Anyone see info on FDA approval for new pump that does not require specific carb counting?
Anyone see info on FDA approval for new pump that does not require specific carb counting?
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.
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.
@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.”
“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
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?
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.
The FDA and physicians are rightly concerned about safety, and those with T1D who are NOT managing it well. Unfortunately, that’s the majority and it’s growing in numbers.
Today, for folks like that, a tool that doesn’t require any user judgement besides wearing it to get better results is better than one that takes any skill. Every pump algorithm that the FDA has approved results in lower rates of hypo and reduced average glucose levels.
Personally, I’m dubious of the value of today’s pumps as a return on investment. I’m using one because I know that my perception, memory, attention and physical skills are declining and I’m trying to maintain a good QOL for a few more years.
Prior to my recognizing my decline, I could never justify the cost of a pump or a CGM. For most of my life I couldn’t have afforded either one. I paid for over the counter syringes, vials, meters, strips for most of my adult life. Even at the discounted prices that Medicare pays for CGMs and pumps both are expensive. Now that I can afford them, ironically, Medicare covers them. I try to offset their cost by using them -as long as I can - to get results that reduce my likely years of needing more expensive care.
I believe that I’m succeeding, but as long as I can, I’ll continue to try to do better. I have strong opinions about things that don’t work and those that seem to, and I’m hypersensitive to cost, effort and results.
For us as a society to share the cost, paying for health technology has to be justified by results. I can’t - I won’t - put a price on human suffering, but can only measure it abstractly in years of duration and the cost of care during a lifetime. By those cold metrics, I can only justify the use of insulin pumps and CGMs for those who are incapable - too young, old or too infirm to master simpler tech and their lifestyle. In my admittedly odd way of looking at things, those who could but don’t care for their own health don’t deserve community health support other than education and encouragement to become personally responsible.
It’s not because I lack empathy or resources, but they’re limited. I’ll carry someone too weak to walk but I won’t help a lazy person to stand. I reserve help for those who try, those who would take care of themselves if they knew how to do it. In a forum all I can offer is information. But like horses led to water, I can lead them toward libraries, but I can’t make them think.
@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…
I’m of the same mind.
I’m not impressed by most of the trials that the FDA uses to make their decisions for insulins let alone insulin pumps. The FDA has only two criteria. First, that the product is safe and second that it performs as described. The FDA does not require insulin or an insulin pump to deliver great results just better results than nothing.
The fact is that no clinical trial of insulin pumps has ever shown that it improves A1c to a level that I would consider acceptable, which is below 7.0 for trained educated and conscientious users. I exclude children and older adults who have diminished capacity. Any system that can keep them safer is good enough. The results with children is what finally persuaded me that Tandem had a good enough product.
If that seems like a harsh standard for a product,well maybe it is. I’m an engineer, I’ve had type 1 diabetes for 45 years and I spent the last 20 in IT. I understand single sensor feedback loops. i know what a well-designed algorithm can do to control BG because I’ve been manually using one for decades. I also understand their limits and that a skilled operator is still necessary when the system gets pushed out of limits whether it be from operator inattentiveness, negligence, or sensor failure. I’ve experienced each one of these.
I chose the Tandem pump because I could get it with Basal IQ, disable the software if necessary to get my parameters correct, and once I did - if I thought it was necessary - upgrade to Control IQ.
If it wasn’t possible to disable Control IQ, I wouldn’t have upgraded. I found several things in the behavior of Control IQ 7.4 that weren’t as described during my 6-month study period of it. I found things in the t:onnect site that aren’t quite right and each time I do I report them. I understand the difference between working as described and not and I accept that no system that human beings design will ever be perfect.
I won’t trust black boxes until they prove that they work better than a reliable human could. That’s especially true of the very small computers that are within today’s insulin pumps.
IRC, from a post a few weeks ago, a version of AndroidAPS which does this (requires no carb input) is in testing. (Facebook AndroidAPS group IRC.)
In principle any closed loop system can be used without entering carbs. The system will correct when it detects the BG rise. The problem is that entering the carbs gives the pump a view into the future, so the pump does not have to wait for the BG rise it just boluses.
People with beta cells do it a different way; food initiates a massive insulin dump (the “first stage” response which is lacking in many T2s) then the “second stage” response corrects for the errors. This works because the insulin enters the blood stream immediately (the pancreas is directly connected to the main blood stream). For a pump there is a delay of around an hour for just half of the insulin to enter the blood supply and the ability to correct for overdose on insulin is limited (though, truth be told, the standard human algorithm sucks too.)
My preference given the delays is for a hybrid approach; I bolus the approximate amount when I eat then relay on AndroidAPS to correct. In effect I implement the first-stage insulin response and AndroidAPS does the second stage.