|
The KidsAP02 trial
The KidsAP02 trial was conducted at seven clinical sites across Europe (Cambridge, Leeds, Luxembourg, Leipzig, Vienna, Innsbruck and Graz). Seventy‐four children were recruited: All were aged 1–7 years, had lived with type 1 diabetes for at least 6 months and used an insulin pump for at least 3 months. Children were randomised to use, initially, either a hybrid closed‐loop system (the intervention arm) or sensor‐augmented pump therapy (the control arm). After 16 weeks using the first system, and a ‘wash‐out’ period, they began using the other. The same component devices (pump, CGM sensor and smartphone) and app were used by participants in both arms of the trial.
The CamAPS FX hybrid closed‐loop system (CamDiab, Cambridge, UK)
The CamAPS FX is a ‘hybrid’ closed‐loop system, calculating and delivering basal (background) insulin automatically, but requiring the user to administer boluses to cover meals/food. CamAPS FX comprises the following devices/components:
DANA RS insulin pump (Sooil, Seoul, South Korea);
Dexcom G6 factory‐calibrated real‐time CGM sensor (Dexcom, San Diego, CA, USA), with CGM transmitter;
An unlocked Android smartphone (Galaxy S8, Samsung, South Korea) running Android 8 OS or above, hosting the CamAPS FX app incorporating the Cambridge model predictive control algorithm (CamDiab, Cambridge, UK). The smartphone/app communicates wirelessly with both the sensor and insulin pump, subject to being kept within 5–10 m of these devices.
The CamAPS FX App
In addition to being used to administer meal‐time boluses, the app includes functions enabling (parents of) users to:
view ‘real‐time’ and retrospective graphs displaying glucose levels, rate of insulin delivery, meal‐time boluses and carbohydrate intake, high/low glucose range, glucose trend arrows and indicators of whether the closed‐loop is/was operational (Auto mode on) or interrupted/switched off (Auto mode off). [Note: In the sensor‐augmented pump therapy, arm of the trial ‘Auto mode’ was not switched on; hence, the hybrid closed‐loop system was not activated in this phase and rates/times of basal insulin delivery were instead preset.] view summary statistics for daily, weekly, monthly or 3‐monthly periods, including: average glucose, estimated HbA1c, time in/below/above target, number and average duration of hypoglycaemias, total daily dose/bolus/basal insulin; and percentage of time in Auto mode (for those using the hybrid closed‐loop). personalise alarms triggered by high/low‐glucose levels and signal loss with the sensor and/or pump. (Parents of) users can also adjust the threshold, repeat time, audio sound or vibration which accompanies an on‐screen display, and turn on/off all alarms (except for the ‘Urgent Low’ glucose alarm).
Remote monitoring capabilities
The app automatically facilitates data upload to the cloud, thus enabling remote monitoring, that is, the sharing of data with parents/carers (and, moreover, health professionals—a practice we will discuss in a further/separate paper). Remote monitoring additionally requires the use of:
One or more other smartphones with the Diasend diabetes management system app (Glooko/Diasend, Göteborg, Sweden) installed, via which parents/carers can view near ‘real‐time’ glucose levels, rate of insulin delivery and meal‐time bolus data. A SIM card installed in the study smartphone, enabling alarms activated on the CamAPS FX app and pump to be relayed to designated ‘followers’ (registered on the app) who receive SMS text alerts mirroring notifications of out‐of‐range glucose levels, signal loss etc. set on the app/pump.
|
