offer a painless, convenient alternative to finger-prick blood tests for managing diabetes.

What this could mean

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

Active substance
Salivary 1,5-anhydroglucitol (1,5-AG) detection technology
What this could lead to
If successful, this could lead to a painless, noninvasive way to monitor blood sugar control in people with type 2 diabetes, potentially replacing frequent blood tests.
What could go wrong
This is an observational study, so it won't prove the test improves outcomes. The accuracy of saliva measurements may vary, and more research will be needed before it can be used in clinics.

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.

Participants

About 180 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.

Ages

18 to 80 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: 1. Aged between 18 and 80 years. 2. Individuals without a history of diabetes, or patients with type 2 diabetes mellitus. Exclusion Criteria: 1. History of systemic glucocorticoid treatment within the previous 6 weeks. 2. Presence of acute infection. 3. Presence of severe oral conditions that may affect saliva collection or measurement. 4. Presence of severe hepatic or renal dysfunction. 5. History of alcohol abuse or psychiatric disorders, including depression. 6. Current treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes (T2DM)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233, China

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