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Closed-loop insulin at home proves safe, feasible in type 1 diabetes
In adolescent patients with type 1 diabetes, the home use of unsupervised day-and-night hybrid closed-loop insulin delivery appears to be safe and feasible.
Further, the closed-loop insulin delivery may improve glucose control without increasing the risk for hypoglycemia in those with poorly controlled diabetes compared with sensor-augmented insulin pump therapy, according to the researchers.
Roman Hovorka, PhD, of the Wellcome Trust-Medical Research Council Institute of Metabolic Science at the University of Cambridge, evaluated closed-loop insulin delivery and sensor-augmented insulin pump therapy in 12 adolescents aged 10 to 18 years with type 1 diabetes to determine the feasibility, safety and efficacy of each system.
Roman Hovorka
Participants underwent two 7-day periods, randomly ordered, during which glucose was controlled using sensor-augmented insulin pump therapy or hybrid closed-loop insulin delivery without remote monitoring; participants using the closed-loop system used a standard bolus calculator to administer insulin at meals. A 1- to 4-week washout period occurred between the two treatment periods. During this time, participants utilized the study insulin pump with their standard pump settings and continuous glucose monitoring was discontinued. The study’s primary outcome was the percentage of time in which glucose was in the target range (3-10 mmol/L) during the 7-day study intervals.
The proportion of time that the sensor glucose concentration was in the target range was significantly increased during closed-loop delivery (72%) compared with pump therapy (53%; P < .001). Closed-loop delivery yielded a significant decrease in mean glucose levels (P = .028) and the proportion of time spent in excess of the target glucose level (P = .005) without causing an increase in time spent in hypoglycemia. Closed-loop delivery also increased time in the target glucose range and decreased mean glucose levels without increasing total daily insulin dose (P = .55).
Closed-loop delivery yielded higher total basal insulin delivery (P = .001) but was counteracted by an inclination toward lower bolus delivery (P = .06) likely attributable to lower glucose levels resulting in decreased correction boluses.
“We have demonstrated that day-and-night hybrid closed-loop insulin delivery can be used safely in adolescents at home without supervision,” the researchers wrote. “Its benefits include an increased time when glucose is in the target range and a reduced mean glucose level. Larger and longer studies are warranted.” – by Jennifer Byrne
Disclosure: Hovorka reports various financial ties with BBraun, Eli Lilly, Medtronic, MiniMed, Profil and Sanofi. Please see the full study for a list of all other authors’ relevant financial disclosures.