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.

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Publication Details

Journal
Diabetes Technology & Therapeutics
Published
2026-08-18
DOI
https://doi.org/10.1177/15209156261479814
Primary Topic
Diabetes Management and Research
Type
article
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article

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

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Diabetes Technology & Therapeutics
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article

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

Andrea Scaramuzza, Davide Tinti, Valentino Cherubini, Claudia Arnaldi, Giulio Maltoni, Valentina Tiberi, Fortunato Lombardo, Riccardo Bonfanti, Enza Mozzillo, Marco Marigliano, Riccardo Schiaffini, Claudio Maffeis, Roberto Franceschi, Marta Bassi, Ivana Rabbone
article en

Abstract

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.

Diabetes Technology & Therapeutics
University of Messina (IT), University of Verona (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), Vita-Salute San Raffaele University (IT), University of Trento (IT), Diabetes Australia (AU), Istituto Giannina Gaslini (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Azienda Ospedaliera Universitaria Integrata Verona (IT), Azienda Sanitaria Locale Viterbo (IT), Azienda USL di Bologna (IT), Bambino Gesù Children's Hospital (IT), Azienda Ospedaliera Ospedale Maggiore (IT), Ospedali Riuniti Umberto I (IT), Istituti Ospitalieri di Cremona (IT), University of Naples Federico II (IT), University of Genoa (IT)
Partnerships for the goals
Openalex Percentile: Top 10%
Diabetes Management and Research
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