Saturday, August 10, 2019

Clinical Trial begins!


TWO SENSORS!
The clinical trial begins!

Cat was selected to participate in the pediatric trial for the Tandem t:slim Control IQ.  If you aren't aware, Control IQ will be Tandem's answer to a hybrid closed-loop insulin pump system. The Control IQ will not only stop the basal insulin with a predicted low blood sugar, as it does now with Basal IQ, but it's my understanding that Control IQ will auto-correct for high blood sugars, based on CGM data, which the 670g does not do. You can read more about Control IQ here

Since January 2018, Cat has been using the Medtronic 670g insulin pump with the Guardian 3 continuous glucose monitor sensors. We have been extremely happy with this system and have had great results with Auto Mode. The Medtronic sensors have been VERY accurate for us as well. I imagine that Control IQ would be similar, but not exactly the same as the hybrid closed-loop Medtronic 670g.

But....new tech is exciting to me, so when I was scrolling through clinical trials (which I do on occasion) and I found a study that was close enough so that Cat could participate, I was ECSTATIC. At first, we were waitlisted for the trial, but then the call came that she was IN! Cat doesn't mind new things either...when I explained what we would be doing, she was all like, "whatever". 

At our first visit, we had our screening appointment. A fingerstick A1C was taken, medical records were reviewed, current pump info was downloaded, and the study was explained in detail to us by the doctor. We signed all of the paperwork. Now, because we've only used the Guardian 3 sensors and not Dexcom for this last 1.5 years, we have to do what is called the "run-in" phase of the trial. All this means is that she has to wear a Dexcom for at least 11 out of the next 14 days. We got set up with the Dexcom G6 including downloading Share and Follow. During the run-in phase, we can still use our Guardian sensors and still use Auto Mode. SO, I thought this would be a great time to do a comparison of the two Continuous Glucose Monitoring Systems! 

I'll post my opinion + data regarding the comparison at the end of the two weeks, after we go back to to meet with the trial coordinator, as well as which part of the study we are randomized to: either the control or the experimental group. The control group wears their regular pump with a dexcom. The experimental group gets to wear the t:slim with the dex and Control IQ! Both groups eventually get to wear the t:slim with Control IQ in the last phase of the trial. 

Fingers crossed we get in the experimental group. I just think it will be really interesting to try the new technology before it's FDA approved! Plus, we are helping pave the way for children to be approved for this new technology when it comes out. 

So far, with today being day 2 of the Dexcom and day 1 of our new Guardian sensor, the numbers have been pretty accurate, and comparable to the fingersticks we've done as well. (Right at this moment Guardian is showing 129 straight arrow, and Dex is showing 127 straight arrow). 

Here is a pic from earlier: 

Cheers to new and improved diabetes technology! 





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