Hybrid Closed-Loop Therapy Boosts Glycemic Control in Youth With Type 1 Diabetes

By Scott Baltic

December 01, 2021

NEW YORK (Reuters Health) - In children and adolescents with type 1 diabetes, a hybrid closed-loop (HCL) system significantly improved glycemic control and quality of life compared with conventional management, researchers in Australia have found.

In addition, time in the target glucose range of 70 mg/dL to 180 mg/dL was increased during both day and night times, the team reports in JAMA Pediatrics. The HCL system also improved most continuous glucose-monitoring metrics, with respect to clinical targets recommended by an international consensus statement.

"The HCL system represents an important step in the pursuit of technological advancements toward a fully automated closed-loop system," Dr. Timothy W. Jones of Perth Children's Hospital and colleagues write.

To their knowledge, the study is the first randomized controlled trial "to provide conclusive evidence that HCL improves glycemic outcomes and quality of life in youth with" type 1 diabetes, they note.

The multi-center, open-label phase-3 trial included 135 adolescents and young adults (mean age, 15) recruited between 2017 and 2019. The HCL group received the Medtronic MiniMed 670G insulin pump (which is no longer made), glucose sensor (Guardian sensor 3) and transmitter (Guardian Link 3), along with training on the system.

Control-group participants continued standard therapy, consisting of continuous subcutaneous insulin injection or multiple daily insulin injections, with or without continuous glucose monitoring.

At the end of 26 weeks, the mean percentage of time in target glucose range increased from 53.1% at baseline to 62.5% in the HCL group and from 54.6% to 56.1% in the control group, with a mean adjusted difference between the groups of 6.7% (P=0.002). The mean difference amounted to an additional 1.6 hours per day in the target range for patients on HCL.

Greater time in the target range was seen across both day and night and was associated with a reduction in hypoglycemia and glycemic variability, though not with a reduction in hyperglycemia.

HCL users had higher scores on a diabetes-specific pediatric quality-of-life measure than did patients receiving standard therapy.

"The trial used the first iteration of the HCL system," Dr. Jones told Reuters Health by email. Future systems, he added, will have fewer alarms, require less intervention from users, and be capable of adjustment to different target levels. He compared this evolution to the ongoing development of mobile phones.

Dr. Roy W. Beck, medical director of the Jaeb Center for Health Research Foundation Inc., in Tampa, Florida, who was not involved in the study, said the extra time in target glucose range with HCL was "clinically meaningful."

He noted in an email to Reuters Health that the Medtronic 670G is being replaced by the 780G system, "which has an upgraded software algorithm and can be expected to have a better user experience."

A trial that he and colleagues reported earlier this year, comparing the 670G and 780G systems, showed greater efficacy with the 780G on time in the target range, Dr. Beck said. "Thus, the very positive results from this trial could only be expected to be better with the new system."

The study was funded by the Juvenile Diabetes Research Fund Australia. Medtronic provided the HCL system components. Three of the 14 authors disclosed financial ties to the company.

SOURCE: https://bit.ly/3p8W8ju JAMA Pediatrics, online October 11, 2021.

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