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Day-and-night hybrid artificial pancreas shows promise in well-controlled type 1 diabetes
In patients with well-controlled type 1 diabetes, day-and-night use of a hybrid closed-loop insulin delivery system — including manual administration of prandial bolus insulin — reduced hypoglycemia incidence and was safe and well tolerated, according to results from an open-label, randomized crossover study.
“We showed that, in adults with type 1 diabetes and an HbA1c below 7.5%, day-and-night hybrid closed-loop insulin delivery significantly improved overall glucose control while reducing hypoglycemia progressively by 50% to 75% at lower glucose thresholds compared with usual insulin pump therapy,” Lia Bally, MD, of the Wellcome Trust–Medical Research Council Institute of Metabolic Science, and colleagues wrote. “Beneficial effects on glycemic outcomes included increased time spent with glucose concentration in target range, reduced time with glucose concentration above and below the target range, and decreased meal glucose concentration and glycemic variability.”
Bally and colleagues analyzed data from 29 patients with type 1 diabetes using insulin pump therapy with an HbA1c below 7.5% recruited from two centers: Addenbrooke’s Hospital (Cambridge, United Kingdom; n = 17) and Medical University of Graz (Austria; n = 12). Patients were recruited between March and June 2016 (mean age, 41 years; 15 women; mean HbA1c, 6.9%; mean diabetes duration, 24 years; five used real-time continuous glucose monitoring). Researchers randomly assigned patients to either day-and-night closed-loop insulin delivery (FlorenceD2A closed-loop system, University of Cambridge) or usual pump therapy with masked continuous glucose monitoring, or vice versa. Patients received assigned treatments for 4 weeks before switching to the other treatment, with a 2- to 4-week washout period in between. The study was performed under free-living conditions; researchers did not request changes to diet or daily activities. Primary outcome was the proportion of time spend in the target glucose range of 3.9 mmol/L to 10 mmol/L.
Researchers found that the time spend in target glucose range was 10.5% higher when patients were using the artificial pancreas system vs. usual pump therapy (76.2% vs. 65.6%; P < .0001). Day-and-night artificial pancreas therapy also reduced the mean glucose concentration by 0.4 mmol/L vs. pump therapy (P = .0226), as well as hypoglycemia burden by 73% (P < .0001). Nighttime use of the artificial pancreas also increased time-in-range by 17.2% vs. pump therapy (P < .0001), reduced mean glucose concentration by 0.4 mmol/L (P = .0211) and decreased hypoglycemia burden by 89% (P < .0001). No serious adverse events occurred.
“In adults who are actively engaged with [diabetes] self-management, closed-loop insulin delivery might provide additional benefits, justifying its use in this particular population,” the researchers wrote. “The overall positive feedback from participants reflected the acceptance of closed-loop technology during daily diabetes management, albeit with some limitations to its use, which might affect user adherence and experience.” – by Regina Schaffer
Disclosure: Bally reports no relevant financial disclosures. Please see the full study for the other authors’ relevant financial disclosures.