Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod® 5 Automated Insulin Delivery System
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Diabetes technology & therapeutics - (2024) vom: 21. Feb. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
DeSalvo, Daniel J [VerfasserIn] |
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| Links: |
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| Themen: |
Artificial pancreas |
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| Anmerkungen: |
Date Revised 22.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT04476472 Citation Status Publisher |
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| doi: |
10.1089/dia.2023.0506 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367675706 |
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| 100 | 1 | |a DeSalvo, Daniel J |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod® 5 Automated Insulin Delivery System |
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| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Artificial pancreas | |
| 650 | 4 | |a Clinical trials | |
| 650 | 4 | |a Closed-loop systems | |
| 650 | 4 | |a Insulin pumps | |
| 650 | 4 | |a Pediatric diabetes | |
| 650 | 4 | |a Type 1 diabetes | |
| 700 | 1 | |a Bode, Bruce W |e verfasserin |4 aut | |
| 700 | 1 | |a Forlenza, Gregory P |e verfasserin |4 aut | |
| 700 | 1 | |a Laffel, Lori M |e verfasserin |4 aut | |
| 700 | 1 | |a Buckingham, Bruce A |e verfasserin |4 aut | |
| 700 | 1 | |a Criego, Amy B |e verfasserin |4 aut | |
| 700 | 1 | |a Schoelwer, Melissa |e verfasserin |4 aut | |
| 700 | 1 | |a MacLeish, Sarah A |e verfasserin |4 aut | |
| 700 | 1 | |a Sherr, Jennifer L |e verfasserin |4 aut | |
| 700 | 1 | |a Hansen, David W |e verfasserin |4 aut | |
| 700 | 1 | |a Ly, Trang T |e verfasserin |4 aut | |
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