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OpenTrials
Active, Not Recruiting

NCT Number: NCT06684990

Point-of-Care Testing in Outpatient Diabetes Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

POC testing

Other

POC testing for HbA1c and cystatin C

Primary outcomes

  1. 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

  1. Changes from baseline to the end of study in UACR

    Time frame: Observational follow up period of 3 years

Other outcomes

  1. Incident chronic kidney disease

    Time frame: Observational follow up period of 3 years

    incident chronic kidney disease is defined as an eGFR <60 ml/min/1.73 m2 of at least 3 months duration.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 12, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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