Home Insulin Pump Use Safe for In-Hospital Care Among Pediatric Patients With Type 1 Diabetes
Although most of the literature on home insulin pump use and safety involves adult users, Sarah Lawson, MD, and her team set out to determine the level of safety involving home insulin pumps in children and adolescents with type 1 diabetes during hospital admissions compared with hospital-managed insulin pumps or insulin injections. In this video, Dr Lawson discusses her team's study results, whether she was surprised by the results, and how this study impacts future studies covering diabetes technology.
Additional Resource: Owens J, Courter J, Schuler CL, Lawrence M, Hornung L, Lawson S. Home insulin pump use in hospitalized children with type 1 diabetes. JAMA Netw Open. 2024;7(2):e2354595. doi:10.1001/jamanetworkopen.2023.54595
TRANSCRIPTION:
Sarah Lawson, MD: Hi, my name is Sarah Lawson. I'm one of the endocrinologists at Cincinnati Children's Hospital Medical Center, and I'm in charge of the inpatient medical director position and then I’m also the Housewide Insulin Safety Officer.
Consultant360: What prompted this study?
Dr Lawson: Really, a lot of this inpatient insulin pump study began by patient-parent feedback. Five, six, seven years ago, we were only doing injections for every patient with diabetes who came into the hospital. Technology was outpacing us as far as what we could offer inpatient.
We found that insulin technology was actually very good and advantageous during times of glucose control. And because of that, we knew we needed to kind of step it up and be able to mimic what we teach and do outpatient on the inpatient setting. So that's what kind of prompted us to say we need to get better at doing the insulin pumps, continuous glucose monitors. We need to be able to mimic that inpatient when the kids are admitted.
C360: How does this study fill a current gap in our knowledge?
Dr Lawson: Yeah, so most of the literature right now is adult-based. And so, the information, the statistics, and the outcome measures have all been during times of adult hospitalization. It's not easy to extrapolate that into pediatrics just because there's different illnesses coming in. There's different medications that are running at the same time. And in the adult world, the patient mainly is taking care of their insulin pump. Where in the pediatric world, you have a caregiver. So it's another level of potential complexity that says it's not just the patient who understands what they're doing, but now you have different caregivers coming in and out of the room who are also responsible for this.
And the insulin pump is a pretty common thing we see on TV and commercials. But we had to kind of step back and remember it is a high-risk drug that's being delivered. And so how much could we say the pump is trustable and even just any caregiver walking in and out of the room without meeting every one of them? How much could we say that a high-risk drug could be delivered without us on top of it managing it step by step?
C360: Can you please provide an overview of your study results?
Dr Lawson: Yeah, sure. We did three comparisons. So, the first group was patients who had received insulin based on their need and it was just by insulin injections, subcutaneous injections.
The second group were kids that remained on their home insulin pump during the hospitalization. And then the third group was we have insulin pumps that are owned by the hospital that bedside nurses and endocrinologists manage while they're on the patient. And so that was our third group.
We liked that comparison because we were comparing it to kind of the previous standard of care: insulin injections. And then we also were able to compare an insulin pump managed by a caregiver versus trained medical staff personnel. Though we did not require anyone to be in any certain group. So the medical care that you required depended on which group you're in. So the study did not say which device or subcanteous shots people got. It was just the medical decision-making and then we pulled from that. So each person was needing the required type of insulin delivery based on their medical condition, not based on the study.
What we found was the hyperglycemia rates or blood sugars over 250 were much, much lower on an occurrence rate in the groups that were on either a hospital pump or a home pump. The hypoglycemia rates, we said under 65, and then we also did under 45 to get the severe hypoglycemia. We didn't notice that much difference between the three groups. But the biggest thing is that the only people, we had two people go into diabetic ketoacidosis or DKA, and that was all in the subcutaneous shot. No pump person went in DKA during their hospital stay. No patient required an insulin drip after they were admitted. So if they did not come in in DKA, they did not go into DKA during the admission on the pump, which is a big thing we wanted to see.
And then probably one of the biggest things is just how quickly did their blood sugars get under control, and how long did they stay under control? So we termed that into paper time and range and our very strict range was 80 to 130, and then our more generous range was 70 to 250.
And when you look at the paper, the patients on an insulin pump got under control much faster and they stayed under control the majority of their hospital stay. The patients who were on insulin, subcutaneous shots did not get under control as fast, and they had a lot more variability in their blood sugars.
C360: Did those results surprise you?
Dr Lawson: We had a lot of trust in the pump before the paper, so our thoughts were confirmed as far as would the pump be accurate. The part we did not know was the variability in caregiver and who was at bedside at what time of day. And then also the hospitalization as far as the regulatory standards that we had to meet, we were a little nervous about, could the regulatory standards be maintained, and also the safety of insulin delivery? And it was. And that's what we were very pleased to see is that we could keep the regulatory standards completely under control, and maintain good glycemic control during this day.
C360: What do you plan to study next considering the rapid advancement of diabetes technology?
Dr Lawson: That this was a steppingstone because our ultimate goal is to be able to introduce automated delivery systems or closed loop systems into the hospital setting. There's a lot more regulatory guidelines against them right now, but because of this step, we were able to do with the home insulin pump to demonstrate that it's safe.
There are a lot of ways that you can monitor it and make sure that the pump is doing what it should, and the patient has the control that he or she needs. And because of those standards and because we were able to show how safe it was, we're now working on doing the automated insulin delivery systems in the hospital.
So we haven't started them yet. We're still ironing out a few kinks that we've had, but if this study had not been done, we probably wouldn't feel as brave to do the automated delivery systems in the hospital. So we're probably 60% to 70% done with trying to figure out how to get that into the hospital. And under a good control for the patient. We're able to monitor with them to make sure everything's going well. And then if a regulatory survey comes in, it wouldn't be the end of the world on that one too.
So trying to figure out all three levels of that. But I think this study was a good steppingstone. to let us be able to move towards that as the goal.
C360: What was the main takeaway from your study?
Dr Lawson: Yeah, so one thing that we tried to do, and this is never 100 % in any study, but we tried to make it very universal so that you don't have to have our exact hospital to get this done. So we did it on every level of illness minus the critical care units. So any non-critical care unit, the hospital, we allowed the home insulin pump to go on.
We also did not put any restrictions on which service was managing them because endocrine was involved in every one of the services as a consult at minimum. But we did not put any restrictions on the service outside of psychiatry, which is listed in the paper. And then we had patient by patient determinations of who was eligible for the pump.
So, it was not a blanket inclusion exclusion criterion; it was patient by patient. And then we tried to make it so that any level of care, any level of knowledge of a unit, was able to maintain this and have the pump work as it should.
So even though every hospital is different, we tried to normalize the study as much as we could so that hopefully it can be transferred to as many hospitals as those who want to. Yes, there'll have to be small adaptations per hospital with it, depending on how they function. But that was one of the big goals we had was that you didn't have to be here to have it work. It really could flood over into anyone who was interested in using this.