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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
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
Subject glucose level controlled by usual insulin pump therapy in conjunction with continuous glucose monitoring (CGM)
Medical University of Graz
Graz, Austria
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom
Time spent in the target glucose range (3.9 to 10.0 mmol/l) based on subcutaneous glucose monitoring
Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) during the 4 weeks of home stay. Intention to treat basis.
Time frame: 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome
Time spent above and below the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) during the 4 weeks of home stay. Intention to treat basis.
Time frame: 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome
Average,standard deviation and coefficient of variation of glucose levels during 4 weeks of home periods
Time frame: 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome
The time with glucose levels \< 3.5 mmol/l and \<2.8 mmol/l during 4 weeks of home periods
Time frame: 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome
The time with glucose levels in the significant hyperglycaemia,(glucose levels \> 16.7 mmol/l during 4 weeks of home periods
Time frame: 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome
Low Blood Glucose Index
Time frame: 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome
The "Area Under the Curve" below 3.5 mmol/l during 4 weeks home periods
Time frame: 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome
Between 24 hour period variability: Coefficient of variation of CGM glucose between 24 hour periods (midnight to midnight)
Time frame: 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome during overnight period between 24:00 and 06:00
Time spent with CGM glucose concentration in range 3.9-10.0mmol/L
Time frame: 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome during day period between 06:00 to 24:00
Time spent with CGM glucose concentration in the target range (3.9-10.0mmol/L)
Time frame: 4 weeks
Insulin dose
Total, basal and bolus insulin dose during 4 weeks of home periods
Time frame: 4 weeks
Adverse Events
Safety evaluation will comprise the number of episodes of hypoglycaemia, significant ketonemia (\> 3.0mmol/l)as well as nature and severity of any other adverse events
Time frame: 5 months
Utility Evaluation
Utility evaluation is the percentage of closed-loop operation time during use at home, and when CGM was available
Time frame: 4 weeks
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