Volledige closed loop glucoseregulatie; bewijs en ervaring in het dagelijkse leven

The safety and performance of a bi-hormonal closed loop system for automated glucose control in patients with type 1 diabetes (artificial pancreas (AP); Inreda Diabetic B.V.) has been demonstrated in previous clinical studies (APPEL 4 and 5). In these studies time in range (TIR; 3.9–10.0 mmol/l) improved during closed loop treatment compared to insulin pump therapy. The clinical data from these studies facilitated CE-marking of the Inreda AP. However, real-world data with regards to the performance, safety and the use of the AP for a longer period of time is not known. The main objective of this multicenter, prospective, observational study is to assess long-term performance and obtain real-world experience with the AP in 75 type 1 diabetes patients over 1 year. The secondary objectives are to examine long-term safety of the AP system, treatment adherence, to asses patient reported outcomes measures, and to explore AP related outcomes.

No predetermined hypothesis

For the primary analysis, the endpoints at month 12 will be used (for continuous data calculated over the preceding 3-month interval). Endpoints based on AP data will be calculated over 3-month intervals exactly after the start of the AP treatment. PROMs will be collected at baseline and 3, 6, 9 and 12 months after the AP treatment start.