The Bihormonal Bionic Pancreas Improves Glycemic Control in Individuals With Hyperinsulinism and Postpancreatectomy Diabetes: A Pilot Study

Arpana Rayannavar, Lauren M Mitteer, Courtney A Balliro, Firas H El-Khatib, Katherine L Lord, Colin P Hawkes, Lance S Ballester, Edward R Damiano, Steven J Russell, Diva D De León, Arpana Rayannavar, Lauren M Mitteer, Courtney A Balliro, Firas H El-Khatib, Katherine L Lord, Colin P Hawkes, Lance S Ballester, Edward R Damiano, Steven J Russell, Diva D De León

Abstract

Objective: To determine whether the bihormonal bionic pancreas (BHBP) improves glycemic control and reduces hypoglycemia in individuals with congenital hyperinsulinism (HI) and postpancreatectomy diabetes (PPD) compared with usual care (UC).

Research design and methods: Ten subjects with HI and PPD completed this open-label, crossover pilot study. Coprimary outcomes were mean glucose concentration and time with continuous glucose monitoring (CGM) glucose concentration <3.3 mmol/L.

Results: Mean (SD) CGM glucose concentration was 8.3 (0.7) mmol/L in the BHBP period versus 9 (1.8) mmol/L 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).

Conclusions: Relative to UC, the BHBP resulted in comparable glycemic control in our population.

Trial registration: ClinicalTrials.gov NCT03303196.

© 2021 by the American Diabetes Association.

Figures

Figure 1
Figure 1
Comparison of mean CGM glucose concentration and frequency of hypoglycemia (

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Source: PubMed

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