CamAPS FX vs Sensor Augmented Pump Therapy.
The Tauschmann et al study ‘Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial’ published in the Lancet 2018; 392: 1321–29 compares the use of the CamAPS FX hybrid closed loop system to sensor augmented pump therapy.
It is important to note that the comparative system is sensor augmented pump therapy, rather than standard pump therapy. It is well documented that insulin pump therapy health benefits are already improved with sensor augmentation over standard insulin pump therapy where blood glucose data is provided by finger sticks tests at certain points in a users day.
The study is available to read in full here: http://dx.doi.org/10.1016/S0140-6736(18)31947-0
Over 12 weeks of free living, subjects were randomly provided either the CamAPS FX hybrid closed loop system or sensor augmented pump therapy. Subjects were over the age of 6 years old with sub-optimally controlled blood glucose. The primary endpoint was the proportion of time that glucose concentration was within the target range of 3·9–10·0 mmol/L at 12 weeks post randomisation.
The proportion of time that glucose concentration was within the target range was significantly higher in the closed-loop group (65%, SD 8) compared with the control group (54%, SD 9).
In the closed-loop group, HbA1c was reduced from a screening value of 8·3% (SD 0·6) to 7·4% (SD 0·6) after the 12-week intervention period. In the control group, the HbA1c values were 8·2% (SD 0·5) at screening and 7·7% (SD 0·5) after intervention; reductions in HbA1c percentages were significantly greater in the closed-loop group compared with the control group.
The time spent with glucose concentrations below 3·9 mmol/L (mean difference in change –0·83 percentage points, –1·40 to –0·16; p=0·0013) and above 10·0 mmol/L (mean difference in change 10·3 percentage points, –13·2 to –7·5; p<0·0001) was shorter in the closed-loop group than the control group.
Hybrid closed-loop insulin delivery improves glucose control while reducing the risk of hypoglycaemia across a wide age range in patients with suboptimally controlled type 1 diabetes.