Article Document Academic Article Information Content Entity Journal Article Continuant Continuant Entity Entity Generically Dependent Continuant 2025-05-08T04:51:44 RDF description of Safety and glycemic outcomes with a tubeless automated insulin delivery system in very young children with type 1 diabetes: a single-arm multicenter clinical trial - http://repository.healthpartners.com/individual/document-rn30281 Safety and glycemic outcomes with a tubeless automated insulin delivery system in very young children with type 1 diabetes: a single-arm multicenter clinical trial public Pediatrics document-rn30281 Drugs and Drug Therapy 10.2337/dc21-2359 2022-02-21T22:48:57.408-06:00 8 Clinical Trials 34234 45 Blood Diabetes 20037 <p>OBJECTIVE: Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population. RESEARCH DESIGN AND METHODS: A total of 80 children aged 2.0-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy. RESULTS: There were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70-180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204). CONCLUSIONS: Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.<p> Diabetes care