Ananda Basu1, Sona Veettil1, Roy Dyer2, Thomas Peyser3, Rita Basu1. 1. 1 Endocrine Research Unit, Saint Mary's Hospital , Mayo Clinic, Rochester, Minnesota. 2. 2 Immunochemical Core Laboratory, Mayo Clinic , Rochester, Minnesota. 3. 3 Automated Glucose Control LLC , Palo Alto, California.
Abstract
BACKGROUND: Recent advances in accuracy and reliability of continuous glucose monitoring (CGM) devices have focused renewed interest on the use of such technology for therapeutic dosing of insulin without the need for independent confirmatory blood glucose meter measurements. An important issue that remains is the susceptibility of CGM devices to erroneous readings in the presence of common pharmacologic interferences. We report on a new method of assessing CGM sensor error to pharmacologic interferences using the example of oral administration of acetaminophen. MATERIALS AND METHODS: We examined the responses of several different Food and Drug Administration-approved and commercially available CGM systems (Dexcom [San Diego, CA] Seven(®) Plus™, Medtronic Diabetes [Northridge, CA] Guardian(®), and Dexcom G4(®) Platinum) to oral acetaminophen in 10 healthy volunteers without diabetes. Microdialysis catheters were placed in the abdominal subcutaneous tissue. Blood and microdialysate samples were collected periodically and analyzed for glucose and acetaminophen concentrations before and after oral ingestion of 1 g of acetaminophen. We compared the response of CGM sensors with the measured acetaminophen concentrations in the blood and interstitial fluid. RESULTS: Although plasma glucose concentrations remained constant at approximately 90 mg/dL (approximately 5 mM) throughout the study, CGM glucose measurements varied between approximately 85 to 400 mg/dL (from approximately 5 to 22 mM) due to interference from the acetaminophen. The temporal profile of CGM interference followed acetaminophen concentrations measured in interstitial fluid (ISF). CONCLUSIONS: This is the first direct measurement of ISF concentrations of putative CGM interferences with simultaneous measurements of CGM performance in the presence of the interferences. The observed interference with glucose measurements in the tested CGM devices coincided temporally with appearance of acetaminophen in the ISF. The method applied here can be used to determine the susceptibility of current and future CGM systems to interference from acetaminophen or other exogenous pharmacologic agents.
BACKGROUND: Recent advances in accuracy and reliability of continuous glucose monitoring (CGM) devices have focused renewed interest on the use of such technology for therapeutic dosing of insulin without the need for independent confirmatory blood glucose meter measurements. An important issue that remains is the susceptibility of CGM devices to erroneous readings in the presence of common pharmacologic interferences. We report on a new method of assessing CGM sensor error to pharmacologic interferences using the example of oral administration of acetaminophen. MATERIALS AND METHODS: We examined the responses of several different Food and Drug Administration-approved and commercially available CGM systems (Dexcom [San Diego, CA] Seven(®) Plus™, Medtronic Diabetes [Northridge, CA] Guardian(®), and Dexcom G4(®) Platinum) to oral acetaminophen in 10 healthy volunteers without diabetes. Microdialysis catheters were placed in the abdominal subcutaneous tissue. Blood and microdialysate samples were collected periodically and analyzed for glucose and acetaminophen concentrations before and after oral ingestion of 1 g of acetaminophen. We compared the response of CGM sensors with the measured acetaminophen concentrations in the blood and interstitial fluid. RESULTS: Although plasma glucose concentrations remained constant at approximately 90 mg/dL (approximately 5 mM) throughout the study, CGM glucose measurements varied between approximately 85 to 400 mg/dL (from approximately 5 to 22 mM) due to interference from the acetaminophen. The temporal profile of CGM interference followed acetaminophen concentrations measured in interstitial fluid (ISF). CONCLUSIONS: This is the first direct measurement of ISF concentrations of putative CGM interferences with simultaneous measurements of CGM performance in the presence of the interferences. The observed interference with glucose measurements in the tested CGM devices coincided temporally with appearance of acetaminophen in the ISF. The method applied here can be used to determine the susceptibility of current and future CGM systems to interference from acetaminophen or other exogenous pharmacologic agents.
Authors: Timothy S Bailey; Andrew Ahmann; Ronald Brazg; Mark Christiansen; Satish Garg; Elaine Watkins; John B Welsh; Scott W Lee Journal: Diabetes Technol Ther Date: 2014-04-07 Impact factor: 6.118
Authors: Firas H El-Khatib; Courtney Balliro; Mallory A Hillard; Kendra L Magyar; Laya Ekhlaspour; Manasi Sinha; Debbie Mondesir; Aryan Esmaeili; Celia Hartigan; Michael J Thompson; Samir Malkani; J Paul Lock; David M Harlan; Paula Clinton; Eliana Frank; Darrell M Wilson; Daniel DeSalvo; Lisa Norlander; Trang Ly; Bruce A Buckingham; Jamie Diner; Milana Dezube; Laura A Young; April Goley; M Sue Kirkman; John B Buse; Hui Zheng; Rajendranath R Selagamsetty; Edward R Damiano; Steven J Russell Journal: Lancet Date: 2016-12-20 Impact factor: 79.321