CamAPS FX hybrid closed-loop in very young children (1-7y): the KidsAP02 crossover trial

What was tested, and why it matters

Managing type 1 diabetes in toddlers and preschoolers is uniquely hard. Very young children eat unpredictably, can't describe how they feel, and are extremely sensitive to tiny insulin doses — so caregivers face constant glucose swings, frequent low blood sugars, and round-the-clock vigilance that disrupts the whole family's sleep and wellbeing.¹ The KidsAP02 trial asked whether an "artificial pancreas" — a system that automatically adjusts insulin minute-by-minute — could do better than the usual approach in this age group.²

Who it was for

The trial enrolled children aged 1 to 7 years (2 to 7 in Germany and the UK) who had had type 1 diabetes for at least six months and were already using an insulin pump.¹ A total of 74 children were randomized; their average age was 5.6 years and average starting HbA1c was 7.3%.²

How it was designed

This was an open-label, randomized, multinational crossover study run at seven centres across Austria, Germany, Luxembourg and the United Kingdom.² Each child used both treatments, in random order, for 16 weeks each: the CamAPS FX hybrid closed-loop system (a Dana RS insulin pump and Dexcom G6 sensor linked to an Android phone running the Cambridge control algorithm) versus a sensor-augmented pump, where the family still makes all the insulin decisions.¹ The main measure was the share of time glucose stayed in the target range of 70-180 mg/dL (3.9-10.0 mmol/L).²

Key results

Closed-loop control clearly came out ahead. Time-in-range was 8.7 percentage points higher with the artificial pancreas (95% CI 7.4 to 9.9) — roughly two extra hours per day in range.² Time spent high (above 180 mg/dL) fell by 8.5 points, HbA1c dropped by 0.4 points, and average glucose fell by 12.3 mg/dL (about 0.7 mmol/L).² Crucially, time spent low — the thing parents fear most — was no different between the two systems, so the gains did not come at the cost of more hypoglycemia.² The system ran automatically 95% of the time, and only one severe low-glucose event occurred during the closed-loop period, with no ketoacidosis.² A companion analysis found caregivers also reported less fear of hypoglycemia and better wellbeing on closed-loop.³

What it means and what's next

Published in the New England Journal of Medicine in 2022, KidsAP02 is among the strongest evidence that hybrid closed-loop is both effective and safe for the youngest children with type 1 diabetes.² It helped support wider use of CamAPS FX down to age 1, and an extension phase followed families using the system long-term at home.¹

References

1. Fuchs J, Allen JM, Boughton CK, et al. Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol. BMJ Open (2021). https://doi.org/10.1136/bmjopen-2020-042790 ↩ ↩² ↩³ ↩⁴

2. Ware J, Allen JM, Boughton CK, et al. Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes. N Engl J Med (2022);386(3):209-219. https://doi.org/10.1056/NEJMoa2111673 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹

3. de Beaufort C, Schierloh U, Thankamony A, et al. Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers' Fear of Hypoglycemia and Improves Their Well-Being. Diabetes Care (2022);45(12):3050-3053. https://doi.org/10.2337/dc22-0693 ↩