The main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over an 8 week period in adults with type 2 diabetes (T2D). This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 1 diabetes in the home setting, and in adults with type 2 diabetes in the inpatient setting. This is an open-label, single centre, randomised, cross-over study, involving two home study periods during which glucose levels will be controlled either by a fully automated closed-loop system or by participants' usual insulin therapy in random order. Each treatment arm is 8 weeks long with a 2-4 week washout period between treatments. A total of up to 30 participants with T2D will be recruited through outpatient clinics to allow for 24 completed participants available for assessment. Participants will receive appropriate training by the research team on the safe use of the study devices (insulin pump and continuous glucose monitoring (CGM) and closed-loop insulin delivery system). Participants in the control arm will continue with standard therapy and will wear a blinded CGM system. The primary outcome is time spent with glucose levels in the target range between 3.9 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics in addition to insulin requirements. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The CamAPS HX closed-loop system comprises: Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) An Android smartphone hosting CamAPS HX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data.
Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Time in the target glucose range (3.9 to 10.0 mmol/l)
Percentage of time spent with sensor glucose readings in the target range from 3.9 to 10.0mmol/l
Time frame: 8 week intervention period
Time spent above target glucose (10.0 mmol/l)
Percentage of time spent with sensor glucose readings above target glucose (10.0 mmol/l)
Time frame: 8 week intervention period, both arms
Mean glucose
Mean sensor glucose level
Time frame: 8 week intervention period, both arms
Time spent in hypoglycaemia (<3.9 mmol/l)
Percentage of time spent with sensor glucose readings \<3.9 mmol/L
Time frame: 8 week intervention period, both arms
Standard deviation of glucose levels
Standard deviation of glucose levels
Time frame: 8 week intervention period, both arms
Coefficient of variation of glucose levels
Coefficient of variation of glucose levels
Time frame: 8 week intervention period, both arms
Time spent below <3.0 mmol/l
Percentage of time spent with sensor glucose readings \<3.0 mmol/l
Time frame: 8 week intervention period, both arms
Time in hyperglycaemia > 16.7 mmol/l
Percentage of time with glucose levels in hyperglycaemia \> 16.7 mmol/l
Time frame: 8 week intervention period, both arms
Time in significant hyperglycaemia (> 20 mmol/l)
Percentage of time with glucose levels in significant hyperglycaemia (\> 20 mmol/l)
Time frame: 8 week intervention period, both arms
Glycated haemoglobin (HbA1c)
HbA1c measured at the end of each study period
Time frame: 8 week intervention period, both arms
Total insulin dose
Average daily total insulin requirements
Time frame: 8 week intervention period, both arms
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