When discussing the criteria for participant elimination, Schwartz states that participants were removed if they exhibited “severe visual impairment” but does not provide any further clarification as to what constitutes visual impairment or how the researchers determined whether a participant was visually impaired. However, we would have liked for the sample to have captured a wider range of diabetes patients, particularly users who are visually impaired.
#Scene analysis for visually impaired how to#
People often learn how to use a product on their own, with the help of the operating manual. We were impressed by the testing methodology used and the inclusion of, and success with, a self-taught group. Through the use of clear objectives for success and failure defined in the study, Schwartz effectively achieved the stated objective of demonstrating the validity of the ClikSTAR in being used correctly among the sample groups. The 99.6% success rate for group A members, with a 95% lower bound of 98.2%, was above the predefined validation limit of 90%. None of the enrolled participants ( n = 345) reported an adverse event during the study. In group B, 93.6% ( n = 44) of participants delivered three successful doses of 40 U, with 134 of 141 individual doses being within the predefined target range. In group A, 99.6% ( n = 255) of participants delivered three successful doses of 40 U, with 767 of 768 individual doses being within the predefined target range. The study measured the proportion of participants who delivered a successful dose, defined as 75–115% of the intended 40 U, on all three dose delivery repetitions. After receiving training or orienting themselves to the device and operating procedures, members of both groups were tasked with delivering three 40 U insulin doses into a receptacle.
These participants were organized into two groups, group A ( n = 256), who were provided training by a diabetes specialist in the proper use of the device, and group B ( n = 47), who were self-trained. Individuals aged 13–79 years who had been diagnosed with type 1 diabetes or type 2 diabetes for at least 1 year were selected based on criteria designed to exclude individuals who were unlikely to be candidates for insulin pens in clinical practice.
The study consisted of two groups of diabetes patients tasked with successfully delivering a set dose of insulin. The author cites the potential for improved long-term outcomes when using insulin delivery devices properly and also warns of the adverse health risks posed by incorrect use, especially in regard to dosing errors. In the article, Schwartz documents the rising popularity of insulin pen devices worldwide as well as the advantages, both health and convenience related, that insulin pens offer over the traditional vial-and-syringe option. In an article in this issue of Journal of Diabetes Science and Technology, Sherwyn Schwartz, M.D., 1 presents a study to validate the design of the ClikSTAR® insulin pen from sanofi-aventis. We believe that future validation studies for insulin administration technology should also include samples of visually impaired users and that visually impaired patients will embrace the use of insulin pens designed with their needs in mind. The study demonstrated successful use of the ClikSTAR insulin pen in a population that did not include subjects with severe visual impairment. Visually impaired individuals need to be included as part of the intended audience for insulin administration technology, and manufacturers of these devices need to design their products for safe use by all people, including those who are visually impaired. Concern with this article lies with the selection of participants, which was meant to reflect the intended audience for the insulin pen device but does not address the inclusion of visually impaired individuals, who comprise over 20% of the adult diabetes population. In an article in this issue of Journal of Diabetes Science and Technology, Sherwyn Schwartz, M.D., presents a study to validate the design of the ClikSTAR® insulin pen from sanofi-aventis and demonstrates that the device can be used correctly by participants with diabetes.
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