In re: to medications I am familiar with efficacy (how well a med performs under controlled conditions) vs effectiveness (how well med performs in use by patients in day to day life). I’ve found that the same measures apply to medical equipment submitted for FDA approval. I became curious about this topic bc of problems I encounter with use of Tandem t:slim X2 & G6. I don’t want to compare myself to others who report few problems or no problems. I do find it helpful to read issues which other diabetics have with he use of med tech on websites, pages for support. I & hopefully others learn from and/or feel supported by others. In a strict sense however our accounts of issues with equipment are anecdotal. I am curious about the efficacy & effectiveness rates found during testing for FDA approval.
With today’s incredible med tech for diabetes management I know that many diabetics use the med tech in a very precise manner rivaling controlled conditions & surely have results nearing efficacy rates. On the other hand I think that I am fertile ground for testing effectiveness. Even in retirement no two days are alike. One of my doctors in the past (1970s), an Internist, said thay my profession at the time made managing diabetes a challenge. Additionally I have coped with adhd my entire life. While I have learned a lot for coping daily it is still a struggle to stay organized, fight forgetfulness, stay on time & follow routines.
Any of you who have read my posts know I still struggle with use of med tech. When I use Tandem t:slim x2 and my Dexcom G6 the conditions around my use of med tech equipment are nowhere near being tightly controlled. Hopefully my results fall within the parameters of the FDA approved effectiveness rates for t:slim & G6.
Obviously the med tech for diabetes management which any of us use has received FDA approval & for many of us even Medicare approval. I would like to know if the average person can access the summary of statistics re: efficacy & effectiveness submitted to the FDA by respective manufacturers of the wonderful tech we use. I’m hoping there are members of the T1 Forum working in the medical field who can answer this question.