Most adults, children with type 1 diabetes report benefits with use of bionic pancreas
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Key takeaways:
- Use of the iLet bionic pancreas was linked to reduction in diabetes distress among adults with type 1 diabetes.
- Most children and adults using the bionic pancreas said they would recommend the device.
Most people with type 1 diabetes using an insulin-only bionic pancreas said the device provided more benefits than burdens and stated they would recommend the device, according to findings published in Diabetes Technology & Therapeutics.
As Healio previously reported, the FDA granted clearance to the iLet bionic pancreas (Beta Bionics) for people aged 6 years and older with type 1 diabetes in May. In the BP Pivotal trial, participants using the bionic pancreas had a decrease in mean HbA1c from 7.9% at baseline to 7.3% at 13 weeks, whereas no change in HbA1c was observed for those receiving standard of care. In a new study, researchers examined psychosocial outcomes and acceptability of the bionic pancreas among BP Pivotal participants.
“In addition to perceiving more benefits than burdens, adults experienced a decrease in diabetes-specific distress and a decrease in fear of hypoglycemia,” Jill Weissberg-Benchell, PhD, CDCES, professor of psychiatry and behavioral sciences at Northwestern University Feinberg Scholl of Medicine and collaborative specialty care directory in the Pritzker department of psychiatry and behavioral health at Ann and Robert Lurie Children’s Hospital in Chicago, told Healio. “These are two key clinical constructs that can negatively impact self-care behaviors, so improving distress and fear of lows are clinically meaningful for improving outcomes.”
The BP Pivotal trial included 275 adults aged 18 to 83 years, 71 adolescents aged 13 to 17 years and 94 children aged 6 to 12 years with type 1 diabetes. All participants were randomly assigned to the bionic pancreas with fast-acting insulin aspart or insulin lispro, or standard of care for 13 weeks. All participants were provided with a Dexcom G6 continuous glucose monitor. Standard of care participants continued to use their own personal insulin delivery method. Online questionnaires were administered at baseline, 6 weeks and 13 weeks. All participants except for children aged 6 to 7 years provided responses on diabetes distress, fear of hypoglycemia, confidence in managing hypoglycemia, perceived health status, emotional well-being, attitudes toward diabetes technology, treatment satisfactions and expectations toward automated insulin delivery systems. Caregivers of children and adolescents aged 6 to 17 years also provided responses. A measure of perceived benefits and burdens was also completed for those randomly assigned to the bionic pancreas.
Less diabetes distress, hypoglycemia fear with bionic pancreas
At 13 weeks, adults using the bionic pancreas had a decline in diabetes distress scale score, from 1.9 at baseline to 1.6 at 13 weeks, whereas no change was observed with standard of care (P < .001). At 13 weeks, the bionic pancreas group had a hypoglycemia fear survey score 6 points lower (P = .005) and a WHO Well-Being Index score 5 points higher than standard of care (P = .02).
No differences in psychosocial changes were observed among adolescents or children. Caregivers of children using the bionic pancreas had a more positive change in diabetes treatment satisfaction from baseline to 13 weeks compared with standard of care (P < .001). No other psychosocial differences were observed among caregivers.
“We were a bit surprised to not see similar impact on distress and other psychosocial constructs in children and teens,” Weissberg-Benchell said. “However, when we dug into the data, we learned that those who had enrolled in the study had low levels of psychosocial distress at baseline, leaving little room for improvement after the study.”
Most bionic pancreas users report benefits
All age groups and caregivers in the bionic pancreas group reported more benefits than burdens with use of the device, with 74% to 81% indicating that they would strongly recommend using it. The majority of participants said they trusted the device, worried less about high glucose levels, wanted to continue using the device after the study and felt freer to live their lives. Seventy-one percent of adolescents said they thought less about their diabetes and 85% of children said they felt that they could eat more freely. Most caregivers said they had a greater peace of mind with device use, felt more relaxed, had fewer worries about glucose levels, felt freer to allow their children to do what they wanted to do and perceived their children as having more freedom to live their lives.
Fewer than half of all participants and caregivers reported any burden with the device. Common burdens included annoying alarms, wanting the device to respond faster to high and low glucose and worrying about low glucose during sleeping.
The bionic pancreas group included 92 adults, 18 adolescents and 10 children who used an automated insulin delivery system previously. Of this group, 60% of adults, 67% of adolescents and 90% of children said the bionic pancreas was better than their past system. Additionally, 53% of adults, 61% of adolescents and 80% of children said they preferred the bionic pancreas more than not using automated insulin delivery or using their current system.
Weissberg-Benchell said future studies should examine psychosocial outcomes with the bionic pancreas in specific populations.
“We need to study individuals’ experiences who are technology naïve, individuals who have suboptimal metabolic control and individuals who are typically marginalized and not included in large randomized controlled trials,” Weissberg-Benchell said.
For more information:
Jill Weissberg-Benchell, PhD, CDCES, can be reached at JWBenchell@luriechildrens.org.
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