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

Author:

Sherwood Jordan S.1,Castellanos Luz E.1,O’Connor Mollie Y.1,Balliro Courtney A.12,Hillard Mallory A.12,Gaston Sarah Grace1,Bartholomew Rachel1,Greaux Evelyn1,Sabean Amy1,Zheng Hui3,Marchetti Peter4,Uluer Ahmet45,Sawicki Gregory S.4,Neuringer Isabel6,El-Khatib Firas H.2,Damiano Edward R.27,Russell Steven J.12,Putman Melissa S.18ORCID

Affiliation:

1. 1Diabetes Research Center, Massachusetts General Hospital, Boston, MA

2. 2Beta Bionics Inc., Concord, MA

3. 3Biostatics Center, Massachusetts General Hospital, Boston, MA

4. 4Division of Pulmonary Medicine, Boston Children’s Hospital, Boston, MA

5. 5Division of Pulmonology, Brigham and Women’s Hospital, Boston, MA

6. 6Division of Pulmonology and Critical Care, Massachusetts General Hospital, Boston, MA

7. 7Department of Biomedical Engineering, Boston University, Boston, MA

8. 8Department of Endocrinology, Boston Children’s Hospital, Boston, MA

Abstract

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 hypoglycemia with the BP compared with their UC, suggesting that this may be an important therapeutic option for this patient population.

Funder

Cystic Fibrosis Foundation

National Institute of Diabetes and Digestive and Kidney Diseases

Publisher

American Diabetes Association

Subject

Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine

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