Continuous Glucose Monitoring and Automated Insulin Delivery in Infants with Type 1 Diabetes: Real-World Evidence to Support Future International Guidelines

To evaluate efficacy and safety of continuous glucose monitoring (CGM) and automated insulin delivery (AID) in infants. A retrospective multicenter study (13 centers) of 76 children diagnosed with antibody-positive type 1 diabetes before age 2. Outcomes at 12 months were compared between AID users ( n = 47) and multiple daily injections (MDI)/SAP users ( n = 29). AID systems included Medtronic 780 G (38%), Tandem Control-IQ (38%), and CamAPS FX (24%). CGM median wear time was 97.0% (93.3; 98.1). AID users achieved significantly higher TIR (65% vs. 56%, P = 0.041) and time in tight range (TITR) (42% vs 32.5%, P = 0.038). In multivariable regression, AID was the sole independent predictor of lower HbA1c ( P = 0.035). Zero severe hypoglycemia (SH) events occurred in the AID group (vs. 7.1% in MDI/SAP). Use of CGM is safe in very young children, with AID systems proving superior to traditional therapy. This real-world evidence supports incorporating AID consideration into future international guidelines from the time of pediatric diagnosis.