Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis– Related Diabetes

作者：Jordan S. Sherwood, Luz E. Castellanos, Mollie Y. O’Connor, COURTNEY A. BALLIRO, Mallory Hillard, Sarah Gaston, Rachel Bartholomew, Evelyn Greaux, Amy Sabean, Hui Zheng, Peter Marchetti, Ahmet Uluer, G. Sawicki, Isabel P. Neuringer, Firas H. El-Khatib, Edward R. Damiano, Steven J. Russell, Melissa S. Putman · 发表于：Diabetes Care · 年份：2023 · DOI：10.2337/dc23-1411 · 被引用次数：20 · 研究领域：Diabetes Management and Research、Cystic Fibrosis Research Advances、Pancreatic function and diabetes

OBJECTIVE: Cystic fibrosis-related diabetes (CFRD) affects up to 50% of adults with cystic fibrosis and adds significant morbidity and treatment burden. We evaluated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas (BP) in adults with CFRD in a single-center, open-label, random-order, crossover trial. RESEARCH DESIGN AND METHODS: Twenty participants with CFRD were assigned in random order to 14 days each on the BP or their usual care (UC). No restrictions were placed on diet or activity. The primary outcome was the percent time sensor-measured glucose was in target range 70-180 mg/dL (time in range [TIR]) on days 3-14 of each arm, and key secondary outcomes included mean continuous glucose monitoring (CGM) glucose and the percent time sensor-measured glucose was in hypoglycemic range <54 mg/dL. RESULTS: TIR was significantly higher in the BP arm than the UC arm (75 ± 11% vs. 62 ± 22%, P = 0.001). Mean CGM glucose was lower in the BP arm than in the UC arm (150 ± 19 vs. 171 ± 45 mg/dL, P = 0.007). There was no significant difference in percent time with sensor-measured glucose <54 mg/dL (0.27% vs. 0.36%, P = 1.0), although self-reported symptomatic hypoglycemia episodes were higher during the BP arm than the UC arm (0.7 vs. 0.4 median episodes per day, P = 0.01). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either arm. CONCLUSIONS: Adults with CFRD had improved glucose control without an increase in CGM-measured hyp...