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Bionic: But It’s Not a Cure. (And a couple other tough questions.)

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The Bionic Pancreas clinical trial device. When the technology clears the FDA and comes to market, all three components will be combined into one device. (Also, I can’t help but to notice that beautiful 123 blood glucose on the graph.)

 

The Bionic Pancreas is a closed-loop medical device intended to regulate blood glucose levels using a subcutaneous infusion of insulin (to lower blood sugar) and glucagon (to raise blood sugar). Both insulin and glucagon are hormones produced by the pancreas, and work in partnership with each other to keep glucose levels balanced.

Using a Dexcom continuous glucose monitor and bluetooth technology, a sensor communicates glucose levels with a sophisticated algorithm embedded in an iPhone. With this information, the system then makes a decision to automatically administer insulin or glucagon (or decides not to administer either one) every 5 minutes — that’s 288 times a day!

{I think I can confidently say that I make basal rate and bolus decisions far less than 288 times a day using our current insulin management regimen.}

If you’re thinking to yourself that it sounds awesome, but it’s not a cure — well, you’re right. The Bionic Pancreas is NOT a cure for Type 1 Diabetes. Rather, it is part of the evolution towards the next phase of technology for managing Type 1 Diabetes.

There are still site changes, CGM calibrations, and pump chamber(s) to fill…and, well, that’s far from a cure. Considering that I don’t foresee cure technology arriving before the goal of seeing the Bionic Pancreas to come to market in 2017, I suppose this will just have to suffice while we continue to wait.

It’s taken 50 years for insulin pump technology to evolve from this:

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to this:

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(Trivia Tidbit: Did you know that clunky backpack up there used both insulin and glucagon for managing blood glucose levels?)

As a parent who allowed her child to participate in a clinical trial for the Bionic Pancreas, there are two questions I seem to get fairly often, so I’d like to take a moment to answer them now:

1) What if the CGM reading isn’t accurate?

If you’ve used a continuous glucose monitor for any length of time, you’re probably intimately familiar with those random wayward sensor readings.

You know the ones: The ones that scream BG is “HI”, soaring over 400………………………but when you do a finger prick, you find the number is really just barely over 200 (or less).

A device that would automatically give insulin to correct a presumed 400+ BG is downright frightening.

I wouldn’t hook that device up to my child.

I would, however, hook a device to my child that had a proven record of being able to keep BGs inside a target range. So, if a little insulin here and squirt of glucagon there manages to keep the BG from skyrocketing in the first place, that’s a good thing from the onset.

In our experience — and I’m speaking only to *OUR* experience — those wayward readings are typically the result of BG movement too fast in either direction. Avoiding those rapid swings altogether keeps sensor data more accurate.

I realize there are other questions in this area — what if a site falls out? what if you lose a sensor? etc. I’ll share my take, and elaborate more, once I have a chance to review my daughter’s firsthand experience.

2) Doesn’t the use of Glucagon just add another dynamic of concern? Is it really necessary to add another cumbersome component?

The other day I encountered a question that went something like this: “Isn’t using glucagon just being reactionary?” The implication being that glucagon wouldn’t be necessary if low blood sugars were avoided in the first place.

I suppose it could be seen that way…but, considering that the use of both insulin and glucagon is how the human pancreas – more specifically the Islets of Langerhans – is designed to maintain glucose levels, I would have to disagree.

Even in healthy, normal pancreatic function, glucagon is a natural component for balancing insulin to avoid low blood sugars.

In a person with Type 1 Diabetes, insulin production is non-existent and glucagon function is severely impaired (hence the reason for those big red boxes in our emergency hypoglycemia stash).

Therefore, if we’re going to call this an “Artificial Pancreas for glucose control”, I believe it’s necessary to incorporate both components.

Otherwise, as far as I can tell, it’s just “Half an Artificial Pancreas for glucose control” — which could very well prove to be great technology…but it still isn’t mimicking the true pancreatic functions necessary for complete glucose control.

As I noted before, there have been vast improvements in technology as it pertains to insulin, and its administration, over the past 50 years.

On the contrary, there has been very little to no movement in glucagon technology over the past 50 years.

That feels very unbalanced to me.

Using glucagon does require another site, another chamber to fill, another component to deal with…but, *FOR US*, this burden does not outweigh the benefit of providing a safety net for severe hypoglycemia, minimizing low blood sugars, and improving glycemic control overall.

So there’s a few answers to some tough questions I’ve encountered on this journey, but HERE’S MY DISCLAIMER: I’m writing this post based on the research I’ve done up to this point, and without the input of my daughter’s data during her clinical trial experience. My opinions are subject to change at any time once I can get my hands on that information…and because this is my daughter’s quality of life that we’re talking about here, people. Ultimately my opinion will always be that whatever works best for her, works best for me.

PS — If you’re interested in a quick recap about how the trial is going so far, be sure to check out Kerri’s post, where the overall impression appears to be: “It works.”

THIS POST IS PART OF A SERIES DOCUMENTING SUGAR’S EXPERIENCE IN THE 2014 BIONIC PANCREAS SUMMER CAMP STUDY.
FURTHER READING:
Category: bionic pancreas
  • Sara says:

    I’d rather wear two pumps than a backpack!

    Keep studying guys!

    August 1, 2014 at 10:25 pm
  • Bernard Farrell says:

    I’m wearing a 2nd pump for the next two weeks and the ‘bionic pancreas’. Basically an iPhone wired with a 2nd Dexcom receiver. Surprisingly my BGs have been much better! This cannot get to the market soon enough.

    May 20, 2015 at 5:40 am

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