Background and Aims

Glucose control in patients with diabetes after total pancreatectomy (TP) is problematic due to complete absence of both pancreatic alpha and beta cells. Recently, a novel bihormonal (insulin and glucagon) artificial pancreas (AP) for closed loop glucose control showed better glucose control compared to standard insulin pump therapy in patients with diabetes type 1. This AP system might also improve glucose control in patients after TP.

The aim is to assess the efficacy and safety of the bihormonal AP in patients after TP.

Methods

This trial was an outpatient, randomized, crossover trial comparing AP therapy to current care (insulin pump or pen therapy). The outcomes in both phases were analyzed during a total of 7 days. The AP closed loop phase was preceded by a 5-day training period. Primary outcome was the time spent in euglycemia (3.9-10 mmol/L or 70–180 mg/dL).

Results

A total of 10 patients were included in the analysis. In the AP closed loop phase, the time spent in euglycemia was significantly higher (78.3% [IQR 72.3-81.7] vs 57.4% [IQR 54.1-80.2], p=0.027), as compared to current care. Also, the AP showed a significant lower time spent in hypoglycemia (0% [IQR 0.0-0.0] vs 1.6% [IQR 1.0-2.8]), p=0.004). No serious adverse events related to the AP device were seen.

Conclusions

This small randomized crossover trial showed that an artificial pancreas bihormonal closed loop system is safe and significantly improves time in euglycemia as compared to current practice of insulin pump or pen injections. Larger randomized trials including longer periods of treatment are needed.