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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引用次数: 0
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.
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.