The bihormonal bionic pancreas (BP) reduced both mean CGM glucose (CGMG) and time in the hypoglycemic range relative to usual care in outpatient studies. We recently performed an outpatient study in which we compared insulin-only (IOBP) and bihormonal (BHBP) configurations of the BP with usual care (UC; conventional or sensor-augmented insulin pump therapy) both with and without remote monitoring. We previously reported that monitoring did not affect the mean CGMG or hypoglycemia with either configuration of the BP. The current analysis focuses on the data collected from arms without remote monitoring (how the BP is eventually meant to be used) to determine how the effects of the BP differ between the day and night. As shown in the Table, both the IOBP (with glucose target of 110 mg/dl) and BHBP (with glucose target of 100 mg/dl) significantly reduced mean CGMG vs. UC during both the daytime and nighttime. In contrast, only the BHBP significantly reduced the percent of time spent with CGMG <60 mg/dl vs. UC. The BHBP similarly reduced percent of time <60 mg/dl vs. IOBP. The significant reductions in hypogycemia associated with the BHBP were driven primarily by reductions in hypoglycemia at night.


J. Sherwood: None. C.A. Balliro: None. R.Z. Jafri: None. F. El-Khatib: Stock/Shareholder; Self; Beta Bionics. Employee; Self; Beta Bionics. M. Maheno: None. M.A. Hillard: None. A.J. O'Donovan: None. R. Selagamsetty: None. H. Zheng: None. E. Damiano: Other Relationship; Self; Beta Bionics. S.J. Russell: Other Relationship; Self; Beta Bionics, Novo Nordisk Inc.. Advisory Panel; Self; Companion Medical, Tandem Diabetes Care, Inc., Unomedical a/s. Research Support; Self; Beta Bionics, Zealand Pharma A/S, MITRE Corporation.

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