1928-LB: Feasibility of Calibration-Free Intradermal Glucose Monitoring Using a Sensor Microarray

IF 6.2 1区医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes Pub Date : 2024-07-19 DOI:10.2337/db24-1928-lb

MARK P. CHRISTIANSEN, NARESH C. BHAVARAJU, REBECCA GOTTLIEB, ALAN CAMPBELL, SIRILAK SATTAYASAMITSATHIT, MARK C. BRISTER, KEITH NOGUEIRA, AMY L. VANDENBERG, RICH YANG, JARED R. TANGNEY

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Abstract

Introduction: Subcutaneous glucose sensors using introducer needles have been well characterized. Robust microsensors are required for a less invasive approach, accessing interstitial glucose in the dermis. Advancements in semiconductor manufacturing have facilitated new sensing technologies using arrays of silicon microsensors on a wearable patch without introducer needles. Several independent electrodes on the microarray chip support redundancy and reliability. The objective of this study was to evaluate the performance of a calibration-free, intradermal glucose sensor, compared to a gold standard. Methods: A 5-day study was conducted at two US sites evaluating the device in persons with Diabetes. Intradermal glucose sensors were placed on the volar forearm or upper arm. All subjects participated in one clinic day on Day 1, 3, or 5 of wear. Venous blood was obtained every 15 minutes for 8 hours and analyzed with the YSI (YSI Inc, Yellow Springs, Ohio) 2300 Stat Plus. A prospective, calibration-free algorithm was used. Results: 19 subjects with Type 1 diabetes ages 19 to 70 were studied. Mean Absolute Relative Difference (MARD) was 10.1% compared to YSI (n=388). 83.2% of paired points were within 20% of YSI and 100% were within Clark Error Grid A+B regions. Conclusion: The intradermal glucose sensor demonstrated accurate tracking and trending of glucose levels compared to the gold standard laboratory analyzer. Disclosure M.P. Christiansen: Research Support; Abbott Diagnostics, Amgen Inc., Biolinq, Boehringer-Ingelheim, Dexcom, Inc., Eli Lilly and Company, Google, Lilly Diabetes, MannKind Corporation, Medtronic, Novo Nordisk, Pfizer Inc., Roche Diabetes Care, REMD Biotherapeutics, ViaCyte, Inc. N.C. Bhavaraju: Employee; Biolinq. R. Gottlieb: Employee; Biolinq. A. Campbell: Employee; Biolinq. S. Sattayasamitsathit: Employee; Biolinq. M.C. Brister: Employee; Biolinq. K. Nogueira: Employee; Biolinq. A.L. VandenBerg: Employee; Biolinq. J.R. Tangney: Employee; Biolinq.

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1928-LB：使用传感器微阵列进行免校准皮内葡萄糖监测的可行性

简介：使用导入针的皮下葡萄糖传感器已具有良好的特性。要采用侵入性较小的方法，获取真皮层间隙葡萄糖，就需要坚固耐用的微型传感器。半导体制造技术的进步促进了新的传感技术的发展，在可穿戴贴片上使用硅微型传感器阵列，无需导入针。微阵列芯片上的多个独立电极支持冗余和可靠性。本研究的目的是评估免校准皮内葡萄糖传感器与金标准相比的性能。研究方法在美国的两个地点进行了为期 5 天的研究，对糖尿病患者的设备进行评估。皮内葡萄糖传感器被放置在前臂或上臂。所有受试者都在佩戴后的第 1、3 或 5 天参加了一天的门诊。每 15 分钟采集一次静脉血，连续采集 8 小时，然后用 YSI（YSI Inc，俄亥俄州黄泉市）2300 Stat Plus 进行分析。采用的是一种前瞻性的免校准算法。结果：研究对象为 19 至 70 岁的 1 型糖尿病患者。与 YSI（n=388）相比，平均绝对相对差值（MARD）为 10.1%。83.2%的配对点在 YSI 的 20% 范围内，100% 在克拉克误差网格 A+B 区域内。结论与金标准实验室分析仪相比，皮内葡萄糖传感器能准确跟踪血糖水平并显示其变化趋势。披露 M.P. Christiansen：研究支持；雅培诊断公司、安进公司、Biolinq、勃林格殷格翰公司、Dexcom 公司、礼来公司、谷歌公司、礼来糖尿病公司、MannKind 公司、美敦力公司、诺和诺德公司、辉瑞公司、罗氏糖尿病护理公司、REMD 生物治疗公司、ViaCyte 公司、N.C. Bhavarajad, Inc.N.C. Bhavaraju：雇员；Biolinq.R. Gottlieb：员工；Biolinq.A. Campbell：员工；Biolinq.S. Sattayasamitsathit：S. Sattayasamitsathit: Employee; Biolinq.M.C. Brister：雇员；Biolinq.K. Nogueira: Employee; Biolinq.A.L. VandenBerg：雇员；Biolinq.J.R. Tangney：员工；Biolinq.

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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.