Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes

被引：21

作者：

Criego, Amy B. ^{[1
]}

Carlson, Anders L. ^{[2
]}

Brown, Sue A. ^{[3
]}

Forlenza, Gregory P. ^{[4
]}

Bode, Bruce W. ^{[5
]}

Levy, Carol J. ^{[6
]}

Hansen, David W. ^{[7
]}

Hirsch, Irl B. ^{[8
]}

Bergenstal, Richard M. ^{[2
]}

Sherr, Jennifer L. ^{[9
]}

Mehta, Sanjeev N. ^{[10
]}

Laffel, Lori M. ^{[10
]}

Shah, Viral N. ^{[4
]}

Bhargava, Anuj ^{[11
]}

Weinstock, Ruth S. ^{[12
]}

Macleish, Sarah A. ^{[13
]}

Desalvo, Daniel J. ^{[14
]}

Jones, Thomas C. ^{[15
]}

Aleppo, Grazia ^{[16
]}

Buckingham, Bruce A. ^{[17
]}

Ly, Trang T. ^{[18
,19
]}

机构：

[1] Int Diabet Ctr, Dept Pediat Endocrinol, Pk Nicollet, Minneapolis, MN USA

[2] Int Diabet Ctr, HealthPartners, Pk Nicollet, Minneapolis, MN USA

[3] Univ Virginia, Ctr Diabet Technol, Div Endocrinol, Charlottesville, VA USA

[4] Univ Colorado, Barbara Davis Ctr Diabet, Dept Pediat, Anschutz Med Campus, Aurora, CO USA

[5] Atlanta Diabet Associates, Atlanta, GA USA

[6] Icahn Sch Med Mt Sinai, Div Endocrinol Diabet & Metab, New York, NY USA

[7] SUNY Upstate Med Univ, Dept Pediat, Syracuse, NY USA

[8] Univ Washington, Dept Med, Seattle, WA USA

[9] Yale Sch Med, Dept Pediat, New Haven, CT USA

[10] Joslin Diabet Ctr, Harvard Med Sch, Boston, MA USA

[11] Iowa Diabet Res, W Des Moines, IA USA

[12] SUNY Upstate Med Univ, Dept Med, Syracuse, NY USA

[13] Univ Hosp Cleveland Med Ctr, Rainbow Babies & Childrens Hosp, Dept Pediat, Cleveland, OH USA

[14] Baylor Coll Med, Dept Pediat, Houston, TX USA

[15] Jones Ctr, East Coast Inst Res, Dept Res, Macon, GA USA

[16] Northwestern Univ, Feinberg Sch Med, Div Endocrinol Metab & Mol Med, Chicago, IL USA

[17] Stanford Univ, Dept Pediat, Div Pediat Endocrinol, Stanford, CA USA

[18] Insulet Corp, Acton, MA USA

[19] Insulet Corp, Clin Affairs, 100 Nagog Pk, Acton, MA 01720 USA

来源：

DIABETES TECHNOLOGY & THERAPEUTICS | 2024年 / 26卷 / 01期

关键词：

Type; 1; diabetes; Artificial pancreas; Insulin pumps; Clinical trials; Closed-loop systems;

D O I：

10.1089/dia.2023.0364

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: The Omnipod (R) 5 Automated Insulin Delivery (AID) System was shown to be safe and effective following 3 months of use in people with type 1 diabetes (T1D); however, data on the durability of these results are limited. This study evaluated the long-term safety and effectiveness of Omnipod 5 use in people with T1D during up to 2 years of use.Materials and Methods: After a 3-month single-arm, multicenter, pivotal trial in children (6-13.9 years) and adolescents/adults (14-70 years), participants could continue system use in an extension phase. HbA1c was measured every 3 months for up to 15 months; continuous glucose monitor metrics were collected for up to 2 years.Results: Participants (N = 224) completed median (interquartile range) 22.3 (21.7, 22.7) months of AID. HbA1c was reduced in the pivotal trial from 7.7% +/- 0.9% in children and 7.2% +/- 0.9% in adolescents/adults to 7.0% +/- 0.6% and 6.8% +/- 0.7%, respectively, (P < 0.0001), and was maintained at 7.2% +/- 0.7% and 6.9% +/- 0.6% after 15 months (P < 0.0001 from baseline). Time in target range (70-180 mg/dL) increased from 52.4% +/- 15.6% in children and 63.6% +/- 16.5% in adolescents/adults at baseline to 67.9% +/- 8.0% and 73.8% +/- 10.8%, respectively, during the pivotal trial (P < 0.0001) and was maintained at 65.9% +/- 8.9% and 72.9% +/- 11.3% during the extension (P < 0.0001 from baseline). One episode of diabetic ketoacidosis and seven episodes of severe hypoglycemia occurred during the extension. Children and adolescents/adults spent median 96.1% and 96.3% of time in Automated Mode, respectively.Conclusion: Our study supports that long-term use of the Omnipod 5 AID System can safely maintain improvements in glycemic outcomes for up to 2 years of use in people with T1D.Clinical Trials Registration Number: NCT04196140

引用

页码：11 / 23

页数：13

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