دورية أكاديمية
Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod ® 5 Automated Insulin Delivery System.
| العنوان: | Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod ® 5 Automated Insulin Delivery System. |
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| المؤلفون: | DeSalvo DJ; Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA., Bode BW; Atlanta Diabetes Associates, Atlanta, Georgia, USA., Forlenza GP; Department of Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA., Laffel LM; Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA., Buckingham BA; Division of Pediatric Endocrinology, Department of Pediatrics, Stanford University, Stanford, California, USA., Criego AB; International Diabetes Center-HealthPartners Institute, Park Nicollet Pediatric Endocrinology, Minneapolis, Minnesota, USA., Schoelwer M; Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA., MacLeish SA; Department of Pediatrics, University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA., Sherr JL; Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut, USA., Hansen DW; Department of Pediatrics, SUNY Upstate Medical University, Syracuse, New York, USA., Ly TT; Clinical Affairs Department, Insulet Corporation, Acton, Massachusetts, USA. |
| المصدر: | Diabetes technology & therapeutics [Diabetes Technol Ther] 2024 Jun; Vol. 26 (6), pp. 383-393. Date of Electronic Publication: 2024 Feb 21. |
| نوع المنشور: | Journal Article; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Mary Ann Liebert, Inc Country of Publication: United States NLM ID: 100889084 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-8593 (Electronic) Linking ISSN: 15209156 NLM ISO Abbreviation: Diabetes Technol Ther Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Larchmont, NY : Mary Ann Liebert, Inc., c1999- |
| مواضيع طبية MeSH: | Diabetes Mellitus, Type 1*/drug therapy , Diabetes Mellitus, Type 1*/blood , Insulin Infusion Systems* , Insulin*/administration & dosage , Insulin*/therapeutic use , Blood Glucose*/analysis , Hypoglycemic Agents*/administration & dosage , Hypoglycemic Agents*/therapeutic use , Glycated Hemoglobin*/analysis, Humans ; Child, Preschool ; Female ; Male ; Hypoglycemia/prevention & control ; Treatment Outcome ; Glycemic Control/methods ; Blood Glucose Self-Monitoring |
| مستخلص: | Background: To evaluate the long-term safety and effectiveness of the Omnipod ® 5 Automated Insulin Delivery (AID) System in very young children with type 1 diabetes with up to 2 years of use. Methods: Following a 13-week single-arm, multicenter, pivotal trial that took place after 14 days of standard therapy data collection, participating children (2-5.9 years of age at study enrollment) were provided the option to continue use of the AID system in an extension phase. HbA1c was measured every 3 months, up to 15 months of total use, and continuous glucose monitor metrics were collected through the completion of the extension study (for up to 2 years). Results: Participants ( N = 80) completed 18.2 [17.4, 23.4] (median [interquartile range]) total months of AID, inclusive of the 3-month pivotal trial. During the pivotal trial, HbA1c decreased from 7.4% ± 1.0% (57 ± 10.9 mmol/mol) to 6.9% ± 0.7% (52 ± 7.7 mmol/mol, P < 0.0001) and was maintained at 7.0% ± 0.7% (53 ± 7.7 mmol/mol) after 15 months total use ( P < 0.0001 from baseline). Time in target range (70-180 mg/dL) increased from 57.2% ± 15.3% during standard therapy to 68.1% ± 9.0% during the pivotal trial ( P < 0.0001) and was maintained at 67.2% ± 9.3% during the extension phase ( P < 0.0001 from standard therapy). Participants spent a median 97.1% of time in Automated Mode during the extension phase, with one episode of severe hypoglycemia and one episode of diabetic ketoacidosis. Conclusion: This evaluation of the Omnipod 5 AID System indicates that long-term use can safely maintain improvements in glycemic outcomes with up to 2 years of use in very young children with type 1 diabetes. Clinical Trials Registration Number: NCT04476472. |
| فهرسة مساهمة: | Keywords: Artificial pancreas; Clinical trials; Closed-loop systems; Insulin pumps; Pediatric diabetes; Type 1 diabetes |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04476472 |
| المشرفين على المادة: | 0 (Insulin) 0 (Blood Glucose) 0 (Hypoglycemic Agents) 0 (Glycated Hemoglobin) 0 (hemoglobin A1c protein, human) |
| تواريخ الأحداث: | Date Created: 20240126 Date Completed: 20240603 Latest Revision: 20240717 |
| رمز التحديث: | 20240717 |
| DOI: | 10.1089/dia.2023.0506 |
| PMID: | 38277156 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1557-8593 |
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| DOI: | 10.1089/dia.2023.0506 |