1000-P: Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real-World Study (BURST)—A Twelve-Month Analysis

IF 6.2 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Pub Date : 2025-06-13 DOI:10.2337/db25-1000-p

JOHN TILLMAN, ROY W. BECK, WILLIAM H. POLONSKY, PETER CALHOUN, THOMAS J. MOUSE, RYAN BAILEY, RAKESH NANDAN

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引用次数: 0

Abstract

Introduction and Objective: The Bigfoot Unity System integrates Abbott FreeStyle Libre 2 CGM data into a smart insulin pen cap and mobile app enabling clinician-directed insulin dose recommendations and real time alerts. The objective was to analyze real world, 12-month data for System users. Methods: We conducted a 12-month final analysis from the prospective BURST study (NCT05088265) and report the per-protocol results (N=125). Participants completed baseline, adverse event and patient-reported outcome surveys electronically. HbA1c data were from home kits or electronic medical records. Results: Median age was 58 years and 86% had T2D. Mean HbA1c decreased from 9.2±1.8% at baseline to 8.0±1.2% at 12 months (mean change -1.3%, 95%CI -1.6, -0.9; p<0.001). There were six severe hypoglycemia events in 4 participants (none System related), and no DKA. Diabetes Distress Scale scores decreased (mean change -0.8, 95%CI -1.0, -0.6; p<0.001) and Hypoglycemic Confidence Scale scores increased (mean change 0.5, 95%CI 0.4, 0.7; p<0.001) with System use (Table). Conclusion: Durable glycemic improvement with reduced diabetes distress and increased hypoglycemic confidence occurred using the System for 6 months and sustained through 12 months. The reduction in HbA1c occurred while meeting established hypoglycemia targets of <4 and <1% for percent time below 70 and 54 mg/dL, respectively. Disclosure J. Tillman: Employee; Abbott. R.W. Beck: Research Support; Insulet Corporation. Consultant; Insulet Corporation. Research Support; Tandem Diabetes Care, Inc, Beta Bionics, Inc, Dexcom, Inc., Bigfoot Biomedical, Inc, Abbott, embecta, Sequel Med Tech, MannKind Corporation. Consultant; Novo Nordisk, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Zucara Therapeutics, Abata Therapeutics, Eli Lilly and Company. W.H. Polonsky: Consultant; Abbott. Research Support; Abbott. Consultant; Dexcom, Inc. Research Support; Dexcom, Inc. Other Relationship; Ascensia Diabetes Care. P. Calhoun: None. T.J. Mouse: None. R. Bailey: None. R. Nandan: Employee; Abbott, Bigfoot Biomedical, Inc. Funding Abbott

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1000-P：在前瞻性大脚统一真实世界研究（BURST）中观察到的血糖和心理社会益处- 12个月的分析

介绍和目的：大脚统一系统将雅培FreeStyle Libre 2 CGM数据集成到智能胰岛素笔帽和移动应用程序中，实现临床指导的胰岛素剂量推荐和实时警报。目的是为系统用户分析真实世界的12个月数据。方法：我们对前瞻性BURST研究（NCT05088265）进行了为期12个月的最终分析，并报告了每个方案的结果（N=125）。参与者以电子方式完成基线、不良事件和患者报告结果调查。HbA1c数据来自家庭试剂盒或电子病历。结果：中位年龄58岁，T2D患者占86%。平均HbA1c从基线时的9.2±1.8%下降到12个月时的8.0±1.2%(平均变化-1.3%,95%CI -1.6, -0.9；p&肝移植;0.001)。4名受试者发生6次严重低血糖事件（无系统相关），无DKA。糖尿病困扰量表得分下降(平均变化-0.8,95%CI -1.0, -0.6；p<0.001)，低血糖置信度评分增加(平均变化0.5,95%CI 0.4, 0.7；p<0.001)与系统使用（表）。结论：使用该系统6个月并持续12个月，血糖持续改善，糖尿病窘迫减少，低血糖自信增加。当HbA1c分别在低于70 mg/dL和54 mg/dL的1%时间内达到既定的低血糖目标时，发生了降低。J.蒂尔曼：雇员；阿伯特。R.W. Beck：研究支持；Insulet公司。顾问;Insulet公司。研究支持;Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Abbott, embecta, Sequel Med Tech, MannKind Corporation。顾问;Novo Nordisk, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Zucara Therapeutics, Abata Therapeutics, Eli Lilly and Company。W.H.波隆斯基：顾问；阿伯特。研究支持;阿伯特。顾问;, Dexcom公司将公司。研究支持;, Dexcom公司将公司。其他关系;Ascensia Diabetes Care。P.卡尔霍恩：没有。老鼠：没有。R.贝利：没有。R. Nandan：雇员；Abbott, Bigfoot Biomedical, Inc。资金雅培

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来源期刊

Diabetes 医学-内分泌学与代谢

CiteScore

12.50

自引率

2.60%

发文量

1968

审稿时长

1 months

期刊介绍： Diabetes is a scientific journal that publishes original research exploring the physiological and pathophysiological aspects of diabetes mellitus. We encourage submissions of manuscripts pertaining to laboratory, animal, or human research, covering a wide range of topics. Our primary focus is on investigative reports investigating various aspects such as the development and progression of diabetes, along with its associated complications. We also welcome studies delving into normal and pathological pancreatic islet function and intermediary metabolism, as well as exploring the mechanisms of drug and hormone action from a pharmacological perspective. Additionally, we encourage submissions that delve into the biochemical and molecular aspects of both normal and abnormal biological processes. However, it is important to note that we do not publish studies relating to diabetes education or the application of accepted therapeutic and diagnostic approaches to patients with diabetes mellitus. Our aim is to provide a platform for research that contributes to advancing our understanding of the underlying mechanisms and processes of diabetes.