External validation of the 1-DKA alert for differentiating diabetic ketoacidosis from simple hyperglycemia in patients with high blood glucose

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20251003006

Enrollment

287

Registered

2025-10-03

Start date

2024-09-26

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

External validation of the 1-DKA alert for differentiating diabetic ketoacidosis from simple hyperglycemia in patients with high blood glucose Diabetic Ketoacidosis, Hyperglycemia, Clinical Prediction Rules, Diagnosis, Mobile Applications, Diabetes Mellitus, ADA guidelines 2024

Interventions

Adult patients presenting with hyperglycemia who underwent evaluation by the 1-DKA alert and DKA laboratory criteria including blood glucose, serum ketone, venous blood gas, serum creatinine, and seru

Diagnostic

Patients with hyperglycemia

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age greater than or equal to 18 years 2. Capillary blood glucose CBG or blood sugar level greater than 200 mg per dL 3. Confirmed diagnosis of DKA by laboratory test set

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. HHS (Hyperosmotic hyperglycemic state)

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of the 1-DKA alert At initial emergency department presentation Comparison of 1-DKA alert output with ADA 2024 laboratory confirmed DKA diagnosis	—

Secondary

Measure	Time frame
AUROC of 1-DKA alert At index emergency department visit Receiver operating characteristic analysis against reference DKA diagnosis,Calibration performance At index emergency department visit Agreement between predicted DKA probability and observed diagnosis; reported by calibration slope and CITL,Observed to expected ratio At index emergency department visit Ratio of observed DKA cases to expected cases from the 1-DKA alert predictions,Confusion matrix results At index emergency department visit Sensitivity, specificity, positive predictive value and negative predictive value of the 1-DKA alert,Decision curve analysis At index emergency department visit Net benefit of the 1-DKA alert across clinically relevant probability thresholds	—

Measure

Time frame

AUROC of 1-DKA alert At index emergency department visit Receiver operating characteristic analysis against reference DKA diagnosis,Calibration performance At index emergency department visit Agreement between predicted DKA probability and observed diagnosis; reported by calibration slope and CITL,Observed to expected ratio At index emergency department visit Ratio of observed DKA cases to expected cases from the 1-DKA alert predictions,Confusion matrix results At index emergency department visit Sensitivity, specificity, positive predictive value and negative predictive value of the 1-DKA alert,Decision curve analysis At index emergency department visit Net benefit of the 1-DKA alert across clinically relevant probability thresholds

—

Countries

Thailand

Contacts

Public ContactRateemutthana Promsombut

Department of Emergency Medicine, Lampang Hospital

prateemutthana@gmail.com0862794424

Outcome results

None listed

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