From In- to Out-patient Artificial Pancreas Studies: Results And New Developments

The Artificial Pancreas (AP) is a device for closed-loop modulation of insulin infusion, aiming to maintain patient glycemia in a nearly normal range. In the last decade AP prototypes using subcutaneous glucose sensing and subcutaneous insulin delivery have been extensively studied in clinical trials involving hospitalized patients. To ensure the highest level of patient safety, these studies usually employed very structured protocols and subcutaneous glucose measurements were accompanied by frequent and accurate blood glucose measurements via intravenous sampling. Therefore, in-patient studies were usually short and patients were often unable to move freely. The next step in the AP development is testing safety and efficacy of AP in a real-life scenario, outside the hospital environment and free of strict protocol prescriptions. This paper offers a review of some technological and algorithmic challenges posed by the in-to out-patient transition and reports the authors' experience in making this transition possible. Issues related to devices, telemedicine and control algorithms are discussed and outpatient clinical results are presented in support.