An observational study in Diabetes Mellitus, Type 2 and Diabetic Nephropathies, sponsored by Shanghai Pudong Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Shanghai Pudong Hospital · Observational
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 380 is above the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Shanghai Pudong Hospital is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
De-identified standardized case summaries provided to clinical pharmacists without real serum creatinine and eGFR results and without breath test AI output. Approximately 380 cases.
Identical standardized case summaries as Condition A, with the addition of breath test AI kidney function results (estimated renal function, CKD stage probability, and confidence), while real serum creatinine and eGFR remain blinded. Approximately 380 cases.
Decision Score Difference Between Information Conditions
Adjusted mean difference in the composite medication recommendation score (0-40 scale) between Condition A and Condition B for the same cases, with 95% confidence interval.
Time frame: up to 4 weeks
Proportion of Correct Decisions
Proportion of cases where the medication recommendation is rated correct and reasonable, compared between Condition A and Condition B.
Time frame: up to 4 weeks
Recommendation Consistency Rate
Proportion of pharmacist-recommended treatment plans consistent with gold standard and expert consensus.
Time frame: up to 4 weeks
Unreasonable Recommendation Rate
Proportion of cases containing principle errors (e.g., recommending nephrotoxic drugs despite declined renal function, dosing errors).
Time frame: up to 4 weeks
Decision Confidence
Difference in self-reported decision confidence scores (0-10 scale) between Condition A and Condition B.
Time frame: up to 4 weeks
Decision Time
Difference in time taken to complete medication recommendations between Condition A and Condition B.
Time frame: up to 4 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified standardized case summaries and AI-assisted decision outcome data will be made available for research purposes, consistent with the study's data protection and confidentiality requirements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Beginning 12 months after the primary results publication, for a period as specified in the data sharing agreement.
Access criteria: Researchers who submit a methodologically sound proposal, subject to approval and a data use agreement; data must be used for research purposes only.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Pudong Hospital