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Clinical Trials/NCT06684990
NCT06684990
Active, not recruiting
Not Applicable

Evaluation of a Fast Point-of-care Platform for Diabetes Care at Out-patient Clinics

Taichung Veterans General Hospital1 site in 1 country222 target enrollmentJanuary 2, 2025
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Taichung Veterans General Hospital
Enrollment
222
Locations
1
Primary Endpoint
Changes from baseline to the end of study in eGFR
Status
Active, not recruiting
Last Updated
7 months ago

Overview

Brief Summary

Using a point-of-care (POC) platform, the investigators will investigate the effects of POC testing for glycated hemoglobin (HbA1c) and cystatin C at out-patient clinics on long-term diabetes outcomes.

Detailed Description

Laboratory testing for HbA1c and cystatin C is time-consuming, and healthcare providers often do not have update results when they evaluate outpatients with diabetes. A POC testing platform may help address this issue, and the investigators aim to examine its effects on diabetes outcomes.

Registry
clinicaltrials.gov
Start Date
January 2, 2025
End Date
April 1, 2028
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jun-Sing Wang, MD, PhD

Director, Division of Endocrinology and Metabolism

Taichung Veterans General Hospital

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 80 receiving treatment and follow-up for diabetes at outpatient clinics of Taichung Veterans General Hospital, Taichung, Taiwan.

Exclusion Criteria

  • Past medical history of hemolytic anemia, hemoglobinopathies (sickle cell anemia HbS, fetal hemoglobin HbF), iron deficiency anemia, thalassemia, pernicious anemia, recent blood transfusions, acute bleeding requiring erythropoiesis-stimulating agents.
  • Chronic liver disease, cirrhosis, hyperbilirubinemia, asplenia (splenomegaly, splenectomy).
  • Hypertriglyceridemia (over 500 mg/dl), or alcoholism.
  • Thyroid dysfunction, active malignant tumors under treatment, HIV infection.
  • Long-term use (over three months) of steroids or cyclosporine.
  • Severe proteinuria (e.g., nephrotic syndrome), or a baseline eGFR \<60 ml/min/1.73 m².

Outcomes

Primary Outcomes

Changes from baseline to the end of study in eGFR

Time Frame: Observational follow up period of 3 years

Estimated glomerular filtration rate (eGFR) will be determined using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey AS, et al. Ann Intern Med. 2009; 150: 604-12).

Secondary Outcomes

  • Changes from baseline to the end of study in UACR(Observational follow up period of 3 years)

Study Sites (1)

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