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Subsequent Medication Use and the Risk of Ketoacidosis in Patients with SGLT2 Inhibitor-Associated Ketosis: A Real-World Cohort Study

Subsequent Medication Use and the Risk of Ketoacidosis in Patients with SGLT2 Inhibitor-Associated Ketosis: A Real-World Cohort Study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128924
Enrollment
Unknown
Registered
2026-07-28
Start date
2025-06-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Continue SGLT2i group:None
Switch to other antihyperglycemic drugs group:None

Sponsors

The Third Affiliated Hosptial of ChongQing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. We enrolled patients who visited our hospital from Jan 1, 2016 to Jun 30, 2025, with ketosis and/or ketoacidosis after SGLT2 inhibitor therapy. Diagnosis followed the 2024 ADA/EASD consensus: (1) ketosis defined as venous/capillary ß-hydroxybutyrate >=0.6 mmol/L or urine ketones >=2+; 2. DKA defined as ketosis plus metabolic acidosis (pH <7.35 and/or HCO3? <18 mmol/L).

Exclusion criteria

Exclusion criteria: 1. type 1 diabetes mellitus; 2. pregnancy-related ketosis; 3. ketosis or ketoacidosis attributable to causes other than SGLT2 inhibitor use, including alcohol intoxication, severe starvation, or hyperglycemia (plasma glucose =16.7 mmol/L) at the time of ketosis/ketoacidosis onset; 4. loss to follow-up, or absence of repeated urine or blood ketone measurements, or lack of subsequent medication records during follow-up; 5. presence of concurrent severe complications (e.g., acute pancreatitis, liver failure).

Design outcomes

Primary

MeasureTime frame
Urinary ketone;bicarbonate ion concentration in blood gas analysis;Serum ß-hydroxybutyrate;PH;

Secondary

MeasureTime frame
estimated glomerular filtration rate;serum creatinine;Urinary albumin-to-creatinine ratio;

Countries

China

Contacts

Public ContactLian Duan

The Third Affiliated Hosptial of ChongQing Medical University

jasonmao2005@163.com+86 23 6035 3431

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026