Background The objective of this paper was to use the Alert-HTA methodology to evaluate an emerging technology (iLet™ Bionic Pancreas or closed loop). This device, not yet on the market, is indicated in the control of blood glucose in patients with type 1 diabetes mellitus.

Materials and Methods The investigation PICO has been defined for the research strategy. A search of the scientific literature has been carried out through the PubMed and Embase engines. The articles of interest were identified through selection criteria related to the objective of the report and then subjected to checklists (SIGN) for the qualitative evaluation of the sources. The CITAVI tool was used to facilitate the analysis of the literature used. 

Results The results regarding the safety and efficacy of the Bionic Pancreas have shown significant advantages compared to the standard methods considered as comparators (Continuous Subcutaneous Insulin Infusion - CSII and Sensor Augmented Pump therapy - SAP). In particular, a decrease in episodes of hypoglycemia, mainly at night, and an increase in time in the optimal range of blood glucose values. The therapy with iLet™ can be considered a further step forward in closed loop systems for its characteristics of integration into a single device (miniaturization of the system) with the possibility of using insulin and glucagon for a more physiological regulation of blood glucose.

Conclusions At the moment the data are still to be considered insufficient for a possible approval by FDA. There is still a component of uncertainty regarding safety due to problems with the infusion set and the stability of glucagon. The use of the Bionic Pancreas by patients requires strong motivation and an important training impact that also involves the caregiver. Currently, the costs of providing this new technology are higher than traditional therapy but the saving obtained with the reduction of complications will have to be considered. However, further studies are needed that also take into account the following parameters: more patients enrolled, longer study duration, real-life experience and cost-effectiveness assessments.

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Key words: Alert HTA, Bionic pancreas, Insulin, Glucagone, Glucose