medwireNews: Hybrid closed-loop therapy significantly improves glycemic control and quality of life relative to continuous subcutaneous insulin infusion or multiple daily insulin injections in children and adolescents with type 1 diabetes, research shows.
Timothy Jones (Perth Children’s Hospital, Western Australia) and colleagues say the hybrid closed-loop system “represents an important step in the pursuit of technological advancements toward a fully automated closed-loop system.”
They report in JAMA Pediatrics that the proportion of time in glycemic range (TIR; 70–180 mg/dL, 3.9–10.0 mmol/L) increased from a mean of 53.1% during a baseline 3-week masked continuous glucose monitoring (CGM) collection period to 62.5% at the end of the 6-month study for the 67 participants (mean age 15.2 years, 55% girls) randomly assigned to use the Medtronic MiniMed 670G hybrid closed-loop system.
By comparison, mean TIR increased from 54.6% to 56.1% among the 68 participants (mean age 15.4 years, 57% girls) randomly assigned to receive conventional therapy with continuous subcutaneous insulin infusion or multiple daily insulin injections with or without CGM.
The resulting adjusted mean difference between the two groups of 6.7% was statistically significant and corresponded to an additional 1.6 hours per day in target range for the people using the hybrid closed-loop system, Jones and co-investigators remark.
The authors also note that the improved TIR in the hybrid closed-loop group was apparent during the day and at night, with mean differences of 5.4% and 9.3%, respectively, versus conventional care, and the treatment effect was apparent from 3 months.
Just under a third (31%) of participants using the hybrid closed-loop system met the treatment goal of more than 70% TIR compared with 15% of those using conventional care, while a corresponding 25% and 19% achieved the glycemic target of glycated hemoglobin below 7.0% (53 mmol/mol).
Among the other CGM outcomes assessed, the researchers found that hybrid closed-loop therapy was associated with a significant 1.9 percentage point reduction in time spent in hypoglycemia (<70 mg/dL, 3.9 mmol/mol) versus conventional care and a significant 5.7 percentage point improvement in the coefficient of variation for glycemic variability.
There was no difference between the two groups, however, in the time spent in hyperglycemia, daily insulin requirements, basal insulin, insulin-carbohydrate ratio, or BMI.
Finally, Jones and team compared psychosocial outcomes between the two groups and found that diabetes-specific quality of life improved during hybrid closed-loop system use but declined during conventional therapy, resulting in a significant between-group difference of 4.4 points on the Pediatric Quality of Life Inventory, version 3 questionnaire.
Treatment satisfaction was also significantly better in the hybrid-closed loop group than in the conventional care group, but there was no change in diabetes distress and fear of hypoglycemia scores between the groups.
Jones et al believe their study is the first “to provide conclusive evidence” that using a hybrid closed-loop system “improves glycemic outcomes and quality of life in youth with [type 1 diabetes].”
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JAMA Pediatr 2021; doi:10.1001/jamapediatrics.2021.3965