The use of closed loop technology in the management of type 1 diabetes has advanced rapidly in the last five years from early investigational devices to a pre-commercial fully integrated system.
To describe the clinical research nurse experience and contribution in the evolution and transition from early closed loop insulin delivery devices used in-clinic and at-home studies, progressing towards the development of a fully integrated system.
Retrospective review of four closed loop studies conducted at Princess Margaret Hospital, from 2010 to 2015. The adjustment of study designs with improvements in the technology and the research nurse involvement with technical and participant monitoring.
Initial closed loop studies began with 8 hour overnight studies and progressed to 5 days, 24 hour at-home studies (N=8-18 participants/study). Initial systems involved multiple devices: two real-time continuous glucose monitoring (RTCGM) sensors with transmitters, translator, smartphone and insulin pump advancing to an integrated system (insulin pump and RTCGM sensor). In early studies, research nurses were required to intensively monitor blood glucose levels and sensor readings. The latest outpatient study utilized a closed loop system, requiring 15-minute remote monitoring, regular phone contact with participants and technical troubleshooting. Closed loop insulin delivery has progressed from a 45-minute initiation in early studies, to 5 minutes in recent studies using a fully integrated system.
With our growing confidence in the safety of the system and refinement of the technology, we have progressed from intensely supervised in-clinic studies to at-home studies. Long term unmonitored home trials are planned. Clinical research nurses play a vital role in the safe and successful running of studies, together with the provision of feedback to industry and the diabetes healthcare team on efficacy, usability and patient acceptability.