Human Factors Research Applied: The Development of a Personal Touch Screen Insulin Pump and Users' Perceptions of Actual Use

Abstract Background: A brief history of the field of human factors research is covered, along with how this discipline is leveraged within medical device companies, to eliminate design flaws in products, in order to make them safe and effective for human use. The way in which human factors research was used to develop the t:slim® insulin delivery system (Tandem Diabetes Care® Inc., San Diego, CA) is also discussed. Following the development of the t:slim pump, a product evaluation study was conducted to assess users' perceptions of the t:slim pump under actual use conditions versus their current pump system. Subjects and Methods: A 30-day, within-subjects study with a total of 74 participants was conducted at four different investigator sites across the United States. Study participants used the t:slim insulin pump in their normal environment for 30 days. Participants were given the Insulin Delivery System Rating Questionnaire during their first visit to assess their current insulin pump and then at the e...