Two researchers discussed the advantages and disadvantages of automated insulin delivery (AID) devices compared with pancreatic cell transplants, which are currently considered experimental in the U.S., during Comparing Beta-Cell Replacement vs. Artificial Pancreas—Smart Insulins with a Focus on New Innovations—Untested Technologies. The session can be viewed by registered meeting participants at ADA2023.org. If you haven’t registered for the 83rd Scientific Sessions, register today to access the valuable meeting content through August 28.
“Looking at real-world data for AID devices, there are 132,677 analyzed users now. They’ve been tested and used in all age groups,” said Bruce A. Buckingham, MD, Professor Emeritus (Active) at Stanford University.
Dr. Buckingham discussed data on several technologies, including the CamAPS FX hybrid closed loop app, the Control-IQ Advanced Hybrid Closed-Loop Technology, the Medtronic MiniMed 780G, and the Omnipod 5, noting that some devices dose insulin every five minutes.
In a 2021 study of 7,813 people with type 1 diabetes treated with Control IQ, 94% used the system for a year with no drop-off, and patients spent 75% of the time with their A1C in the target range, Dr. Buckingham said.
In another study in 2022, 18,354 people living with type 1 diabetes saw their time in range dramatically improve within a day of starting to use Control IQ. Users 25 years and older achieved a time in range similar to participants in the 2021 study. Adolescents in the 2022 study also saw improvements in glycemic control while using Control IQ, with time in range approaching 70%, Dr. Buckingham said.
He compared the experience with AID with the emerging technique of pancreatic cell transplantation. Patients using AID achieve glycemic control with minimal long-term complications and a low risk of severe hypoglycemic events, he explained.
In one 2016 study, there were 30 serious events in the first year among the transplant recipients, including cytopenia, abdominal pain, cytokine release, infections, renal dysfunction, lymphoproliferative disease, a small intestine carcinoma, and two seizures, he said.
“There was a 33% failure rate, so they did that and then they were back to severe hypoglycemia,” Dr. Buckingham noted.
Unlike patients using AID, which involves devices that require only insulin for use, patients who receive islet transplantation also have to take immunosuppressive drugs, resulting in a rate of infectious disease as high as 76%.
“You’re getting anti-thymocyte globulin, sirolimus, and tacrolimus, which causes increased creatinine and hypertension. These drugs are not for the faint-hearted,” Dr. Buckingham said.
Michael R. Rickels, MD, MS, the Willard and Rhoda Ware Professor in Diabetes and Metabolic Diseases at the University of Pennsylvania Perelman School of Medicine, made the case for beta-cell replacement, pointing to a 2022 oral presentation from the European Association for the Study of Diabetes stating that while the advent of hybrid closed-loop interventions has significantly improved the number of patients treated with AID achieving the desired time in range, 40% of patients still struggle to meet that goal.
“We still need to look at biological solutions,” he said.
Dr. Rickels compared the results from two studies, one of patients treated with AID to be published this year and one of patients treated with islet transplantation.
“Epinephrine secretion improved with both treatments, but it became normal after 18 months of complete avoidance of hypoglycemia afforded by islet transplantation, where it was still impaired in those treated with the device,” Dr. Rickels said.
In addition, while autonomic symptoms improved for patients in both studies, islet transplantation abolished impaired awareness of hypoglycemia, whereas a portion remained among those using AID, he said.
“Islet transplantation restores the glucagon response and physiologic counterregulatory defense against hypoglycemia,” Dr. Rickels explained. “We don’t have a glucagon response—yet—with AID, but there are bihormonal systems in development, so we may see that, but right now we still have impaired counterregulatory defense in individuals on AID.”