Replies to This Discussion

Permalink Reply by S Woodward on December 26, 2011 at 9:27pm

Given that the APwill not use the current CGM technology, will not use current insulin, will use a tried and proven algorithm, and will be dependent on the user to setup and train the algorithm, I have no hesitancy usung the AP as it is being used in clinical testing and as a released product. The real challenge will be the FDA in approving the tech that will support the AP.

Currently there are several T1D medical devices being used w/o issue for >2yrs that are saving lives by shutting of with lows and providing FAR greater CGM (next generation) accuracy to greatly improve control & life quality. My beef is with the arrogance of the FDA to treat T1D medical product like pharma products. The reality is that if a T1D product is designed w/ minimal user interface complexity (not like those that have caused many of the pump gone amuck incidents reported to the FDA) the device will provide minimum risk and if it does not work it will be immediately apparent (and not get approval).

Focus complaints at the FDA for not providing a guide to manufacture so that we can have current CGM sensors and pum software!!!!

Even the guidance doc for the AP are incomplete event thought the hearings started in Nov. 2010...over a year?

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Permalink Reply by Anthony Holko on December 26, 2011 at 10:35pm

The AP suffers from 3 major stumbling blocks: 1) inaccuracy of CGM 2) time delay of CGM 3) time delay of the injected insulins. Time delay is a demolisher of the performance of closed loop systems.

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Permalink Reply by S Woodward on December 28, 2011 at 7:56pm

These are not major issues w/current clinical work.

Several of the AP systems in clinical test at the moment and in the near future are using the next gen of CGMs which DO NOT work like the current versions of sensors and respond in .5 or less the time with blood to interstitial readings, and are o will be using ultra fast insulin (5 min start, 60 min. done) which is what several of the AP algorithms are based on.

The stumbling block is the FDA not the AP or the AP technology.
Currently, outside of the US, multiple clinical studies have patients wearing closed loop system at home w/o medical personnel right next to them or in the other room...successfully.

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Permalink Reply by acidrock23 on December 29, 2011 at 8:41am

There's an interesting blog @ sixuntilme from Abby, who did a trial recently. Apparently if you puke you are "out" of the trial which makes me think there may be other stumbling blocks besides FDA approval. She also mentions that there's a ton of equipment involved which makes me think that co$t may also become a barrier? If I can get ok control for what I'm spending now (also a ton of money, even with insurance...) why would I spend more to have the new gizmo, particilularly since BCBS will likely adopt a similar stance?

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