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Continuous Glucose Monitoring Roadmap for 21St Century Diabetes Therapy

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Continuous Glucose Monitoring Roadmap for 21St Century Diabetes Therapy Reviews/Commentaries/ADA Statements REVIEW ARTICLE Continuous Glucose Monitoring Roadmap for 21st century diabetes therapy DAVID C. KLONOFF, MD, FACP toring System Gold (CGMS Gold; Medtronic MiniMed, Northridge, CA) (1), the GlucoWatch G2 Biographer (GW2B; Cygnus, Redwood City, CA) (2), ontinuous glucose monitoring pro- era, on the other hand, takes multiple, the Guardian Telemetered Glucose Mon- vides maximal information about poorly focused frames; displays a sequen- itoring System (Medtronic MiniMed) (3), C shifting blood glucose levels tial array of frames whose trend predicts the GlucoDay (A. Menarini Diagnostics, throughout the day and facilitates the the future; produces too much informa- Florence, Italy) (4), and the Pendra (Pen- making of optimal treatment decisions for tion for each frame to be studied carefully; dragon Medical, Zurich, Switzerland) (5). the diabetic patient. This report discusses and operates automatically after it is A sixth monitor, whose premarket ap- continuous glucose monitoring in terms turned on. The two types of blood glucose proval application has been submitted to of its purposes, technologies, target pop- monitors differ in much the same way: 1) the FDA, is the FreeStyle Navigator Con- ulations, accuracy, clinical indications, an intermittent blood glucose monitor tinuous Glucose Monitor (Abbott Labora- outcomes, and problems. In this context, measures discrete glucose levels ex- tories, Alameda, CA) (6). the medical literature on continuous glu- tremely accurately, whereas a continuous The currently available CGMs mea- cose monitoring available through the monitor provides multiple glucose levels sure blood glucose either with minimal end of 2004 is reviewed. of fair accuracy; 2) with an intermittent invasiveness through continuous mea- monitor, current blood glucose levels do surement of interstitial fluid (ISF) or with PURPOSES — Continuous glucose not predict future glucose levels, but with the noninvasive method of applying elec- monitoring provides information about a continuous monitor, trends in glucose tromagnetic radiation through the skin to the direction, magnitude, duration, fre- levels do have this predictive capability; blood vessels in the body. The technolo- quency, and causes of fluctuations in 3) with an intermittent monitor, it is easy gies for bringing a sensor into contact blood glucose levels. Compared with con- to study every measured blood glucose with ISF include inserting an indwelling ventional intensified glucose monitoring, value over most time periods, but with a sensor subcutaneously (into the abdomi- defined as three to four blood glucose continuous monitor, too many data are nal wall or arm) to measure ISF in situ or measurements per day, continuous mon- generated to study all data points; and 4) harvesting this fluid by various mecha- itoring provides much greater insight into an intermittent blood glucose monitor re- nisms that compromise the skin barrier glucose levels throughout the day. Con- quires effort to operate, whereas a contin- and delivering the fluid to an external sen- tinuous glucose readings that supply uous monitor does not. Returning to the sor (7). These ISF measurement technol- trend information can help identify and camera analogy, just as the best tool for ogies are defined as minimally invasive prevent unwanted periods of hypo- and closely monitoring a situation when the because they compromise the skin barrier hyperglycemia. outcome is important often may be a con- but do not puncture any blood vessels. The difference between an intermit- tinuous security camera rather than a reg- After a warm-up period of up to 2 h and a tent and a continuous monitor for moni- ular camera, likewise the best way to device-specific calibration process, each toring blood glucose is similar to that monitor diabetes often may be a continu- device’s sensor will provide a blood glu- between a regular camera and a continu- ous glucose monitor (CGM) rather than cose reading every 1–10 min for up to ous security camera for monitoring an im- an intermittent monitor. 72 h with the minimally invasive technol- portant situation. A regular camera takes ogy and up to 3 months with the nonin- discrete, accurate snapshots; its pictures TECHNOLOGIES — Five CGMs have vasive technology. Results are available to do not predict the future; it produces a been approved by the U.S. Food and Drug the patient in real time or retrospectively. small set of pictures that can all be care- Administration (FDA) for use in the U.S. Every manufacturer of a CGM produces at fully studied; and effort is required to take or carry CE marking for use in Europe. least one model that sounds an alarm if each picture. A continuous security cam- They are the Continuous Glucose Moni- the glucose level falls outside of a preset ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● euglycemic range. The available and From the Mills-Peninsula Health Services Diabetes Research Institute, San Mateo, California. likely soon-to-be-available CGMs are Address correspondence and reprint requests to David C. Klonoff, MD, Mills-Peninsula Health Services compared in Table 1. Diabetes Research Institute, 100 S. San Mateo Dr., Rm. 3124, San Mateo, CA 94401. E-mail: klonoff@itsa. ucsf.edu. Based on their mechanisms, specifica- Received for publication 15 December 2004 and accepted in revised form 31 January 2005. tions, and performance records, each Abbreviations: CGM, continuous glucose monitor; CGMS, continuous glucose monitoring system; EGA, CGM offers a particular set of features that error grid analysis; FDA, U.S. Food and Drug Administration; GW2B, GlucoWatch G2 Biographer; ISF, are attractive for patients and clinicians. interstitial fluid; ISO, International Organization for Standardization; RAD, relative absolute difference. A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion Table 2 presents three of these features for factors for many substances. each available and likely soon-to-be- © 2005 by the American Diabetes Association. available CGM. DIABETES CARE, VOLUME 28, NUMBER 5, MAY 2005 1231 Continuous glucose monitoring Invasive indwelling intravascular sen- Yes sors that measure blood glucose directly are also under development for monitor- ing hospitalized patients. Prolonged use of such devices might cause vascular display Alarm damage or infection. No articles have retrospective glucose data Time of blood been published on their performance. TARGET POPULATIONS —Proper testing (min) patient selection will ensure safe use of Frequency of CGMs. Patients should be motivated to participate in their diabetes care, in- formed about diabetes, and mechanically Sensor lifespan (h) adept. These characteristics are even more necessary for real-time than for retrospec- tive monitors. Currently available CGMs require up to four finger-stick (not alter- of sensor per lifetime Calibrations nate site) blood glucose measurements per day for calibration. The ideal time to 2 1 13 10 Real time Yes (h) calibrate is either after fasting or at least Sensor warmup 3 h postprandially, but not right after ex- ercise or when the blood glucose level is likely to be rising or falling. Without such calibration, continuous readings may be inaccurate. Currently available CGMs that provide real-time readings should not be used to make therapeutic deci- forearm External on wrist 1 20 3 monthssions, 1 Real timesuch as Yes whether to dose insulin or eat, because they are not sufficiently ac- curate. Instead, an abnormal reading should prompt a finger-stick blood glu- cose measurement whose value can be acted upon. Patients require a thorough training program to calibrate and operate spectroscopy a CGM. Furthermore, patients using real- time CGMs require extensive diabetes ed- ucation to make safe and effective therapeutic decisions. In particular, they must know the duration of their boluses of insulin to avoid repeatedly and exces- sively injecting themselves with unneces- sary extra doses of insulin over a short duration for hyperglycemia that does not immediately respond to the first insulin Year first approved or marked Sensor type Sensor mechanism Sensor location dose. The second-generation CGMS Gold CE and its first-generation predecessor, marked CGMS, together have been studied in the greatest number of articles about contin- uous glucose monitoring in the medical Yes YesYes 1999 Yes Minimally invasive Enzyme-tipped catheter Subcutaneous 2001 abdomen Minimally invasive Reverse 2 iontophoresis External on arm or 12 72 5 Retrospective No Yes Yes 2004 Minimally invasive Enzyme-tipped catheter Subcutaneous arm 2 12 72 5 Retrospective Yes No No — Minimally invasive Enzyme-tipped catheter Subcutaneous arm 1 1 72 1 Real time Yes FDA approved literature. A CGM can be used to evaluate 24-h blood glucose profiles in diabetic pa- tients who are receiving glucose-lowering drugs. Using Medtronic MiniMed’s Specifications of available and likely soon-to-be-available products for continuous glucose monitoring CGMS, Levetan et al. (8) and Abrahamian et al. (9) quantified the effect of pramlint- Biographer Monitoring System Gold Glucose Monitoring System Continuous Glucose Monitor ide and nateglinide on blood glucose, Table 1— Product GlucoWatch G2 Continuous Glucose GlucoDay No Yes 2001 Minimally invasive Microdialysis Subcutaneous abdomen 0 1 48 3 Real time or Guardian Telemetered PendraFreeStyle Navigator No Yes 2004respectively. Noninvasive Impedance 1232 DIABETES CARE, VOLUME 28, NUMBER 5, MAY 2005
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