The main objective of this open-label, multi-centre, randomised, crossover design study is to determine whether automated day and night closed-loop insulin delivery for 16 weeks under free living conditions is safer and more efficacious compared to sensor augmented insulin pump therapy in older adults with type 1 diabetes. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L (70 and 180 mg/dl) as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of human factor assessments, cardiac arrhythmias and objective sleep quality assessment will also be evaluated in this study.
No study thus far has specifically evaluated use of closed-loop insulin delivery in older adults with type 1 diabetes. During our previous closed-loop studies, if there is a communication failure between the algorithm device and the insulin pump, the pump is set to deliver pre-programmed basal insulin rates after about 30 to 60 minutes.The main objective of this study is to determine whether automated day and night closed-loop insulin delivery for 16 weeks under free living conditions is safer and more efficacious compared to sensor augmented insulin pump therapy in older adults with type 1 diabetes. This is an open-label, multi-centre, randomised, crossover design study, involving a 4-6 week run-in period, followed by two 4 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by sensor-augmented pump therapy in random order. A total of up to 42 adults (aiming for 36 completed subjects) aged 60 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 6 weeks of the first intervention period will be replaced. 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 (70 and 180mg/dl) as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of human factor assessments, cardiac arrhythmia and objective sleep quality assessment will also be evaluated in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Hybrid closed-loop system
Sensor augmented pump therapy
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Proportion of Time Spent in the Target Sensor Glucose Range During the 16 Week Intervention Period (%)
Proportion of time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on continuous glucose monitoring (CGM)
Time frame: 16 weeks
HbA1c at the End of the 16 Week Intervention Period (mmol/Mol)
Time frame: 16 weeks
Proportion of Time Spent Below Target Glucose (3.9mmol/l) (70mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks
Proportion of Time Spent Above Target Glucose (10.0 mmol/l) (180 mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks
Average (mmol/L) of CGM Glucose Levels During the 16 Week Intervention Period
Time frame: 16 weeks
Proportion of Time With Glucose Levels < 3.5 mmol/l (63mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks
Proportion of Time With Glucose Levels in the Significant Hyperglycaemia (Glucose Levels > 16.7 mmol/l) (300mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks
Total Daily Insulin Dose During the 16 Week Intervention Period (Units/Day)
Time frame: 16 weeks
Standard Deviation (mmol/L) of CGM Glucose Levels During the 16 Week Intervention Period
Time frame: 16 weeks
Proportion of Time With Glucose Levels < 3.0 mmol/l (54mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks
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