Point-of-Care Testing in Outpatient Diabetes Care

Taichung Veterans General Hospital

Status: Active, not recruiting

Conditions: Diabetes

Treatments: Other: POC testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06684990

CE24395C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Outpatients with diabetes who provide consent to POC testing

Experimental group

Description:

Intervention: POC testing for HbA1c and cystatin C. Observational follow up: data on fasting glucose, HbA1c, serum creatinine, urine albumin to creatinine ratio (UACR), lipids profile, ...etc.

Treatment:

Other: POC testing

Outpatients with diabetes who decline to POC testing, but consent to observational follow up

No Intervention group

Description:

This group will serve as the controls. Follow up data on fasting glucose, HbA1c, serum creatinine, urine albumin to creatinine ratio (UACR), lipids profile, ...etc.