Trials / Unknown
UnknownNCT06170515
BGM and HbA1c POC Device Evaluation
Performance Evaluation of Blood Glucose Meters and HbA1c Point-of-care Devices
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 910 (estimated)
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to assess analytical performance of four BGMs and four HbA1c POC devices in comparison to suitable comparator or reference methods, with the view to evaluate performance in the hands of trained users, as well as intended users who are unfamiliar with the system (lay users, for BGMs only). System usability will also be assessed for all BGMs (including lancing devices) and HbA1c devices.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | CareSens N-Eco (i-Sens), • CareSens N-Premier (i-Sens), CodeFree (SD Biosensor), GlucoNavii GDH (SD Biosensor) | BGM Test |
| DIAGNOSTIC_TEST | Affinion (Abbott), HbA1c 501 (HemoCue), A1Care (iSens), DCA Vantage (Siemens) | HbA1c Test |
Timeline
- Start date
- 2023-04-03
- Primary completion
- 2024-03-31
- Completion
- 2024-03-31
- First posted
- 2023-12-14
- Last updated
- 2023-12-14
Locations
3 sites across 3 countries: Cambodia, Colombia, Nigeria
Source: ClinicalTrials.gov record NCT06170515. Inclusion in this directory is not an endorsement.