Diabetes MellitusNCT05257564
Cardiometabolic Devices Accuracy Study
A study testing Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche) in people with Diabetes Mellitus and Chronic Kidney Diseases, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Nepal.
Trial summary
With the rise of cardiovascular diseases (CVD) and diabetes, the global disease burden is shifting towards non-communicable diseases (NCDs). An increasing number of low- and middle-income countries (LMICs) are currently experiencing the double burden of infectious and non-communicable diseases. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Chronic Kidney Diseases, Hyperlipidemias
- What is being tested?
- Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 359 participants
- Where
- 1 siteNepal
- Study dates
- 14 Feb 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 years or older (in line with KHDC eligibility age)
- Attending the Dhulabari PHC facility or Kakarvitta health post in the context of the KHDC program
- Haemoglobin levels ≥8 g/dL
- Able and willing to provide informed consent
Who cannot join
- Inability to provide sufficient capillary or venous whole blood sample for all tests
- Haemoglobin levels < 8g/dL
- Anyone attending the Dhulabari PHC facility or Kakarvitta health post for other reasons than the KHDC program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance and Usability Evaluation of Cardiometabolic Point-of-care Devices in a Target Use Setting
With the rise of cardiovascular diseases (CVD) and diabetes, the global disease burden is shifting towards non-communicable diseases (NCDs). An increasing number of low- and middle-income countries (LMICs) are currently experiencing the double burden of infectious and non-communicable diseases. In order to facilitate a patient-centred approach to healthcare, there is an urgent need to ensure that primary healthcare (PHC) facilities in LMICs are capable of addressing diagnosis and monitoring of non-communicable diseases at the point-of-care (POC). Important minimum parameters for PHC POC diagnosis and monitoring of cardiometabolic diseases are lipids/lipoproteins, glucose, glycated haemoglobin (HbA1c) and serum creatinine, to address cardiovascular disease, diabetes and chronic kidney disease.
While several technologies of multi-parameter POC devices capable of supporting diagnosis and monitoring of cardiometabolic diseases exist, their quantitative accuracy is often not well evaluated outside of the manufacturer's laboratories and published independent evaluations can be rare, particularly in the settings of intended use. These settings are PHC facilities in varying climatic environments and with staff without specialist laboratory training. Our study aims to evaluate the quantitative accuracy of 2 cardiometabolic POC devices in a setting of intended use and performed by the intended user. (Evaluating the quantitative measurements of glucose, HbA1c, total cholesterol and creatinine as measured in a healthcare setting with point-of-care multiparameter devices compared to a laboratory reference method).
Read the detailed description
Independent performance evaluation of POC devices have shown that many devices, regardless of their intended use, do not perform as well as the manufacturers' claims may suggest. There are a variety of reasons for this, including difference in skills levels of personnel who were involved in generating the data for the manufacturer's claims and who actually perform the test in a clinic, limited evaluation of samples from different geographical locations and thus potential interfering substances or less controlled environmental conditions (e.g. dust, heat and humidity).
Independent performance evaluations to assess clinical accuracy, as well as system usability are important to drive adoption of any technology, and even more so, if the technology is intended to move testing outside of the traditional setting, i.e. away from the central laboratory to the point-of-care. Many devices appear ideally suited for certain settings, however when it comes to actual implementation, the users often discover that the device and workflow do not meet their needs. The choice of a suboptimal device means badly invested resources and may lead to inappropriate use, resulting in fewer reliable tests for patients in the absence of alternatives. Data from real-world evaluations in settings of the intended use can support decision makers to select the right device.
The setting for this study will be a primary healthcare facility and a health post in Nepal, where study participants attend the facility in the context of the "Early detection and management of Chronic Kidney Diseases, Hypertension, Diabetes and Cardiovascular disease in Community in Nepal (KHDC-Nepal) program", conducted by the University Hospital of Geneva and the BP Koirala Institute of Health Science in Nepal.
- Conditions
- Diabetes Mellitus, Chronic Kidney Diseases, Hyperlipidemias
- Being tested
- Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche)
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche)Device
Fingerstick capillary blood will be collected according to each manufacturer's Instructions for use. The fingerstick capillary blood samples will be used immediately on the point-of-care assays. The venous blood will be collected in specific tubes for plasma (GLU), for whole blood (HbA1c) and for serum (CREP, CHOL). Plasma will be separated by centrifugation at the PHC facility and health post and aliquots will be prepared. Serum will be left to clot prior to centrifugation and serum aliquots will be prepared at the PHC facility and health post. The samples will be stored until transfer to the BPKIHS reference lab.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Other | Fingerstick collection and venous whole blood collection. Receives: Device: Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation estimation of quantitative measurements of cardiometabolic blood parameters measured on a point-of-care device versus a laboratory reference method
Estimates of correlation between quantitative measurements of blood glucose, HbA1c, total cholesterol and creatinine collected from capillary blood and tested with point-of-care multiparameter devices versus quantitative measurements of blood glucose, HbA1c, total cholesterol and creatinine collected from venous blood and tested with a laboratory reference method.
Measured: 4 months
Limits of agreements estimation of quantitative measurements of cardiometabolic blood parameters measured on a point-of-care device versus a laboratory reference method
Estimates of limits of agreement for quantitative measurements of blood glucose, HbA1c, total cholesterol and creatinine collected from capillary blood and tested with point-of-care multiparameter devices versus quantitative measurements of blood glucose, HbA1c, total cholesterol and creatinine collected from venous blood and tested with a laboratory reference method.
Measured: 4 months
Secondary outcomes (4)
Operational characteristics of study device Tascom
Rate of invalid test results and error types for Tascom (POC device)
Measured: 4 months
Operational characteristics of study device JanaCare
Rate of invalid test results and error types for JanaCare(POC device)
Measured: 4 months
Usability of study devices Tascom
System usability score for Tascom (POC device) SUS Score (>80.3, Grade A, Excellent) SUS Score (68-80.3, Grade B, Good) SUS Score (68, Grade C, Okay) SUS Score (51-68, Grade D, Poor) SUS Score (<51, Grade F, Awful)
Measured: 4 months
Usability of study devices JanaCare
System usability score for JanaCare(POC device) SUS Score (>80.3, Grade A, Excellent) SUS Score (68-80.3, Grade B, Good) SUS Score (68, Grade C, Okay) SUS Score (51-68, Grade D, Poor) SUS Score (<51, Grade F, Awful)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start14 Feb 2022
- Primary completion29 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective quantitative accuracy study
- Masking
- None (open label)
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, B.P. Koirala Institute of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Sanjib Sharma, Prof.Dr, Principal investigator, head of the B.P Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257564
- Sponsor's protocol ID
- NC001
- Status last verified
- Mar 2024
- First submitted
- 28 Jan 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giachino M, Vetter B, Perone SA, Correia JC, Erkosar B, Heller O, Khanal VK, Lab B, Pataky Z, Poudel S, Rai M, Sharma SK. Performance and usability of cardiometabolic point of care devices in Nepal: A prospective, quantitative, accuracy study. PLOS Glob Public Health. 2024 Oct 3;4(10):e0003760. doi: 10.1371/journal.pgph.0003760. eCollection 2024.
PubMed 39361597
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Usability Evaluation of Cardiometabolic Point-of-care Devices in a Target Use Setting
- ClinicalTrials.gov ID
- NCT05257564
- Acronym / sponsor ID
- NC001
- Conditions
- Diabetes Mellitus, Chronic Kidney Diseases, Hyperlipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, B.P. Koirala Institute of Health Sciences
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 29 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Feb 2022 (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.
With the rise of cardiovascular diseases (CVD) and diabetes, the global disease burden is shifting towards non-communicable diseases (NCDs). An increasing number of low- and middle-income countries (LMICs) are currently experiencing the double burden of infectious and non-communicable diseases. In order to facilitate a patient-centred approach to healthcare, there is an urgent need to ensure that primary healthcare (PHC) facilities in LMICs are capable of addressing diagnosis and monitoring of non-communicable diseases at the point-of-care (POC). Important minimum parameters for PHC POC diagnosis and monitoring of cardiometabolic diseases are lipids/lipoproteins, glucose, glycated haemoglobin (HbA1c) and serum creatinine, to address cardiovascular disease, diabetes and chronic kidney disease.
While several technologies of multi-parameter POC devices capable of supporting diagnosis and monitoring of cardiometabolic diseases exist, their quantitative accuracy is often not well evaluated outside of the manufacturer's laboratories and published independent evaluations can be rare, particularly in the settings of intended use. These settings are PHC facilities in varying climatic environments and with staff without specialist laboratory training. Our study aims to evaluate the quantitative accuracy of 2 cardiometabolic POC devices in a setting of intended use and performed by the intended user. (Evaluating the quantitative measurements of glucose, HbA1c, total cholesterol and creatinine as measured in a healthcare setting with point-of-care multiparameter devices compared to a laboratory reference method).
Detailed description
Independent performance evaluation of POC devices have shown that many devices, regardless of their intended use, do not perform as well as the manufacturers' claims may suggest. There are a variety of reasons for this, including difference in skills levels of personnel who were involved in generating the data for the manufacturer's claims and who actually perform the test in a clinic, limited evaluation of samples from different geographical locations and thus potential interfering substances or less controlled environmental conditions (e.g. dust, heat and humidity).
Independent performance evaluations to assess clinical accuracy, as well as system usability are important to drive adoption of any technology, and even more so, if the technology is intended to move testing outside of the traditional setting, i.e. away from the central laboratory to the point-of-care. Many devices appear ideally suited for certain settings, however when it comes to actual implementation, the users often discover that the device and workflow do not meet their needs. The choice of a suboptimal device means badly invested resources and may lead to inappropriate use, resulting in fewer reliable tests for patients in the absence of alternatives. Data from real-world evaluations in settings of the intended use can support decision makers to select the right device.
The setting for this study will be a primary healthcare facility and a health post in Nepal, where study participants attend the facility in the context of the "Early detection and management of Chronic Kidney Diseases, Hypertension, Diabetes and Cardiovascular disease in Community in Nepal (KHDC-Nepal) program", conducted by the University Hospital of Geneva and the BP Koirala Institute of Health Science in Nepal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective quantitative accuracy study
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Other | Device: Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche)Fingerstick collection and venous whole blood collection. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 years or older (in line with KHDC eligibility age)
- Attending the Dhulabari PHC facility or Kakarvitta health post in the context of the KHDC program
- Haemoglobin levels ≥8 g/dL
- Able and willing to provide informed consent
Key exclusion criteria (3 listed)
- Inability to provide sufficient capillary or venous whole blood sample for all tests
- Haemoglobin levels < 8g/dL
- Anyone attending the Dhulabari PHC facility or Kakarvitta health post for other reasons than the KHDC program
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 |
|---|---|---|
| Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche)Fingerstick capillary blood will be collected according to each manufacturer's Instructions for use. The fingerstick capillary blood samples will be used immediately on the point-of-care assays. The venous blood will be collected in specific tubes for plasma (GLU), for whole blood (HbA1c) and for serum (CREP, CHOL). Plasma will be separated by centrifugation at the PHC facility and health post and aliquots will be prepared. Serum will be left to clot prior to centrifugation and serum aliquots will be prepared at the PHC facility and health post. The samples will be stored until transfer to the BPKIHS reference lab. | Device | Diagnostic |
Primary outcome
Correlation estimation of quantitative measurements of cardiometabolic blood parameters measured on a point-of-care device versus a laboratory reference method
Time frame: 4 months
Estimates of correlation between quantitative measurements of blood glucose, HbA1c, total cholesterol and creatinine collected from capillary blood and tested with point-of-care multiparameter devices versus quantitative measurements of blood glucose, HbA1c, total cholesterol and creatinine collected from venous blood and tested with a laboratory reference method.
Limits of agreements estimation of quantitative measurements of cardiometabolic blood parameters measured on a point-of-care device versus a laboratory reference method
Time frame: 4 months
Estimates of limits of agreement for quantitative measurements of blood glucose, HbA1c, total cholesterol and creatinine collected from capillary blood and tested with point-of-care multiparameter devices versus quantitative measurements of blood glucose, HbA1c, total cholesterol and creatinine collected from venous blood and tested with a laboratory reference method.
4 secondary outcomes
Operational characteristics of study device Tascom
Time frame: 4 months
Operational characteristics of study device JanaCare
Time frame: 4 months
Usability of study devices Tascom
Time frame: 4 months
Usability of study devices JanaCare
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 39361597Giachino M, Vetter B, Perone SA, Correia JC, Erkosar B, Heller O, Khanal VK, Lab B, Pataky Z, Poudel S, Rai M, Sharma SK. Performance and usability of cardiometabolic point of care devices in Nepal: A prospective, quantitative, accuracy study. PLOS Glob Public Health. 2024 Oct 3;4(10):e0003760. doi: 10.1371/journal.pgph.0003760. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Sanjib Sharma, Prof.Dr principal investigator
head of the B.P Koirala Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche) in people with Diabetes Mellitus and Chronic Kidney Diseases, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Nepal.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 20 Mar 2024. 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 Nepal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation estimation of quantitative measurements of cardiometabolic blood parameters measured on a point-of-care device versus a laboratory reference method (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05257564, which also lists 1 linked publication.
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 20 Mar 2024.