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

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posted on 2023-10-24, 20:42 authored by Jordan S. Sherwood, Luz E. Castellanos, Mollie Y. O’Connor, Courtney A. Balliro, Mallory A. Hillard, Sarah Grace Gaston, Rachel Bartholomew, Evelyn Greaux, Amy Sabean, Hui ZhengHui Zheng, Peter Marchetti, Ahmet Z. Uluer, Gregory S. Sawicki, Isabel Neuringer, Firas H. El-Khatib, Edward R. Damiano, Steven J. Russell, Melissa S. Putman

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 cross-over trial (NCT #03258853).

Research Design and Methods: Twenty participants with CFRD were assigned in random-order to 14-days each on the BP or their usual diabetes 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 (TIR) on days 3-14 of each arm, and key secondary outcomes included mean 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 compared to the UC arm (75±11 versus 62±22%, p=0.001). Mean CGM glucose was lower in the BP arm than in the UC arm (150±19 mg/dL versus 171±45 mg/dL, p=0.007). There was no significant difference in percent time with sensor-measured glucose <54 mg/dL (0.27% versus 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 hypoglycemia with the BP compared to their UC, suggesting this may be an important therapeutic option for this patient population.

Funding

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK grants 1R01DK119699-01 and T32DK007028). Investigators on this study (M.S.P. and J.S.S.) received support from the Cystic Fibrosis Foundation (Harry Shwachman Clinical Investigator Award, EnVision CF: Emerging Leaders in CF Endocrinology II Program, and Clinical Research Scholars Program). Dexcom supplied discounted continuous glucose monitoring devices and sensors for the study.

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