Glucose Monitors and Glucose Sensing

Applications for the 21st Century and Beyond The Quest for the Closed Loop

Why Glucose Sensing??
‡ More ³real time´ assessment ‡ Ability to detect hypoglycemia and hyperglycemia at ³odd´ times ‡ Better administration and correlation of insulin dosages²less guessing ‡ May uncover eating disorders and other issues related to stress, diet and exercise ‡ Patient compliance with monitoring an issue± many do not like to ³poke´ fingers or other sites so often. Pain and discomfort, lack of blood obtained, lost strips, etc.

Why Glucose Sensing??
‡ Goal± Closing the Loop ‡ An artificial pancreas ‡ Provide accurate and specific data to control glucose levels ± many individuals keep blood glucoses higher than optimal to avoid hypoglycemia ‡ Fear of hypoglycemia in the middle of the night± not waking up ‡ ³Take the worry´ out of diabetes treatment ± Type 1 patients in particular; parents, children and physicians

Optimal Conditions for Glucose Measurement
‡ Immediate availability of results and measurements ‡ High frequency of measurements
± Measurements every 2-5 minutes would be ideal ± Ability to detect rapid rise or decline is necessity

‡ Need quick signal stability after initiation or placement ‡ Stability over prolonged period of time (>3 days necessary)

extracorporeal electrochemical sensor ± signal needed to be corrected for fluid transportation ± 31 minutes (lag time) Diabetes Care 24: 1696.Case for Glucose Sensing ± Recent Studies ‡ 23 patients participated ± hospitalized and ambulatory ‡ Both Type 1 and Type 2 individuals ‡ Study lasted 72 hours (key time limit) ‡ 75 capillary samples were obtained ‡ Microdialysis subcutaneous monitoring system used ± microdialysis catheter. 2001 Jungheim et al .

Results of Study and Conclusions ‡ Studies showed no limitations to patients activity and only mild skin irritation ‡ Difference between SCGM and capillary glucose was ~ 7-9 % over the full range (meter differences can be as much as 10 ± 15 %) ‡ Hypoglycemia was detected with SCGM but was missed 58-71% of the time by spot capillary measurements. This despite 5-7 or more measurements per day ‡ No decay in sensitivity over the 72 hour period ‡ SCGM could be useful in glucose control & therapy .

Glucose Monitor Development Race for the Closed Loop System. Continuous and the ³Gold´ . Painless.

Types of Monitors in Development ‡ Minimally invasive interstitial devices ‡ Transcutaneous optical devices ‡ Electrochemical sensing devices ± subcutaneous ± Implantable ‡ Implantable optical sensors .

etc.) can dilute the measurements and adversely affect the results as sample size is small .Physiology of Interstitial Fluid ‡ Extracellular fluid and flows through the capillary walls ‡ Glucose levels in interstitial fluid  blood glucose ‡ Lag time could be ~ 10 to 20 minutes ‡ Perspiration. oils and other environmental factors (lotions.

com .Interstitial Glucose Sensor Glucowatch Biographer 2 Cygnus Corp: www.glucowatch.

Glucowatch Schematic .

perspiration and if system is bumped or dislodged ± If several readings in a row are skipped. the system must be recalibrated ‡ Alerts patients to rapids changes in glucose levels ‡ Less painful?? ‡ Computer download capable ‡ ? Ability to determine insulin or medication adjustmens .Advantages and Limitations of Glucowatch System Advantages ‡ Non-invasive ‡ Detects trends and patterns in glucose levels ± readings every 10 minutes with up to 6/hour = 72 readings/monitoring session Limitations ‡ 2 hour ³warm-up period ‡ Calibration is needed with each sensor use ‡ Skin irritation with sensor and adhesive ‡ Skipped readings possible with rapid changes in temperature.

to supplement. information obtained from traditional and standard home glucose monitoring devices! .Use of Glucowatch Biographer 2 ‡ Intended for use in adults and children to detect trends and patterns in glucose levels ‡ To detect and assess hyperglycemic and hypoglycemic patterns to help facilitate adjustments in therapy ‡ To be used as an adjunctive device. not replace.

Glucowatch Biographer 2 ‡ Draws out interstitial fluid by reverse electroionophesis ‡ Glucose interacts with Glucose Oxidase Membrane to form hydrogen peroxide which interacts with biosensor producing low electric current which is measured and analyzed ‡ Glucowatch 2 ± Cost $599 to $799 ± Rebates can save $200 to $300 ‡ Auto sensor ± ± ± ± Disposable transdermal pad Changed every 14-15 hours ~$4 each (2 needed) for each recording session Concerns with calibration time. risk of infection and irritation .

Glucose Collection with the GlucoWatch® G2Œ Biographer Uses Reverse Iontophoresis ‡ Only small compounds pass through the skin... neutral species (i. CATHODE ANODE ± No proteins (e. hemoglobin) in the extract ‡ Glucose is collected at the cathode. 2002. (ascorbate.g. glucose) ‡ The charge and size exclusion properties of reverse iontophoretic extraction will lead to a very ³clean´ sample. . Cygnus Inc. urate) Na+. Data on file. ± Interfering species (ascorbate and urate) collected at anode Cl-.e.

The Automatic Monitoring Process with the GlucoWatch® G2Œ Biographer * A ³RUNNING AVERAGE´ PROVIDES READINGS EVERY 10 MINUTES ‚3 min Á7 min ‚3 min Á7 min ‚3 min Á7 min ‚3 min Á7 min Internal measure 127 mg/dL 109 mg/dL 101 mg/dL 112 mg/dL Displayed reading TIME ‚3 118 mg/dL 3:10 pm 3:20 pm 105 mg/dL 3:30 pm 107 mg/dL 3:40 pm * Following a 2 hour warm-up and calibration min glucose collection Á 7 min glucose measurement Data on file. . Cygnus Inc. 2002.

Difference greater than 20% but Biographer would not lead to bad decision 150 D B D 100 50 (C) Might cause an over-correction of normal glucose levels. Intercept = 12.1% 2996 paired points A B C 350 E C Biographer Readings (mg/dL) 300 D E 250 200 B (A) Accurate. Biographer within 20% of finger-stick test result (or both below 70 mg/dL) (B) Acceptable.GlucoWatch® Biographer Home Study ± Clarke Error Grid Analysis Slope = 0. (D) Failure to detect a high or low glucose level. Biographer reading low when finger-stick blood glucose is high or Biographer reading high when finger-stick is low. 2002.95. New Brunswick New Jersey Data on file. Finger-stick blood glucose test result in the normal range. Cygnus Inc. . Biographer reading in the normal range. but Biographer reading is high or low. but fingerstick blood glucose test result is high or low C 0 0 100 ® Profile ® Touch 200 E 300 400 One One Touch Profile ® ® * Glucose Readings (mg/dL) (E) Treatment error could occur. r = 0.80 400 ZONE A Biographer Readings 60% 34% 1% 4% 0. * One Touch® Profile® ± Johnson and Johnson.6 mg/dL.

2 minutes 7 minutes with Glucowatch ‡ Time lag: 13 minutes with most blood glucose meters ‡ With glucose increasing.Studies of Glucowatch vs. Meters ‡ Differences between interstitial fluid and blood glucose ‡ Time lag: 17. changes were greater as measured by Glucowatch as compared with blood or meters ‡ Conclusion: possible false hyperglycemia and false hypoglycemia if taken unilaterally Kulcu et al: ADA Meeting 2002 . changes were less as measured by Glucowatch as compared with blood ‡ With glucose decreasing.

spectrx.com .SpectRx Glucose Sensing System ‡ ‡ ‡ ‡ ‡ ‡ ‡ Transdermal Biophotonic System Fluid is collected through micropores Laser system used on the outer layer of skin Measured in a patch which contains a glucose sensor Clinical trials are ongoing Is not FDA approved at this time Still similar to Glucowatch in that it provides information on trends and not necessarily real-time for treatment adjustments SpectRx website: www.

com .SpectRx Glucose Sensing System Laser device on the skin surface Patch with sensor system embedded www.spectrx.

spectrx.com .Preliminary data with SpectRx ISF System www.

Preliminary data with SpectRx ISF System .

Pendragon Glucose Sensing System ‡ Uses electromagnetic waves ‡ Attached to lower forearm similar to the Glucowatch ‡ Performs measurements every minute but averaging occurs .

Pendragon Glucose Sensing System .

Recent Study with PENDRA ‡ 15 individuals without diabetes ‡ Changes in microcirculation of the arms resulted in varying glucose values ‡ Temperature changes. 2004 . other environmental issues had to address via a complex calibration procedure ‡ Conclusions: ± Need to ³fix´ device appropriately to arm to avoid possible variations ± Needs extensive physician and patient training to operate ± Needs further studies prior to any extensive use in the clinical setting Diabetes Technology and Therapeutics 6:435.

Electrochemical Glucose Sensors CGMS TGMS DexCOM .

reliability just 48 to 72 hours .Continuous Glucose Monitoring System--CGMS ‡ Basic Premise: Glucose + Oxygen = Gluconic Acid + H 2O 2 ‡ Reaction is submitted to an electrical current which is proportional to the glucose concentration which is measured ‡ Enzymatic or Electrochemical Sensors are implanted in the subcutaneous tissue (under the skin) ‡ Similar to the catheters used in insulin pump therapy ‡ Short term use at present.

Medtronic (MiniMed) CGMS System

Two Views of CGMS

Mechanism of Action of CGMS

Enzymatic Reaction is measured by sensor in IF through skin

CGMS System

‡ Sensor is percutaneous an ~1mm in diameter ‡ Measures an ³average´ glucose value every 5 minutes and is stored in the monitor ‡ ³Hard´ wired system; worn externally ‡ Requires calibration at 4-5 times per day, otherwise data is not able to be downloaded ‡ Able to enter events on the monitor to assist with interpretation of results ‡ 3 day use only at this time ‡ Not ³real time´²requires return to physician office for download and interpretation

CGMS System

‡ Problems with encapsulation tissue which can cause errors in data collection ‡ Anything implanted in the body over time becomes covered with a protein layer initially and then a collagen like layer ‡ Encapsulation tissue is to protect the body from foreign objects which may be perceived as harmful and to isolate the object chemically (ie.²broken port in pulmonary artery) ‡ This chemical isolation could decrease the sensitivity and response time of electrochemical subcutaneous systems such as CGMS

et al: Diabetes Care 25:1185. July 2002     Self monitoring of glucoses several times per day will leave ³gaps´± ³gaps´± large excursions can occur without patient knowledge Hypothesis: to test the reproducibility of the CGMS in ³real³real-life setting´ CGMS may be a tool that could alleviate this difficulty System measures glucose concentration every 5 minutes for a 72 hour period       Preliminary Study ± performed in Type 2 patients ~ 150 separate glucose tracings Included healthy volunteers and patients on only metformin Correlated with frequent blood glucose measurements Noted exceeding high incidence of hypoglycemic events with no symptoms and not confirmed by simultaneous blood glucose measurements Correlation coefficient ±r=0. M.CGMS± CGMS± Reproducibility Study Metzger.74 .

CGMS± CGMS± Reproducibility Study Metzger. M. July 2002        ³Real Life Study´ was undertaken to determine accuracy and reproducibility of tracings utilizing the CGMS device 11 patients involved in the study 6 had Type 1 diabetes 3 had Type 2 diabetes 2 ³healthy´ volunteers with no history of DM 10 male. 1 female Placed on two glucose sensor devices simultaneously for a 3 day period with usual ³normal´ activity . et al: Diabetes Care 25:1185.

July 2002       Protocol ± Sensors were attached according to the manufacturer¶s instructions Sensors were placed in the abdominal SQ tissue 4-5 cm to 4the right or left of the umbilicus Calibration and Initialization were performed and 1 hour was elapsed before first capillary glucose Meal times were recorded Capillary glucoses were done immediately post meals.CGMS± CGMS± Reproducibility Study Metzger. M. et al: Diabetes Care 25:1185. during the night and early AM Capillary glucoses were entered into the monitor within 5 minutes of determination .

M. et al: Diabetes Care 25:1185. July 2002EA Download was done upon completion and analysis was performed immediately  Anonymity was preserved  Each day was divided into 8 time intervals according to the meal times of the patient  Classifications:  ± ± ± ± A: Satisfactory B: if all glucose values are between 80 ±150 C: glucose > 150 during >1 hr.. too low D: glucose < 70 during >30 minutes or impossible to evaluate due to technical reasons .CGMS± CGMS± Reproducibility Study Metzger.

July 2002  D Classification was further subclassified: ± D1: Low concordance between sensor and glucometer r < 0.  Evaluations were analyzed by two different observers independently and concordance rates were determined .CGMS± CGMS± Reproducibility Study Metzger. Usually secondary to insufficient number of calibration values.8 or the difference is too high (28%) ± D2: Insufficient number of meter glucose values entered for calibration ± D3: Strong midnight shift: usual sensor glucose values post midnight. et al: Diabetes Care 25:1185. M.

± 92 from Type 1 patients ± 30 from Type 2 patients ± 17 from non-diabetes volunteers non- . M.9 hours each patient 432 single time intervals were initially evaluated  78 (18%) were discarded for technical reasons  ± 32 due to interpretable  139 paired sets of data were available for sensor-sensor sensorcomparison. July 2002  Mean sensor not recording glucose values ± 46 classified in the ³D´ group and not use of sensor: 60.4 16.CGMS± CGMS± Reproducibility Study Metzger. et al: Diabetes Care 25:1185.

et al: Diabetes Care 25:1185. M. sensor 2 showed hypoglycemia No difference between patients with DM and non DM .CGMS± CGMS± Reproducibility Study Metzger. July 2002      Concordance was seen in only 65% of the time periods 25% noted glucose levels too high in one sensor and satisfactory in the other 9% noted glucose levels too low with satisfactory levels in the other 1 case noted: sensor 1 showed hyperglycemia.

CGMS± CGMS± Reproducibility Study Metzger.84 vs. sensor (r = 0. M. July 2002  Conclusions: ± Accuracy and reproducibility is lower than previously thought ± Differences were greatest between the 125 and 225 mg/dl range ± most important area in treatment of patients with diabetes mellitus ± Correlation between two simultaneous sensors was lower than that of capillary vs.90) . et al: Diabetes Care 25:1185. 0.

July 2002  Conclusions: ± 35% clinically important discrepancies between two simultaneous sensor tracings ± Could result in incorrect clinical advice in 17% of patient cases ± @ RESULTS OBTAINED IN ³REAL LIFE´ SITUATIONS MUST BE INTERPRETED IN INDIVIDUAL CLINICAL TERMS .CGMS± CGMS± Reproducibility Study Metzger. et al: Diabetes Care 25:1185. M.

July 2002    Development of a reliable device for continuous glucose monitoring is of outmost importance in the treatment of diabetes Future endeavors in this area must be rigorously evaluated in ³real life´ situations before release to the general public Rebuttal from Medtronic ²concerns in the above study: software used was earlier version.CGMS± CGMS± Reproducibility Study Metzger. M. device was used for more than planned or approved . et al: Diabetes Care 25:1185.

3 Type 2 Measured Glucoses with 1 Touch Ultra 7 times per day Wore 2 sensors (CGMS) concurrently for 3 days Mean Sensor life: 67 hours Used updated software Found accuracy with newer software ~94% Most of differences between modalities within 10% Sensor-sensor differences less than previous study . 6 Type 1.Additional Studies--2003 Studies--2003          Armstrong and King: ADA Meeting 2003 11 subjects: 2 No Diabetes.

when used with home monitoring devices and HbA1C values can help optimize clinical management Mastrototaro and Gross. Diabetes Care 26:256 2003 . 2000) CGMS is intended to ³supplement.Rebuttal to Metzger Findings       Expectations did not coincide with CGMS intended use Study did not use Clarke error grid but was one of subjective assessment Study did use updated software (Solutions 3.0) Results are similar to those reported in the postmarketing studies (Diabetes Technology and Therapeutics. not replace. blood glucose information using standard monitoring devices´ CGMS.

Diabetes Care 26:256 2003 .0 software resolves most of the 18% rate of technical problems encountered in the study ± Correction of the midnight shift ± Improvement in the accuracy and reproducibility of the downloads ± Improvement in the agreement between sensor and meter values Mastrototaro and Gross.Rebuttal to Metzger Findings  Solutions 3.

Rebuttal to Metzger Findings   CONCLUSIONS: Results should be weighed against the encouraging results and conclusions from previous and evolving reports and research Appears that this is a work in progress and should not be utilized as the sole clinical indicator! ± should not be used at present as the only source for change in treatment regimens -Speakers judgment after reviewing literature   .

Sample CGMS Reports Daily Report of Blood Glucoses .

Sample CGMS Reports Modal Time Reports± Can be varied individually .

Sample CGMS Reports Composite 3 day report for comparison .

Additional Studies Involving Children ‡ Accuracy of Glucowatch 2 system and CGMS in detecting hypoglycemia ‡ Multi-center study ‡ Involved the Children in Diabetes Research Network ‡ 91 children enrolled ‡ Ages 3-17 ‡ Patients were enrolled in a CRC-clinical research center for 24 hours Diabetes Care 27:722-726 2004 .

CGMS ‡ Patients used CGMS and Glucowatch 2 during each admission ‡ 1/3 patients started CGMS 48 hours prior to admission ‡ 1/3 patients started CGMS 24 hours prior to admission ‡ 1/3 patients started CGMS on the day of admission ‡ Each patient used 2 sensors for the G-watch 2 during the study± 2 hour overlap ‡ 1 Touch Ultra meter used as calibration and control .Glucowatch 2 vs.

5 minutes .5 minutes ± CGMS ± 2. CGMS ‡ Samples: every hour during the day every 30 minutes during the night ‡ Hypoglycemia induction test: samples obtained every 5 minutes for 90 minutes ‡ Adjustment of values for lag time: time involved in sampling the interstitial fluid measuring glucose as compared with blood ± Glucowatch 2 Biographer± 17.Glucowatch 2 vs.

CGMS Results of Study ‡ Glucowatch 2 Biographer ± ~ 23 % of values were within reference range when glucoses were < 60 mg% ± 51% false alarms were detected with use ‡ CGMS System ± Both modified and original sensors noted < 50% detection within reference range (36 and 48 %) ± 58% to 60% false alarms were detected with use .Glucowatch 2 vs.

Study Conclusions ‡ Neither Glucowatch 2 nor CGMS is accurate in reporting glucose values in the hypoglycemic range ‡ Accuracy of both devices is better when reference glucose levels are >100 mg/dl ‡ Neither device is appropriate at this time for real time detection ‡ Both systems are more likely to be of value in adjusting bolus and basal insulin doses in patients with consistently elevated glucoses and A1C levels ‡ The accuracy of these early generation sensors is similar to the early generation meters (circa 1970s-early 1980s) .

Modified Home Use of CGMS² Guardian System .

Guardian Home System ‡ Sensor can be set to ³alarm´ at certain levels both high and low ‡ Monitor can be placed up to 6 feet away. does not have to be worn ‡ Monitor can store up to 21 days of data ‡ Can be downloaded to personal computer ‡ Still needs calibration similar to CGMS system ‡ Alerts or alarms need to be verified with ³finger stick´ glucose ‡ Cost is not set at present (~ $800.$1500 anticipated) .

com .minimed.Anticipated Sample Guardian Report Reports similar to CGMS System www.

Radio Transmitter and Pump receiver ‡ Abstract presented at ADA 2004 (Orlando) ‡ 9 Patients involved.Paradigm 522 System± Patient Use ‡ Consists of Glucose Sensor. Ages 10-21.3% ‡ Glucoses decreased average 20 mg% ‡ Work in progress. Type 1 DM ‡ Used CSII ‡ Did 4 Blood Glucoses/day via HGM ‡ Wore 7 sensors during the 3 week trial ‡ A1C levels decreased 0. Not available yet!!! .

Implantable Subcutaneous Systems Enzyme electrode system Electrochemical device .

DexCom Subcutaneous Sensor System Implantable Sensor device Pager monitoring system .

2-38. 2004 Endocrinology Clinics NA 33:175. 2004 .9 mmol/L) ‡ Recalibration every 20 days ‡ 160 ± 180 day lifespan for sensor ‡ Still need to do HGM 2-3 times/day to initiate glucose algorithm ‡ Easily implanted in subcutaneous tissue ‡ Can be accomplished as outpatient procedure Diabetes Care 27:734.DexCom Subcutaneous Sensor System ‡ Special bioprotective layer prevents foreign body reaction with sensor ‡ Can measure glucoses ranging from 40 mg/dl to 700 mg/dl (2.

Therasense Navigator System ‡ Interstitial System ‡ Wireless system ‡ Needs calibration 1-2 times per day ‡ Readings every 1-2 minutes conceptualized ‡ High and low glucose alarms to be incorporated ‡ Currently experimental ‡ Company not distributing info at this time .

Near Infrared Spectroscopy Non-invasive techniques .

Sensys Medical Systems Endocrinology Clinics of NA 33: 163-173 2004 .

5 pounds ‡ Fiber-optic head secured to the forearm ‡ Still needs HGM for calibration ‡ Various components such as sweat. can interfere with efficacy ‡ Can use either volar or dorsal aspects of the forearm ‡ Uses a rechargeable battery ‡ Studies ongoing with patient use . etc. fat.Sensys Medical Systems ‡ Measures glucose non-invasively via NIR spectroscopy ‡ Device weighs less than 1.

Open-flow Microperfusion Systems ADICOL ProjectDisetronic/Roche Advanced Insulin Infusion with a Control Loop .

ADICOL Project ±Disetronic / Roche ‡ Inserted into the subcutaneous adipose tissue ‡ Double lumen catheter ‡ Acquires glucose readings every 30 minutes ‡ Goal ± subcutaneous glucose sensing/insulin delivery system .

ADICOL Project ±Disetronic / Roche Large bore catheter Readings only every 30 minutes Small study sample with patient use .

Infrared Spectroscopy Animas Corporation Continuous Glucose Monitoring System .

one could delineate the species and concentration ‡ In reality± this is difficult ± Water absorbs most IR light ± Blood scatters light ± Different species overlap in their spectra or footprint . wavelength.Infrared Spectroscopy ‡ Infrared light is absorbed by molecules ‡ Each molecule has its own spectra (absorption characteristic)²similar to its own footprint ‡ Theoretically-by measuring the absorbed light vs.

012 0.5 1.8 0.2 2.9 2.3 0.7 1.1 2.8 1.040 0.7 1.8 1.7 1.036 0.018 0.054 0.060 0.4 0.028 0.9 2.9 2.042 0.004 1.056 0.2 1.8 Hemoglobin Absorbance 1.5 1.062 0.3 1.6 1.2 1.2 1.2 1.8 Wavelength (microns) Absorbance 2.6 1.046 0.0 0. Blood & Glucose Absorbance 0.050 0.6 1.024 0.020 0.2 Absorbance Blood Glucose 2.0 2.4 0.0 0.2 2.038 1.8 1.2 1.038 0.6 1.040 0.1 2.4 1.3 Wavelength (microns) mic Wavelength (microns) .0 1.6 2.6 1.1 2.6 2.0 2. Hemoglobin.008 0.3 1.0 2.014 0.4 1.0 1.058 0.7 1.052 0.8 1.030 0.4 1.010 0.4 1.0 2.4 2.022 0.6 1.0 2.034 0.6 0.1 2.2 mic Wavelength (microns) 0.2 0.048 0.3 1.042 0.5 1.044 0.2 2.9 2.016 0.006 0.026 0.4 1.2 Water 1.Spectra of Water.3 1.2 2.4 1.0 0.5 1.032 0.3 1.2 0.8 1.3 1.

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Sketch of Animas Sensor .

Implanted Extravascular Sensor Head .

Early Animas Sensor Head .

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Correlation (r2=.94) between optical and conventional means (500 people) C o n c e n tr a tio n (m g /d l). u s in g O p tic a l M e a n s 450 400 350 300 250 200 150 100 50 0 0 50 100 150 200 250 300 350 400 450 Concentration (mg/dl) Determined by Glucometer .

Time 350 Glucose Concentration (mg/dl) 300 250 200 150 100 50 0 Glucometer Sensor Time .In vivo Measurements in Dog: Glucometer and Sensor Head vs.

Animas Continuous System ‡ Has designed and built short term prototype and demonstrated stability in animals ‡ Need to miniaturize system ± Laser diodes under development ± Telemetry developed ± Electronics being modified and mostly developed ‡ Clinical trials in humans projected to start 2005 or 2006. Projected as early Phase 2 studies with sites to be determined. No pediatric patients to be involved! .

ocular fluid y The encapsulation/ fibrin tissue has no effect on monitor accuracy y Provides direct access to blood.Advantages of Animas Monitor y Provides continuous reading of blood glucose without patient intervention y Measures glucose in blood as opposed to some other body fluid. No percutaneous wires or cables are utilized. limited by battery life. e. obviating loss and interference associated with light transmission through intervening tissues. interstitial fluid. y Sensor stays implanted for at least 5 years. .g.

What is the Goal of These Technologies? Development of a Closed Loop System± The Artificial Pancreas *Put the Endocrinologist into Early or Permanent Retirement .

Have We Achieved Goal??? Not Yet!! .

What Has Been Accomplished? ‡ New Technology to determine patterns and facilitate changes in therapy ‡ Prototypes for long term glucose monitoring ‡ More awareness by patients and families regarding the importance of intensive therapy and ³tight´ control of blood glucoses ‡ ³Consumer driven´ research for an artificial pancreas ‡ More physicians are implementing intensive therapy with technology now available to compliment the treatment .

ONE ONLY KNOWS! . there are 50+ companies or individuals attempting to develop a continuous glucose monitoring system ‡ EVENTUALLY. THAT DAY WILL ARRIVE!! WHEN.Final Thoughts ‡ No system at present is appropriate for a closed loop system ‡ No system developed at present can replace the ³finger stick´ monitor for ³real time´ glucose values and treatment decisions ‡ Presently.

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