Pediatric Endocrinologist at UT Health San Antonio/University Health, Jane Lynch, MD talks about a new device that helps type 1 diabetics manage their carbs.
Interview conducted by Ivanhoe Broadcast News in 2023.
So the Genesis of this is your colleague whose son had diabetes. Can you go into that for just a minute?
Lynch: So this is really a special project and I was so excited that we were included to be able to be a part of it. The bionic pancreas was developed for the past 20 some years by Damiano and Steve Russell who have a vested interest in having automated insulin work well. Ed had a son with Type 1 diabetes and if you hear is TED Talk, you’ll hear him describe how he wanted his son to be ready for college with automated insulin was way ahead of the game with all of the ideas that they had. And sure enough, as this came out on his son’s 21st birthday, the FDA let us know this device was approved.
And you guys just published in the journal, correct?
Lynch: Yes, we had.
What is a feeling like, first of all, to invent something that calls that kind of attention?
Lynch: I didn’t invent it but I was lucky enough be one of the few sites where we were able to try these in children. And these devices are a breakthrough in automated using AI for insulin delivery. It’s a whole leap forward from our current pump therapy where we preset and calculate out all the ways we do basal bolus correction insulin to let this device automatically figure out what each child needs, which was really amazing to see as well as our ages 6-79. So it was really exciting to see how this pump worked, not only in children down to age six and adolescence in full blown puberty, but also to look at the literature from our data to see how it worked all the way up to age 79. Just amazing.
What does it do that the other pumps don’t? What sets it apart?
Lynch: It is on the forefront of AI. So the current pumps are basic pumps where you specifically enter every setting for each time of day and adjust it based on your blood sugars. Of course, then that’s not very able to flex for an A day or B day at school or a sick day or a change with a growth spurt for kids. And then the smarter pumps, the hybrid close loop pumps that are out now, you can have the basal insulin compensate for the bolus dosing that we use in the pumps. This device actually works and automates your background insulin, your bolus insulin, your meal insulin. And you literally put the device on your patient, program it with their weight, and their only entry to touch it is to say I’m having a small, medium, or larger than average meal for me for this time of day. And it takes care of everything else to run blood sugars to stay stable.
So which part does the AI do?
Lynch: No, it’s an algorithm. And the current hybrid close loops pumps, which are the smartest pumps, have an algorithm for the background insulin. This one actually has three algorithms. And it- it’s not, every day is not Groundhog Day. Every day is your day where it automates with smaller, more frequent boluses of insulin to quickly keep your blood sugar in range and avoid having it drop to a low blood sugar. And it does this under different circumstances, different schedules, different activities. Because it learns your own biorhythm of what you need at different times of day.
So in this particular patient’s case, she’s 10, is that correct?
Lynch: Yes.
So how is this? Let’s just go right to the chase on this one. How will this impact her life? Because these are kids. It’s hard enough being a kid, much less having a monitor or something.
Lynch: I know. Imagine talk about how non forgiving diabetes is. And then you add that to a family structure where they have to calculate out their carbohydrates for breakfast. They have to make sure the teacher at school and the nurse at school understand how to give a sliding scale to corrected slit. They have to worry about an A day and a B day with a change in schedule. They have sports after school, they have PE classes. All of these can drop of blood sugar, or raise of blood sugar, a birthday cupcake. And it’s so much extra work for families on top of a fairly rigid set of demands for schedule. And it doesn’t take much to fall off the wagon and be even in conflict with your child. So it’s cute to see this.
So on a daily basis when she’s at school, what’s going to be different about this than say a traditional pump?
Lynch: Well she will not be regulated to set a background program to schedule. So if we know that the kids have PE and then she doesn’t have PE that day. If she had a pump that we had regulated and set for basal rates, we might have it back off on insulin for that hour and a half or for the school bus just to be cautious. With this it does on it’s own.
That could be really dangerous for them to have that thing go off. Because it thinks she’s in PE and now she’s not. What things can happen from something like that if it’s a regular pump?
Lynch: Well, regular pumps are the luxury of care as it is. So in this study, we tried to mimic what is out there in the general population. And in a busy academic center on a good day assuming that you’re aggressively treating your kids, a third of the kids are going to be on the smart hybrid closed loop pumps, which we went head to head with. A third are going to be on either old pumps without sensors and a third are on what we think of for diabetes, daily injections where you calculate and use a syringe or a and give insulin before you eat and before you go to bed at night. And with this, imagine how much work it is for these families. For this 10 year old girl, she will put this on, we’ll plug in her weight within four days. It will conservatively give her insulin. Figure out her schedule, keep her blood sugars in the 200s, 150s, and then down to 140, and pretty soon be running independently to give her her insulin. And all she’s telling it is when she announces a meal, is it smaller or larger than she would normally eat for that time of day.
How do you make sure that that software algorithm is on track and doesn’t walk off the track?
Lynch: We’ve been using it now as we’ve launched it commercially. And we started with a few kids who had pretty good control, and we offered it to the kids from the study first. And then we have a child who’s really been struggling with their diabetes and we felt, let’s try it. And we have something called a hemoglobin A1C that tells us the average blood sugar for three months. So this child had a very high hemoglobin A1C above 13, and was really struggling to take care of diabetes and it’s down to 7% and it’s been less than six weeks. And since this was- we launched it I think four weeks ago. It just the family was in awe of seeing what happened in our nurses here in the clinic who went on the study, are really excited right now for us to start working, to get more kits on this device.
Do you see this going beyond where it is right now? Because usually there are stepping stones in medical development.
Lynch: Yes. So one of the next big steps we have for this, which has to my knowledge never been done, is to add a second vial into the pump for glucagon. Not only will the pump back off on the insulin to avoid blood sugars from going low at a very rapid rate, it could even give tiny bits of long acting glucagon to raise it. And so that even makes for a tighter average blood sugar than what we have the current one set for.
From a medical standpoint without giving too much information, can you address her situation pretty succinctly about her specifically?
Lynch: Well, I think this was a family who wanted the best for her and were struggling with diabetes. And as we work with these families one of the issues is coverage for what the insurance allows. And especially Medicaid in Texas- excuse me, for Medicaid in Texas, we’re usually lagging behind in the most recent technology. So we’re pushing this to be approved soon. She’s very anxious to get one commercially as soon as possible, and very reluctantly handed it back in at the end of the study. As we finished up the study, many of the families were calling saying, Tuesday is not a good day, maybe Thursday or a week from Tuesday, maybe we could bring the pump back then.
They want to keep it?
Lynch: If we don’t bring the pump back. Is there some place maybe we could buy some more of vials? So they very reluctantly came back in to hand in their pumps at the end of the studies saying, I don’t have to think about my diabetes more again.
Percentage-wise, how much of an improvement is this pump over traditional and insulin injection?
Lynch: Over insulin injection it’s night and day. And that’s where my career started. I have seen all this technology develop. So with insulin injections it’s very crude and we think of the current insulin injections as so improved over higher quality insulin from years past. But it has no comparison to what this pump can do to fine tune. We just can’t get there with the insulin shot. And then for the pumps, they’re coming a long way really excited. We love the competition between pumps. And as I said, two of the pumps- three of the pumps that are out commercially that we use do have automated basal insulin that tries to compensate. I just walked out of a room of a child who’s on one of those pumps who they couldn’t figure out why his blood sugars were running so high this summer. And when we looked at the download, he had only entered carbs for his meals maybe once a day for the last three weeks was totally busted immediately in the appointment. But you can get the data and you can make adjustments. Sometimes you’re adjusting your carb ratio or your sliding scale. But for him it was just an adjustment of how he was using his pump. It still requires supervision.
Fifty percent better, or can you put it in those terms like what it means?
Lynch: I can just say the ease with this device is a freedom these families have not seen. And that’s invaluable. They’re just really excited about that.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Shelley Kofler Monica Taylor
Shelley.kofler@uhtx.com taylorm1@uthscsa.edu
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