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Symphony transdermal continuous glucose monitoring trial - positiveresults by ferujkll sdff

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Symphony transdermal continuous glucose monitoring trial - positiveresults by
Article Posted: 10/18/2013
Article Views: 287
Articles Written: 2023
Word Count: 597
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Symphony transdermal continuous glucose monitoring trial - positiveresults

Business,Business News,Business Opportunities
Positive results were announced by Echo Therapeutics from itsclinical investigation of its Symphony tCGM System in individualswith type 1 and type 2 diabetes . Echo is developing the system as a wireless, non-invasive,transdermal continuous glucose monitoring (tCGM) system and thePrelude SkinPrep System for transdermal drug delivery. Results from the investigation verified that the systemsuccessfully monitors the wide variety of blood sugar valuesobserved in individuals suffering with diabetes. In addition, Echorevealed its plan to carry out an investigation in individuals incritical care in the near future. Patrick T.

Mooney, M.D., Chairman and CEO of Echo Therapeutics,explained: "This study represents another major step in our Symphonydevelopment program. We have now shown that Symphony represents anovel approach for the tracking and trending of glucose in patientswith diabetes and holds great potential to make a meaningful impactin the management of this growing disease. Importantly, a recent, major U.S, study demonstrated thatreal-time, continuous glucose monitoring gives people with type 2diabetes, in addition to those with type 1 diabetes, improved bloodglucose control. We are extremely pleased with the outcome of the study and lookforward to the continued success of our Symphony tCGM program,including the upcoming trial in critical care patients." Study Design 20 adult patients with type 1 or type 2 diabetes were enrolled toparticipate in the investigation. The researchers analyzed theperformance of the Symphony tCGM System in an outpatient setting ata clinical research organization.

The team prepared each participant's skin using Prelude and thenapplied Symphony tCGM biosensor to the skin site. For 24 hours theteam took venous reference blood samples from intravenous line at15-minute intervals, which were then measured on a YSI 2300 STATPlus Glucose Analyzer. Participants as well as study personnel were blinded toinvestigation data. At the conclusion of the 24-hour investigationperiod, the researchers inspected the test skin sites for rednessor other undesirable effects.

Results from the Investigation When the researchers compared the more than 2,600 Symphony tCGMglucose readings with reference blood glucose measurements, CG-EGArevealed that 2.5% of the readings were benign errors with acombined A+B of 96.9%, while 94.4% of the readings were clinicallyaccurate. The MARD for the investigation was 12.6%. Values forblood sugar measurements varied from 38 to 399 mg/dL. No sideeffects were reported in the study from the Symphony tCGM biosensoror the Prelude skin permeation.

Analytical Methods The researchers compared the Symphony tCGM System with referencemeasurements from a YSI 2300 STAT Plus Glucose Analyzer. The teamthen paired those reference measurements with the Symphony resultsvia a data analysis algorithm. The Continuous Glucose-Error Grid analysis (CG-EGA) and MeanAbsolute Relative Difference (MARD) were the primary statisticalanalysis tools the team used in order to analyze the performance ofSymphony. The CG-EGA is a categorization of all data pairs based onthe clinical significance of the accuracy.

Accurate readings resultin the same clinical decision when based on the CGM value versusthe blood sugar value. Although the actual clinical decision might differ, benign errorsresult in the same clinical outcome as accurate readings. Theperformance of CGM is measured as the sum of benign errors andaccurate readings. The researchers used MARD, an error calculationtool used to measure the absolute value of the average relativedifference between Symphony and the reference measurements, inorder to measure Numerical accuracy on a percentage basis. Written by Grace Rattue Copyright: Medical News Today Not to be reproduced without permission of Medical News Today Additional References Citations.

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