DiabetesNCT06684990
Point-of-Care Testing in Outpatient Diabetes Care
A study testing POC testing in people with Diabetes, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- POC testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jan 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Adults aged 18 to 80 receiving treatment and follow-up for diabetes at outpatient clinics of Taichung Veterans General Hospital, Taichung, Taiwan.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Fast Point-of-care Platform for Diabetes Care at Out-patient Clinics
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- POC testing
- Keywords
- Diabetes, HbA1c, cystatin C, point of care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC testingOther
POC testing for HbA1c and cystatin C
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Observational follow up period of 3 years
Secondary outcomes (1)
Changes from baseline to the end of study in UACR
Measured: Observational follow up period of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start2 Jan 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Sing Wang, MD, PhD, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684990
- Sponsor's protocol ID
- CE24395C
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Fast Point-of-care Platform for Diabetes Care at Out-patient Clinics
- ClinicalTrials.gov ID
- NCT06684990
- Acronym / sponsor ID
- CE24395C
- Conditions
- Diabetes
- Keywords
- Diabetes, HbA1c, cystatin C, point of care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Outpatients with diabetes who provide consent to POC testing | Experimental | Other: POC testingIntervention: 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Adults aged 18 to 80 receiving treatment and follow-up for diabetes at outpatient clinics of Taichung Veterans General Hospital, Taichung, Taiwan.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POC testingPOC testing for HbA1c and cystatin C | Other | Outpatients with diabetes who provide consent to POC testing |
Primary outcome
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).
1 secondary outcome
Changes from baseline to the end of study in UACR
Time frame: Observational follow up period of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Undecided. Data will be available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POC testing in people with Diabetes, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline to the end of study in eGFR (time frame: Observational follow up period of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.