Aleppo Grazia, DeSalvo Daniel J, Lauand Felipe, Huyett Lauren M, Chang Albert, Vienneau Todd, Ly Trang T
Division of Endocrinology, Metabolism and Molecular Medicine, Feinberg School of Medicine, Northwestern University, 645 North Michigan Ave, Suite 530, Chicago, IL, 60611, USA.
Baylor College of Medicine, 1 Moursund St., Houston, TX, 77030, USA.
Diabetes Ther. 2023 Mar;14(3):593-610. doi: 10.1007/s13300-023-01366-9. Epub 2023 Feb 10.
Despite recent advances in diabetes technology, most people living with type 1 diabetes mellitus (T1D) are unable to meet glycemic targets. Real-world evidence can provide insight into outcomes achieved with specific treatment devices when used in clinical practice. The aim of this study was to analyze real-world outcomes collected from a large cohort of people living with T1D and initiating treatment with the Omnipod DASH System.
In this retrospective observational study, real-world outcomes were analyzed from a database of information collected from people with T1D initiating the Omnipod DASH System. Information in the database was either taken directly from the patient's medical record or self-reported if medical records were unavailable. The primary outcome was change in glycated hemoglobin (HbA1c) from baseline (before initiation) to 3 months after initiation. Secondary outcomes were changes in total daily dose of insulin (TDD) and self-reported frequency of hypoglycemic events (< 70 mg/dL). Results are separated for the adult (≥ 18 years, N = 3341) and pediatric (< 18 years, N = 1397) cohorts.
The change in HbA1c from baseline was - 0.9 ± 1.6% ( - 10 ± 18 mmol/mol; p < 0.0001) in adults and - 0.9 ± 2.0% ( - 10 ± 22 mmol/mol; p < 0.0001) in the pediatric cohort. For those previously using multiple daily injections, HbA1c decreased by - 1.0 ± 1.7% ( - 11 ± 19 mmol/mol) in adults and - 1.0 ± 2.1% ( - 11 ± 23 mmol/mol) in the pediatric cohort (both p < 0.0001). Hypoglycemic events decreased in adults from 2.9 to 1.3 episodes per week ( - 1.6 ± 3.2 events/week; p < 0.0001), and in the pediatric cohort from 2.8 to 1.5 episodes per week ( - 1.3 ± 2.7 events/week; p < 0.0001). In adults, TDD decreased by 19.9% (p < 0.0001), and it remained stable in the pediatric cohort (p > 0.05).
Real-world outcomes from this large cohort of people initiating therapy with the Omnipod DASH System showed significant improvement in HbA1c and a substantial reduction in hypoglycemic events after 3 months of use.
尽管糖尿病技术最近取得了进展，但大多数1型糖尿病（T1D）患者仍无法达到血糖目标。真实世界证据可以深入了解特定治疗设备在临床实践中使用时所取得的结果。本研究的目的是分析从一大群T1D患者队列中收集的真实世界结果，这些患者开始使用Omnipod DASH系统进行治疗。
在这项回顾性观察研究中，对从开始使用Omnipod DASH系统的T1D患者收集的信息数据库中的真实世界结果进行了分析。数据库中的信息要么直接取自患者的病历，要么在无法获取病历时由患者自我报告。主要结局是糖化血红蛋白（HbA1c）从基线（开始治疗前）到开始治疗后3个月的变化。次要结局是胰岛素每日总剂量（TDD）的变化和自我报告的低血糖事件发生频率（<70mg/dL）。结果按成人（≥18岁，N = 3341）和儿科（<18岁，N = 1397）队列进行分类。
成人HbA1c从基线的变化为-0.9±1.6%（-10±18mmol/mol；p<0.0001），儿科队列中为-0.9±2.0%（-10±22mmol/mol；p<0.0001）。对于之前使用多次每日注射的患者，成人HbA1c下降了-1.0±1.7%（-11±19mmol/mol），儿科队列中下降了-1.0±2.1%（-11±23mmol/mol）（两者p<0.0001）。成人低血糖事件从每周2.9次降至1.3次（-1.6±3.2次/周；p<0.0001），儿科队列中从每周2.8次降至1.5次（-1.3±2.7次/周；p<0.0001）。在成人中，TDD下降了19.9%（p<0.0001），而在儿科队列中保持稳定（p>0.05）。
这一大群开始使用Omnipod DASH系统治疗的患者的真实世界结果显示，使用3个月后HbA1c有显著改善，低血糖事件大幅减少。
