NCT02727231

Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to determine whether day and night closed-loop insulin delivery for 4 weeks under free living conditions is superior to usual insulin pump therapy in adults with type 1 diabetes and HbA1C\<7.5%. This is an open-label, multi center, randomized, crossover design study, involving a 2-4 week run-in period, followed by two 4 weeks study periods during which glucose levels will be controlled either by an automated day- and night closed-loop system or by subjects usual insulin pump therapy in random order. A total of up to 34 adults (aiming for 24 completed subjects) aged 18 years and older with T1D on insulin pump therapy and HbA1C\<7.5% will be recruited through diabetes clinics and other established methods in participating centers. Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes are time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Florence D2A or similar closed loop glucose control system	Subject's glucose level will be controlled by the Florence D2A or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator 2 ® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), Dana R Diabecare subcutaneous insulin infusion pump (Sooil Corp. Seoul, South Korea)or similar insulin pump, and MPC-based glucose control algorithm running on a smartphone
DEVICE	CSII with CGM	Subject glucose level controlled by usual insulin pump therapy in conjunction with continuous glucose monitoring (CGM)

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-04-04
• Last updated: 2016-10-11

Locations

2 sites across 2 countries: Austria, United Kingdom