Status:

COMPLETED

Cardiometabolic Devices Accuracy Study

Lead Sponsor:

Foundation for Innovative New Diagnostics, Switzerland

Collaborating Sponsors:

University Hospital, Geneva

B.P. Koirala Institute of Health Sciences

Conditions:

Diabetes Mellitus

Chronic Kidney Diseases

Eligibility:

All Genders

20+ years

Phase:

NA

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 (L...

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 o...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

February 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2022

Estimated Enrollment :

359 Patients enrolled

Trial Details

Trial ID

NCT05257564

Start Date

February 14 2022

End Date

June 30 2022

Last Update

March 20 2024

Active Locations (1)

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B.P Koirala Institute of Health Sciences

Dharān, Sunsari, Nepal, 56700