Clinical Experience of an Iontophoresis Based Glucose Measuring System

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Clinical Experience of an Iontophoresis Based Glucose Measuring System Sang Youl Rhee*,., Suk Chon*,.,Gwanpyo Koh*,., Jeong Ryung Paeng.,Seungjoon Oh*,., Jeong-taek Woo*,., Sung Woon Kim*,., Jin-Woo Kim*,.,Young Seol Kim*,. Departments of Endocrinology and Metabolism*, Research Institute of Endocrinology., College of Medicine, Kyung Hee University, Seoul, Korea J Korean Med Sci 2007; 22: 70-3 ISSN 1011-8934 Prof. Sang Youl Rhee R1 Jun Wook Lim

INTRODUCTION - The need of appearance of RIGMD FINGER PRICKING METHOD - Apprehension, Pain, Low compliance LIMITED INFORMATION OF GLUCOSE LEVEL CHANGES - Frequency of glucose level checking is 4 times a day CGMS (CONTINUOUS GLUCOSE MONITORING SYSTEM) - Not easily operated by a patient TM

INTRODUCTION – The principle of Gluco-watch and RIGMD TM GLUCO-WATCH - It is the first commercially useful device - Non invasive continuous method of measuring glucose concentration in interstitial fluid by reverse iontophoresis RIGMD (Reverse Iontophoresis based Glucose Monitoring Device) - Measures interstitial fluid glucose concentrations via an electrochemical enzymatic sensor every 5min. TM

AIM OF THIS STUDY To investigate the accuracy and clinical acceptability of this new device by comparing the data obtained from it and plasma glucose levels obtained by venous sampling.

REVERSE IONTOPHORESIS MATERIALS AND METHODS OPERATIONG PRINCIPLE OF RIGMD - Experiments conducted in vivo in 1995 Sensor Glucose oxidase Glucose+O2 Glucuronic acid+ H2O2 2e- + O2+ 2H Glucose concentration Skin Electrode Electrode Microcurrent REVERSE IONTOPHORESIS Glucose

MATERIALS AND METHODS STUDY SUBJECTS DATA ANALYSIS - 28 type 1 and type 2 diabetes mellitus patients admitted to the Kyung Hee University Hospital - November 2003 - January 2004. - Nine of the 28 candidates were excluded The exclusion criteria 1) continuous hypo- or hyperglycemia (<40 mg/dL or >450 mg/dL); 2) electronic auxiliaries fitted such as cardiac pace maker; 3) an abruption or injury to forearm skin; 4) acetaminophen administration within 72 hr of the initiation of the data collection; . 5) mentally illness; 6) peripheral vascular disease; or 7) anemia. Acetaminophen is known to potentially interfere with conventional glucose monitoring devices STUDY PROTOCOL 1) RIGMD vs venous blood sampling 2) Checked hourly in each patient 3) From 10 a.m. to 4 p.m. DATA ANALYSIS 1) SPSS Version 11.0 2) The Clarke error grid analysis 3) linear regression analysis

RESULTS - 1

RESULTS - 2

RESULTS - 3

RESULTS - 4

RESULTS - 5

DISCUSSION CORRELATION COEFFICIENT Gluco Watch biographer studies > RIGMD (r=0.784) Fewer subjects lower reliability Gluco Watch using the finger prick method Effection location, skin thickeness, temperature, perspiration Not sufficiently reliable, not accurate enough to replace conventional methods of monitoring glucose