Noel E Schaeffer1. 1. Tandem Diabetes Care Inc. , San Diego, California.
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 end of the study to measure their perceptions of the t:slim pump. A paired-samples t test was completed to analyze the data. RESULTS: The results indicated that 16 of the questionnaire variables showed statistically significant differences in scores. CONCLUSIONS: It was found that the utilization of a systematic human factors process resulted in an insulin pump that was proved to be safe and effective for human use and was cleared by the Food and Drug Administration for use in the United States. In addition, the results of the product evaluation study showed that, after use of the t:slim pump for 30 days, participants' perceptions of several variables improved.
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 end of the study to measure their perceptions of the t:slim pump. A paired-samples t test was completed to analyze the data. RESULTS: The results indicated that 16 of the questionnaire variables showed statistically significant differences in scores. CONCLUSIONS: It was found that the utilization of a systematic human factors process resulted in an insulin pump that was proved to be safe and effective for human use and was cleared by the Food and Drug Administration for use in the United States. In addition, the results of the product evaluation study showed that, after use of the t:slim pump for 30 days, participants' perceptions of several variables improved.
Authors: Noel E Schaeffer; Linda J Parks; Erik T Verhoef; Timothy S Bailey; Alan B Schorr; Trent Davis; Jean Halford; Becky Sulik Journal: J Diabetes Sci Technol Date: 2014-10-14
Authors: Jasmin R Hauzenberger; Brian R Hipszer; Channy Loeum; Peter A McCue; Mark DeStefano; Marc C Torjman; Mahmut T Kaner; Alek R Dinesen; Inna Chervoneva; Thomas R Pieber; Jeffrey I Joseph Journal: Diabetes Technol Ther Date: 2017-10-05 Impact factor: 6.118