Полностью автоматизированная система доставки инсулина и прамлинтида показала эффективность при диабете 1 типа

Fully closed-loop system with insulin lispro plus pramlintide may benefit type 1 diabetes Key takeaways: - Time in range was similar with a fully closed-loop system delivering insulin lispro and pramlintide compared with insulin alone. - More trials are needed enrolling people with suboptimal time in range. NEW ORLEANS — Adults with type 1 diabetes had a similar time in range using automated insulin delivery with ultrarapid-acting insulin lispro-aabc and pramlintide compared with insulin lispro-aabc alone, according to a speaker. In findings from a randomized crossover trial presented at the American Diabetes Association Scientific Sessions, use of a fully closed-loop automated insulin delivery system that delivered both insulin lispro-aabc (Lyumjev, Eli Lilly) and pramlintide (Symlin, AstraZeneca) conferred similar glycemic outcomes and resulted in a lower daily insulin dose compared with insulin lispro-aabc with manual carbohydrate counting. According to Joelle Doumat, a graduate student at McGill University in Montreal, the closed-loop system included a Dexcom G6 continuous glucose monitor and two separate insulin pumps that allowed patients to receive insulin and pramlintide simultaneously. “When insulin is alone in these fully closed-loop systems, we see notable postprandial hyperglycemia, and that’s because of the delayed onset of action of insulin when it’s subcutaneously infused,” Doumat said during a presentation. “However, we have pramlintide, which helps attenuate postprandial glycemia, and that’s why we added it within this fully closed-loop system.” The trial included 26 adults with type 1 diabetes (mean age, 35 years; 69.2% women). Participants completed 3 weeks of each of the following arms: insulin lispro-aabc with pramlintide administered at a ratio of 8 mg for every 1 U of insulin, insulin lispro-aabc with pramlintide delivered at a ratio of 10 mg for every 1 U of insulin, and a control arm of insulin lispro-aabc plus placebo. The primary outcome was noninferiority in time in range of both insulin lispro-aabc with pramlintide groups compared with the control group. At 3 weeks, the insulin lispro-aabc plus pramlintide 1:8 group had a time in range of 71.1%, and the insulin lispro-aabc plus pramlintide 1:10 group had a time in range of 71.2% compared with a 72.1% time in range with insulin plus placebo. Both intervention groups conferred similar time in range as the control group, though Doumat said they failed to meet the trial’s noninferiority criteria. In an analysis of 10 adults who had a time in range of less than 70% during the control arm of the trial, time in range was higher with insulin lispro-aabc plus pramlintide compared with insulin lispro and manual carbohydrate counting (67.9% vs. 60.6%; P = .011). Doumat said it was interesting to see an improvement in time in range with the fully closed-loop system in this subgroup. “This is quite important because not only are they not having to carbohydrate count for all their meals and snacks, they are also experiencing significantly improved glycemic outcomes,” Doumat said. Time in hypoglycemia with glucose of less than 70 mg/dL was similar between the three groups. The insulin lispro-aabc with pramlintide 1:10 ratio group had a lower time in severe hypoglycemia with glucose of less than 54 mg/dL compared with the control group (0.3% vs. 0.1%; P = .008). Total daily insulin dose was 42.8 U with insulin lispro and pramlintide 1:8 and 41.3 U with insulin lispro and pramlintide 1:10 compared with 47.4 U for the control group (P < .001 for both). Gastrointestinal adverse events occurred among seven adults in the insulin lispro and pramlintide 1:8 arm and eight adults during the insulin lispro and pramlintide 1:10 arm compared with no adults in the control arm. Infusion site stinging was reported by 44% of adults in each of the intervention arms and 55% of those in the control arm. One severe adverse event occurred during the control arm that was unrelated to the study. Two adults dropped out of the study due to nausea linked to pramlintide. Doumat said longer trials assessing the fully closed-loop system that enroll a larger study population of people with suboptimal glycemic control are needed.