Despite significant improvements in the care of type 1 diabetes, achieving tight glycemic control while avoiding hypoglycemia 1,2 remains a challenge for many patients and novel therapeutic approaches are required. Closed-loop insulin delivery is an emerging treatment option for patients with type 1 diabetes. 3 Compared to preprogrammed basal insulin rates in insulin pumps, closed-loop insulin delivery systems modulate insulin delivery in glucose-responsive fashion based on subcutaneous sensor glucose levels utilizing advanced computer algorithms. 3Several studies have evaluated the safety and efficacy of closed-loop under laboratory conditions and shown promising results. These include evaluations using a randomized design by our group in youths, 4,5 adults, 6 and pregnant women 7 and by others using the model predictive control algorithm, 8,9 , the proportional-integral-derivative approach, 10,11 and the fuzzy logic controller. 12,13 Insulin and glucagon coadministration have also been applied in randomized studies.14-16 Several of above studies [4][5][6][7] were conducted in the manual operational mode where sensor glucose values were entered into a laptop computer running the algorithm followed by manual adjustment of the insulin pump. More recently automated closed-loop control systems utilizing an ultra-portable laptop computer 17 or mobile phone platform 18 have also been described. In February 2010, the European Union granted funding for the AP@home project (Artificial Pancreas at Home), a consortium of European academic medical centers, biotechnology companies, and industrial partners, to carry out closed-loop glucose control research. 19 The ultimate goal of the AP@home project is to develop a closed-loop system for use outside clinical research centers. The primary objective of the current study was to evaluate the reliability of the first , on behalf of the AP@home consortium AbstractThe objective was to assess the reliability of a novel automated closed-loop glucose control system developed within the AP@home consortium in adults with type 1 diabetes. Eight adults with type 1 diabetes on insulin pump therapy (3 men; ages 40.5 ± 14.3 years; HbA1c 8.2 ± 0.8%) participated in an open-label, single-center, single-arm, 12-hour overnight study performed at the clinical research facility. A standardized evening meal (80 g CHO) accompanied by prandial insulin boluses were given at 19:00 followed by an optional snack of 15 g at 22:00 without insulin bolus. Automated closed-loop glucose control was started at 19:00 and continued until 07:00 the next day. Basal insulin delivery (Accu-Chek Spirit, Roche) was automatically adjusted by Cambridge model predictive control algorithm, running on a purpose-built embedded device, based on real-time continuous glucose monitor readings (Dexcom G4 Platinum). Closed-loop system was operational as intended over 99% of the time. Overnight plasma glucose levels (22:00 to 07:00) were within the target range (3.9 to 8.0 mmol/l) for 75.4% (37.5, 92.9) of the time without any ti...

Diabetes patients are increasingly using a continuous glucose sensor to monitor blood glucose and an insulin pump connected to an infusion cannula to administer insulin. Applying these devices requires two separate insertion sites, one for the sensor and one for the cannula. Integrating sensor with cannula to perform glucose sensing and insulin infusion through a single insertion site would significantly simplify and improve diabetes treatment by reducing the overall system size and the number of necessary needle pricks. Presently, several research groups are pursuing the development of combined glucose sensing and insulin infusion devices, termed single-port devices, by integrating sensing and infusion technologies created from scratch. Methods: Instead of creating the device from scratch, we utilized already existing technologies and introduced three design concepts of integrating commercial glucose sensors and infusion cannulas. We prototyped and evaluated each concept according to design simplicity, ease of insertion, and sensing accuracy. Results: We found that the best single-port device is the one in which a Dexcom sensor is housed inside a Medtronic cannula so that its glucose sensitive part protrudes from the cannula tip. The low degree of component modification required to arrive at this configuration allowed us to test the efficiency and safety of the device in humans. Conclusion: Results from these studies indicate the feasibility of combining commercial glucose sensing and insulin delivery technologies to realize a functional single-port device. Significance: Our development approach may be generally useful to provide patients with innovative medical devices faster and at reduced costs.