# Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes



## Eddy Edson (Oct 2, 2022)

https://www.nejm.org/doi/full/10.1056/NEJMoa2205225
		


_BACKGROUND
Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting.

METHODS

In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed.

RESULTS
A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, −0.5 percentage points; 95% confidence interval [CI], −0.6 to −0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, −0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P=0.39). No episodes of diabetic ketoacidosis occurred in either group.

CONCLUSIONS
In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT04200313. opens in new tab.)_


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## everydayupsanddowns (Oct 2, 2022)

I wondered what tech this was. It’s been a while since I’ve really had my eye on experimentsl developments in the area, but interesting to see Beta Bionics / I-Let continuing to make progress









						Beta Bionics raises $57M to bring its artificial pancreas to the FDA
					

Shortly after wrapping up a pivotal trial of its device in Type 1 diabetes, Beta Bionics has secured $57 million to help complete the development of its fully automated artificial pancreas sys | Beta Bionics has secured $57 million in funding shortly after wrapping up a pivotal clinical trial of...




					www.fiercebiotech.com


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## Eddy Edson (Oct 3, 2022)

everydayupsanddowns said:


> I wondered what tech this was. It’s been a while since I’ve really had my eye on experimentsl developments in the area, but interesting to see Beta Bionics / I-Let continuing to make progress
> 
> 
> 
> ...


It's Beta Bionics tech.


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## Rob Oldfield (Oct 5, 2022)

Does the bionic bit mean that we all have to be jumping over tall buildings, making "beep beep beep" noises when we focus on objects miles away, and generally saving the world on a regular basis?

(Background for any youngsters reading this: https://en.wikipedia.org/wiki/The_Six_Million_Dollar_Man)


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## Eddy Edson (Oct 5, 2022)

Rob Oldfield said:


> Does the bionic bit mean that we all have to be jumping over tall buildings, making "beep beep beep" noises when we focus on objects miles away, and generally saving the world on a regular basis?


No, but I'm not sure the people who've invested in it realise that


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## Docb (Oct 5, 2022)

Did you note that the authors list was nearly as long as the paper!  

Personally I dislike the 'bionic pancreas' tag.  Have they just an improved glucose monitoring / insulin delivery system?  As i have said before, these things can be entitled to be called a pancreas when they are fit and forget forever with no batteries, no tubes, no maintenance and no ongoing routine expenditure.  It could be major step in development of closed loop systems.  Why not be honest and call it that.

PS... yes I know its all about marketing the people to research funding sources but it just gets in the way of the science.


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## Eddy Edson (Oct 5, 2022)

Docb said:


> Did you note that the authors list was nearly as long as the paper!
> 
> Personally I dislike the 'bionic pancreas' tag.  Have they just an improved glucose monitoring / insulin delivery system?  As i have said before, these things can be entitled to be called a pancreas when they are fit and forget forever with no batteries, no tubes, no maintenance and no ongoing routine expenditure.  It could be major step in development of closed loop systems.  Why not be honest and call it that.
> 
> PS... yes I know its all about marketing the people to research funding sources but it just gets in the way of the science.


If it helps them raise the gadzillion dollars it will take to deliver a real product ....  At this point, $$$ more important than the tech which is more important than the science.


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## everydayupsanddowns (Oct 6, 2022)

Docb said:


> Personally I dislike the 'bionic pancreas' tag. Have they just an improved glucose monitoring / insulin delivery system? As i have said before, these things can be entitled to be called a pancreas when they are fit and forget forever with no batteries, no tubes, no maintenance and no ongoing routine expenditure. It could be major step in development of closed loop systems. Why not be honest and call it that.



I have long shared this frustration @Docb

Ever since ‘low glucose suspend’ from the Medtronic Minimed Veo which was able to suspend basal insulin *after* your levels had dropped below 4.0 the press and PR machine has been trumpeting about Person X being the _“world’s first users of the artificial (or bionic) pancreas” _

And then again a year or so later… same headline, but a slightly updated bit of tech.

As far as I’m concerned, rather than raising awareness, the result of all these stories is simply to create an undercurrent that any insulin pump will do everything for the wearer, with no intervention or interaction required.


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