New Pump FDA approved

Anyone see info on FDA approval for new pump that does not require specific carb counting?
medpagetoday

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Haven’t heard anything about it, but I’m not well connected. That’s not an A1c that most people in this group will find admirable, but we’re probably not the target audience. I think we’re all hyper-vigilant, and this seems to be aimed at others who are more relaxed.

mh

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I am assuming that you can use the technology to achieve the desired A1C just as people manage very low A1C with the currently available pumps. The hope would be that this new tech would make that easier.

Considering the unreliability of Dexcom for some of us , me included, this would be a recipe for disaster.

I use Tandem with C-IQ and G6, but I do finger sticks now and then. If the G6 is reading lower than actual blood glucose C-IQ will drop the basal to near zero causing BG to rise. When I get a low alarm and do not feel hypo, I use my Contour Next One to see what is actually happening. Often it is rising BG because of the decreased basal requiring and overridden correction.

I don’t often do a calibration because the difference often rights itself after a time.

For those lucky people who have really consistent CGM readings compared to finger sticks this pump might be an option.

With not so perfect CGM data and combined with duel hormones It could put someone into the hospital.

I’m actually really surprised by this. To my knowledge, they were still testing the system wearing 2 CGM sensors at once and were only testing insulin. I was completely unaware they had moved to this stage, let alone got approval for the dual hormone system.

I know one amongst us here participated in a clinical trial for this pump and wound up going back to the T:slim as they weren’t doing well on the system.

ILet had one approved late last week, but does it require carb counting? I have no idea,

The data is alarmingly bad. I can’t imagine buying a pump that advertises a7.3 a1c like that is a successful outcome.
I understand the need for a totally hands off system, but this one only allows meals that are large medium or small.
It doesn’t save any work or steps but has a worse outcome from the other 3 options on the market.

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@Timothy: This pump is not for you.

Beta Bionics wants to:
“…reduced mean HbA1c across populations regardless of race, education, or income level.”

Beta Bionics Director of Medical Affairs Jeanne Jacoby said:
“As a nurse practitioner and diabetes care and education specialist, I have always said a diagnosis of diabetes does not come with a math degree.”

And:
“I was excited to see that the exploratory sub-group analysis shows consistently reduced mean HbA1c regardless of education level for those in the bionic pancreas group.”

The users of the bionic pancreas also experienced a reduction in diabetes distress and fear of hypoglycemia with statistically significant differences.

You can read more here:
Data supports Beta Bionics’ iLet bionic pancreas

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It’s not close to the 6.0% that is my goal but it’s a LOT better than 8.5% where, sadly, a lot of people find themselves. Perhaps for some folksit’s a step in the right direction?

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Ah, I did a survey on that thing I think. Wasn’t too impressed.

For me, the issue is 1) my G6 is far more accurate than the meter covered by my health plan (that meter reads much higher than actual - causing - or directing me - correct when that’s the last thing I need). 2) my schedule - especially eating if I am higher than I want to be I correct but don’t eat. If I am at target (80 bg) and flatlining and not hungry I don’t do anything. 3) I guess I am a control freak. I like having my foot on the accelerator, brake and clutch on my T1D journey. I wouldn’t be comfortable giving that control up. I did see comments by the study participants that that was an issue for them. 4) carb counting is helpful to me in my trying to lose the 15 lbs for which I am scolded by the Endo’s. If there are too many (meaning a fairly large bolus) I don’t eat. I currently use the Tandem X2 wtih BIQ. CIQ target is too high for me.

@Lcakes1 From your description, sounds like the recently announced iLet Beta Bionics pump. It only reportedly takes two entries by the user: weight and size meal (normal, larger, smaller) and the algorithm works out a dose from those and “learns” with time (how much time has not been stated). It had good reviews from its clinical trial, but then most do, because the companies run the trials and the reporting from them. They’re also reportedly working on a second pump that uses both insulin and glucagon, a dual cartridge arrangement to treat both highs and lows, somewhat similar to actual pancreas.

I tend to dislike “black boxes” approaches in which I don’t know how they work, unless they have a significant history of working well. I prefer to know how something works so I know what my actions/differences may cause to happen. Only time will tell…

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