Point-of-Care Testing in Outpatient Diabetes Care

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06684990

Enrollment

222

Registered

2024-11-12

Start date

2025-01-02

Completion date

2028-04-30

Last updated

2025-09-11

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

Conditions

Diabetes

Keywords

Diabetes, HbA1c, cystatin C, point of care

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.

Interventions

OTHERPOC testing

POC testing for HbA1c and cystatin C

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Intervention model description

The investigators will conduct POC testing for HbA1c and cystain C in outpatients with diabetes, and present the results to their providers. Follow up data on fasting glucose, HbA1c, serum creatinine, urine albumin to creatinine ratio (UACR), lipids profile, ...etc will be collected every 6 months for 3 years. Patients who decline to POC testing but provide consent to observational follow up will serve as the controls. The investigators will examine the effects of POC testing on changes in glycemic control and renal function in study participants.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

1. 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. 2. Chronic liver disease, cirrhosis, hyperbilirubinemia, asplenia (splenomegaly, splenectomy). 3. Hypertriglyceridemia (over 500 mg/dl), or alcoholism. 4. Thyroid dysfunction, active malignant tumors under treatment, HIV infection. 5. Long-term use (over three months) of steroids or cyclosporine. 6. Severe proteinuria (e.g., nephrotic syndrome), or a baseline eGFR \<60 ml/min/1.73 m².

Design outcomes

Primary

Measure	Time frame	Description
Changes from baseline to the end of study in eGFR	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

Measure	Time frame
Changes from baseline to the end of study in UACR	Observational follow up period of 3 years

Other

Measure	Time frame	Description
Incident chronic kidney disease	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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026