To determine if the bihormonal bionic
pancreas (BHBP) improves glycemic control and reduces hypoglycemia in
individuals with congenital hyperinsulinism (HI) and post-pancreatectomy
diabetes (PPD) compared with usual care (UC).
Methods: Ten subjects with HI and PPD completed
this open-label, crossover pilot study. Co-primary outcomes were mean glucose concentration
and time with continuous glucose monitoring (CGM) glucose concentration <3.3
Results: Mean (SD) CGM glucose concentration was
8.3 mmol/L (0.7) in the BHBP period vs. 9 mmol/L (1.8) in the UC period (p=0.13).
Mean (SD) time with CGM glucose concentration <3.3 mmol/L was 0% (0.002) in
the BHBP period vs. 1.3% (0.018) in the UC period (p=0.11).
Relative to UC, the BHBP resulted in comparable glycemic control in our
The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the manuscript. A.R.’s research training was supported by the CHOP Pediatric Endocrinology Division T32 grant (T32DK063688) in 2017-2018 and the Pediatric Endocrinology Society Research Fellowship Award in 2018-2019. This study was funded by grants to D.D.D.L. from Zealand Pharma A/S, the Orphan Disease Center at the University of Pennsylvania, the Children’s Hospital of Philadelphia Women’s Committee, and the Center for Human Phenomic Science at the Children’s Hospital of Philadelphia (NCATS award UL1TR001878). Dexcom Inc. supported the study by providing the CGMS used in the study.