Real-world data highlight closed-loop frustrations for youth users
medwireNews: System problems and irritations lead to nearly two in five children abandoning use of closed-loop insulin delivery in a real-world setting, researchers have reported.
Furthermore, initial improvements in glycemic control may not be durable for many patients, reported Gregory Goodwin (Boston Children’s Hospital, Massachusetts, USA) at the ENDO 2019 conference in New Orleans, Louisiana, USA.
However, he did stress that the current systems are first-generation, noting that a newer sensor than used in this study reduces the frequency of forced exits from closed-loop mode.
“I do think hybrid closed-loop insulin delivery systems are the future […] but we need better systems,” he said.
Goodwin reported on use of the Medtronic 670G hybrid closed-loop system by 93 children and adolescents with type 1 diabetes, whom he described as “a challenging group from the get-go.”
These patients were aged an average of 17.2 years, with a range of 5.4 to 24.8 years, when they began using the closed-loop system, and 48% were male.
The researchers found a 38% dropout rate over a “variable period of time,” compared with just a 5% dropout rate in the pivotal trial that led to the approval of this closed-loop system for this age group.
The reasons cited for ceasing use of the system included “routine” problems such as skin reactivity and adhesion issues, and sensor supply problems, as well as premature sensor failure, but users also had issues with the frequent alarms and the need to repeatedly calibrate the device, and with forced exits from automode (closed-loop mode).
The latter, Goodwin explained, occurs under circumstances such as when a user remains in hyperglycemia for too long, resulting in the system switching out of closed-loop mode, requiring the user to take manual control.
Study participants who continued to use the system in closed-loop mode reaped the benefits during the first 6 months, with their glycated hemoglobin (HbA1c) significantly reducing over this period. But this benefit was lost after 24 months of use, with HbA1c returning to near baseline levels.
Goodwin noted that these are some of the longest reported follow-up data for users of this closed-loop system.
However, the team did identify a subgroup of users who were “savvy and compliant with this system,” identified as those who used the system in closed-loop mode for more than 57% of time, and who did maintain a significant improvement in HbA1c.
“We need more user-friendly technology for [closed-loop insulin delivery] to be available and practical for the average patient with type 1 diabetes,” said Goodwin.
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