FDA approves Tandem Basal - IQ

Today the FDA approved the Tandem Basal-I update. Looks like we will probably see it this year as promised. Woohoo!

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Any word on how customizable the low targets are?

From this quote, I kind of infer that the target may be 70.

Tandem’s Basal-IQ algorithm is designed to look 30 minutes into the future to predict where glucose levels are heading. The device suspends insulin delivery when low glucose is predicted, then automatically resumes insulin delivery once glucose levels begin to rise. Use of the t:slim X2 Pump with Basal-IQ technology in the pivotal clinical study demonstrated a 31 percent relative reduction in time spent below 70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the feature.

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My guess is that it isn’t programmable. Looking for low suspend at 50 or something?

Well, I know that might sound absurd at first glance.

But if you think about it…what if it suspends at 70 and you already ate something for it? Or if you are low and treat, and it takes a while before the CGM picks up on it, and is suspends after you treated and you are already on the way up?

I think a number like 50 would be more like a safety net. If all else fails, it suspends.

The pump can be more of the mindset of, “you didn’t fix it at 70 or 60, you had your chance, now I will step in and do it…”

The other thing that bugs me about it is that it “predicts” when you will be below 70. Not even below 70, but just predicted.

It predicts 30 minutes into the future?!? That seems like all kinds of possible room for screw ups.

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I don’t disagree with you, we will be testing it out when it arrives. Hopefully you can time bound the thing. The only time we really care about disrupting insulin delivery is at night when going low.

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This is the inherent problem with all pumps that make decisions for you. The only algorithm I trust implicitly resides in my head.

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The whole idea of predicted to be below 70 within 30 minutes kind of struck me as funny, because that’s kind of what I am always trying to make my CGM look like.

I also think that 70 number has been so heavily mandated by FDA or the medical community to be declared a low number.

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I just read about this and it honestly makes me SO EXCITED! Lows are one of my biggest problems, especially overnight and during activity (which is often not planned “exercise” sessions for me, but just part of everyday life and my job). I was considering not getting this pump because I’m concerned about it not being truly waterproof. But I dunno, after reading about this feature, it makes me really excited. I want a pump that predicts and prevents me from going low, not just one that treats a low as a last-ditch effort. The thirty-minute prediction and treatment is exactly what I often try to do, because if I only catch it fifteen minutes before I go low, it’s usually too late by that point given the CGM lag time. I’ll take a few screw-ups that are easily fixed with a unit of bolus insulin for the overall burden that would life off my life.

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My son uses the pump, and really loves it. As does @Thomas, and some others here. If you have any questions, just ask.

The fact that Tandem offers upgrades to their current technology as so far, hasn’t asked for additional money to turn things on has been a plus.

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Kind of a bummer though to have to go through all the Insurance reviews to now be approved for Dexcom G6 & PLGS to do the update. It’s going to be a hassle for some, myself included. As much as I am interested in the PLGS, I may be forced to stick to the G5 because of my insurance

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Does the Basal-IQ work with the G5 or only the G6? I’m willing to upgrade to the G5 if I have to, but I won’t be upgrading to the G6 for as long as possible due to how expensive it is for those paying out of pocket. If the low suspend only works with the G6, that unfortunately means I’ll probably give it a pass because I can’t take advantage of the feature if I can’t afford to use the CGM (that’s actually a main reason I haven’t just gotten the 630G already, the increased cost of the CGM not being able to stretch sensors).

Of course, this is all assuming both the t:slim and G6 get approved soon. I can’t decide on the t:slim until I see it in my hands, because I also have concerns about seeing and operating the pump with low vision. I’ll also be evaluating the Omnipod and 630G as my alternative choices.

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The PLGS is with the G5, G6,the closed loop will be with the G6. See the link below for more info. They gave us the G5 integration last year, so it wouldn’t make sense for the PLGS to be available with the G6 until they do more work on that.

[Link was wrong and old information]

:tired_face::sob::frowning::exploding_head:

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Hi Elver, can you explain the issue?

Do you mean you want to stay with G5 because sensors are cheaper because you can restart them? Or do you mean it is a hassle to go from G5 to G6 because of insurance?

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So the email I received from tandem stated that I would have to get an Rx for the PLGS and the G6. The initial press release stated that PLGS worked with G5, but it seems like based on the email that Tandem is only going to allow the update with a G6 system. Definitely a bummer as I just re-upped on transmitters and asked for G5s instead of G6 (since the G6 doesn’t work the Tandem pump yet). When it’s time to reorder transmitters again, I will be on new insurance, and the fun will truly begin.

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So currently you need to be on the G5 to work with your Tandem, but the next Tandem release with PLGS will be with the G6 and then you will need to get approval for the G6 - did I get that right?

But going from G5 to G6 with insurance should not be too difficult, right? If you are approved for G5, wouldn’t an upgrade to a newer version be easy?

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In theory it should be, but insurance companies in my limited experience do everything they can to disqualify you. Insurance approval is like Voodoo magic - something you intellectually know is right or wrong, but can’t necessarily explain.

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Yes, what you are saying is true.

But things like upgrades are generally easier than getting something totally new. Hopefully that will be the case for you!

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@Eric I do hope. At this point it’s about managing expectations for me. I am eternally grateful to have and be able to afford a pump. I have serious hypos. PLGS would benefit me, but who knows with the insurance. It’s not worth it to me if I will lose what I already have because of a review.

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I don’t think they can remove what you have if you apply for the G6 and don’t get it.

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Well I just got off the phone with Tandem, and clarified a few things. Unfortunately, neither answer is what I was hoping to hear. As @elver stated, the PLGS algorithm is only available if you upgrade to the G6, which sucks for us. We just received enough sensors to last 1/2 a year, and won’t be burning those any faster than necessary.

Second, the low trigger of 70 is non-programmable.

Not a great answer in either case for us.

If their closed loop system is likewise a black box without meaningful user inputs, that won’t be much help, except during college when his control is likely to be worse due to the environmental issues.

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