Safety Level of Home Insulin Pump Use in Pediatric Patients Hospitalized With Type 1 Diabetes
Although most of the literature on home insulin pump use currently focuses on adults with type 1 diabetes, Sarah Lawson, MD, and her team recently developed a study that looks at the pediatric population. They sought to determine the level of safety in home insulin pump use in children and adolescents who are hospitalized with type 1 diabetes.
Dr Lawson is a pediatric endocrinologist at Cincinnati Children’s Hospital, as well as the inpatient medical director for Endocrine and Diabetes Hospital Insulin Safety Officer
Below is an excerpted transcription of a video interview with Consultant360. Watch the full video here.
Consultant360: What prompted your team’s study titled, “Home Insulin Pump Use in Hospitalized Children With Type 1 Diabetes?”
Sarah Lawson, MD: A lot of this inpatient insulin pump study began with 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 inpatients. We found that insulin technology was very good and advantageous during times of glucose control. And because of that, we knew we needed to step it up and be able to mimic what we teach and do outpatients in the inpatient setting. That’s what 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: 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 are 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 common thing we see on TV and in commercials. But we had to 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: 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 was children who 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.
We liked that comparison because we were comparing it the previous standard of care: insulin injections. And then we also were able to compare an insulin pump managed by a caregiver vs trained medical staff personnel. However, 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. The study did not say which device or subcutaneous shots people got. It was just the medical decision-making and then we pulled from that. Each person needed 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 we had two people go into diabetic ketoacidosis or DKA, and that was all in the subcutaneous shot group. 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 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 in our paper as “time in range” and our very strict range was 80 to 130, and then our more generous range was 70 to 250.
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 the 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.