Point-of-Care Testing in Outpatient Diabetes Care

NCT06684990 | Active Not Recruiting

• 1 other identifier: CE24395C
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Diabetes; HbA1c; cystatin C; point of care

Outcome Measures

Primary Outcomes (1)

• Changes from baseline to the end of study in eGFR

  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).

  Observational follow up period of 3 years

Secondary Outcomes (1)

• Changes from baseline to the end of study in UACR

  Observational follow up period of 3 years

Other Outcomes (1)

• Incident chronic kidney disease

  Observational follow up period of 3 years

Study Arms (2)

Outpatients with diabetes who provide consent to POC testing

EXPERIMENTAL

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.

Other: POC testing

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

NO INTERVENTION

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.

Interventions

POC testing OTHER

POC testing for HbA1c and cystatin C

Outpatients with diabetes who provide consent to POC testing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Endocrinology and Metabolism

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

TW (1)