Cardiometabolic Devices Accuracy Study

NCT05257564 | Completed

• 1 other identifier: NC001
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Diabetes Mellitus; Chronic Kidney Diseases; Hyperlipidemias

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 months

Secondary Outcomes (4)

• Operational characteristics of study device Tascom

  4 months

• Operational characteristics of study device JanaCare

  4 months

• Usability of study devices Tascom

  4 months

• Usability of study devices JanaCare

  4 months

Study Arms (1)

Diagnostic

OTHER

Fingerstick collection and venous whole blood collection.

Device: Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche)

Interventions

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.

Diagnostic

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• University Hospital, Geneva: collaborator
• B.P. Koirala Institute of Health Sciences: collaborator

Study Sites (1)

B.P Koirala Institute of Health Sciences

Dharān, Sunsari, 56700, Nepal

Location

Related Publications (1)

• 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.

  PMID: 39361597 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic; Hyperlipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Sanjib Sharma, Prof.Dr

  head of the B.P Koirala Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective quantitative accuracy study

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 25, 2022
• Study Start: February 14, 2022
• Primary Completion: May 29, 2022
• Study Completion: June 30, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)