Overview
- Medical device study evaluating the use of a technology platform (smartphone app) to evaluate heart rate through fingertips
- Study protocol required that 30% of the total enrollment (85) be subjects with a skin type of Fitzpatrick V or VI (brown and black skin tones)
Problem
- Accurate fingertip readings can be more challenging with subjects of a darker skin tone
Solution
- TOTAL identified seven sites that had immediate access to subjects who would meet the Fitzpatrick V and VI skin types
- Enrollment was stratified where the Fitzpatrick V and VI subjects were enrolled first and then the remainder of enrollment for all other skin types was opened to finish complete enrollment
Results
- Study enrolled three weeks early
- 33 of the 26 required Fitzpatrick V and VI subjects was enrolled
- Exceeded diversity goal by 27%
