Point-of-Care Testing in Outpatient Diabetes Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Outpatients with diabetes who provide consent to POC testing

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.

Group Type EXPERIMENTAL

POC testing

Intervention Type OTHER

POC testing for HbA1c and cystatin C

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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POC testing

POC testing for HbA1c and cystatin C

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No