ISSN 1662-4009 (online)

ESPE Yearbook of Paediatric Endocrinology (2022) 19 2.6 | DOI: 10.1530/ey.19.2.6

ESPEYB19 2. Antenatal and Neonatal Endocrinology Neonatal hypoglycaemia (8 abstracts)

2.6. The bihormonal bionic pancreas improves glycemic control in individuals with hyperinsulinism and postpancreatectomy diabetes: a pilot study

Rayannavar A , Mitteer LM , Balliro CA , El-Khatib FH , Lord KL , Hawkes CP , Ballester LS , Damiano ER , Russell SJ & De León DD



Diabetes Care. 2021 Nov;44(11):2582-2585. doi: 10.2337/dc21-0416. PMID: 34518377.

Brief Summary: This pilot study, in patients with post-pancreatectomy diabetes due to congenital hyperinsulinism, assessed pump-delivered insulin and glucagon (Bihormonal Bionic Pancreas, BHBP) to regulate blood glucose levels. BHBP controlled post-prandial glucose levels better than a conventional insulin pump but further studies are needed.

Patients with diffuse congenital hyperinsulinism may require a near-total pancreatectomy if they are unresponsive to medical treatment. The near-total pancreatectomy eventually leads to post-pancreatectomy diabetes (PPD). This type of PPD is associated with insulin and glucagon deficiency. The bi-hormonal bionic pancreas (BHBP, a type of pump) has been shown to improve glycemic control and to reduce the frequency of hypoglycemia in individuals with type 1 diabetes by autonomously administering insulin and glucagon based on plasma glucose levels detected via continuous glucose monitoring (CGM) system (1).

This open-label, randomized crossover pilot study compared current standard diabetes care (using the standard insulin pump) with the BHBP to reduce the mean glucose concentration and the fraction of time with glucose concentrations <3.3 mmol/L in patients with PPD. Although the authors conclude that the use of the BHBP may be better suited for post-prandial glycaemia in individuals with congenital hyperinsulinism than current conventional insulin pump therapy, there are several limitations.

The key limitation is that the study only involved 10 patients and this small sample size had limited ability to demonstrate statistically significant differences in the outcomes. There were no significant differences in the main outcomes between the standard care and the BHBP. Larger and longer studies using the newer BHBP device will need to be undertaken in this population to establish the long-term benefit and risks of the BHBP.

Reference: 1. Russell SJ, El-Khatib FH, Sinha M, Magyar KL, McKeon K, Goergen LG, Balliro C, Hillard MA, Nathan DM, Damiano ER. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014 Jul 24;371(4):313–325. doi: 10.1056/NEJMoa1314474. Epub 2014 Jun 15. PMID: 24931572; PMCID: PMC4183762.