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

Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.

Registry: NCT03784027. Registered endpoint checked: Time in Target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl) (16-week home stay). Eligibility check: Registry age 1 Year to 7 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers' Fear of Hypoglycemia and Improves Their Well-Being.; 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.; Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.