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A real world study of remote continuous noninvasive monitoring and diagnosis of diabetic kidney disease using a two dimensional heterostructure based wearable NH₃ sensor

NCT ID NCT07888855

Sponsor: Shanghai Pudong Hospital Source: ClinicalTrials.gov ↗

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This trial is taking on new participants right now.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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

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First seen Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time

Summary

This retrospective study evaluates whether providing clinicians with artificial intelligence (AI)-based kidney function results from a breath ammonia test can improve the quality of medication recommendations made by clinical pharmacists. Using historical inpatient cases from Shanghai Pudong Hospital, each case was evaluated under two information conditions: one with standard clinical information only, and one with the additional AI-based breath test kidney function results. Independent experts blindly scored the medication recommendations. The study aims to determine whether the breath test AI information adds meaningful clinical value to pharmacist decision-making.

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 380 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Aug 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 study population consists of historical inpatient cases who previously underwent breath ammonia testing and received AI-based kidney function classification results at Shanghai Pudong Hospital. Eligible cases had complete standardized clinical records from the breath test hospitalization, with serum creatinine and eGFR results available within 7 days of the breath test serving as an independent reference standard. These de-identified cases represent patients with diabetes and/or kidney disease in real-world inpatient settings, used to evaluate the impact of AI-assisted breath ammonia information on clinical pharmacist medication recommendations.

Ages

18 years and older

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: * Historical cases with completed breath test and AI kidney function classification results. * Complete standardized case records from the breath test hospitalization. * Serum creatinine and eGFR results available within 7 days before or after the breath test, serving as an independent reference standard. * Case data sufficient to support the pharmacist in making medication recommendations. Exclusion Criteria: * Missing standardized case data preventing independent medication evaluation. * Breath test and reference blood test interval exceeding 7 days. * Case in acute kidney injury (AKI) state. * Cases that cannot maintain information isolation between Condition A and Condition B.

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Conditions

The condition(s) this trial relates to.

diabetic kidney disease type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus, type 2 Diabetic nephropathies

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

    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

  • Shanghai Pudong Hospital

    Shanghai, China

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