Efficacy vs Effectiveness Med Tech

Technology & Management
#1

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.

#2

hi Henry! @Hen51

so I followed the investor web page to the “Clinical Evidence” page at Tandem
here is the page
https://www.tandemdiabetes.com/providers/clinical-evidence

it will take you to the documents which will have the related data and conclusions (excerpt below)
Results: In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55±13% using SAP during the RCT to 65±10% using CLC (P<0.001), with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1% compared with 14% when using SAP (P=0.03). Substantial improvement in TIR was seen after the first day of CLC. Time <70 mg/dL decreased from 1.80% to 1.34% (P<0.001). In the CLC-CLC cohort, mean TIR increased from 53±17% pre-randomization to 67±10% during the RCT and remained reasonably stable at 66±10% through the 12-weeks post-RCT. There were no episodes of diabetic ketoacidosis or severe hypoglycemia in either cohort.

the above from Diabetes Journals link here https://diabetesjournals.figshare.com/articles/figure/Extended_Use_of_the_Control-IQ_Closed-Loop_Control_System_in_Children_With_Type_1_Diabetes/13260212

for each statement made. now it is likely that adverse and contradictions will have to be calculated, if not directly reported.

Good luck!

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#3

@Hen51 , one last thought… funny you mentioned ADHD, I turned my ADHD into a creative technology endeavor, I’ll explain: because my methods are not linear, and to some may be observed as either random or downright circular, I’ve managed to profit by my ability to innovate, design, and troubleshoot technical problems. Plus ADHD wasn’t a diagnosis for me I was just labeled fidgety and troublesome with an inability to develop or adhere to structure… I just can’t do routine things efficiently!

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#4

Thanks for links to the info I was seeking!

#5

It’s been close to 50 yrs since statistical analysis in college & nearly 30 since same course in grad school so I’ll need to look up a few terms. I’m sure however I’ll get there. Thanks

#6

Like you Henry @Hen51 the way I live my life fully, and my employment activities [working with a “gang” of field auditors moving from hotel to hotel, etc.] never allowed for “controlled environment” for managing my diabetes. Even during my 10+ year retirement [except for pandemic restrictions], no two days in a row are the same; we enjoy going to restaurants where I will eat whatever catches my eye. Add to that, during a week stay in the Teaching Unit at Joslin Clinic [a live-in with controlled food, insulin, etc.], I was diagnosed as “Clinically Brittle”.

Before adopting the Tandem (UVA) Control IQ algorithm [CIQ] using the t-Slim x2 with Dexcom G6 in January 2020 I was very skeptical about the effectiveness for me. The endocrinologist who ended up writing the prescription also had her doubts - but she trusted my decision.

I’m not bragging or gloating, but rather expressing my joyful surprise, to find that to report that with the CIQ, my time-in-range [TIR] on the international standard of 70 - 180 mg/dl increased by about 15% using the AGP Report form.

What I consider to be “key” to success with CIQ is that I try to be HANDS-OFF and let the algorithm do its thing without me micro-managing the system. The most positive outcome is that I have not had any hypoglycemic events when CIQ do its thing - no more calls to EMS.

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#7

Great progress. I may try C-IQ again.

#8

I should add Henry @Hen51 that I truly believe that I had a great load of Irish luck.

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