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Continuous Glucose Monitoring Systems CGSM

9/4/2012. 2. Agenda. IntroductionBrief HistoryDisease OverviewDiabetes AssessmentSelf Monitoring Blood Glucose SystemContinuous Glucose Monitoring SystemNext-StepConclusion. 9/4/2012. 3. Introduction. Diabetic Population20.8 million people1.5 million new cases in 20056th leading cause of

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Continuous Glucose Monitoring Systems CGSM

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    1. 9/4/2012 1 Continuous Glucose Monitoring Systems (CGSM) Byron Chun

    2. 9/4/2012 2 Agenda Introduction Brief History Disease Overview Diabetes Assessment Self Monitoring Blood Glucose System Continuous Glucose Monitoring System Next-Step Conclusion

    3. 9/4/2012 3 Introduction Diabetic Population 20.8 million people 1.5 million new cases in 2005 6th leading cause of death Market $132 billion total annual economic cost 11% US Healthcare Expenditure $1.5 Billion Market potential for GMS $3.0 billion World Wide $2500 material costs per patient

    4. 9/4/2012 4 Brief History 1922 Urinary Glucose Monitoring availability of insulin 1978 First Self-Monitoring Blood Glucose (SMBG) 1999 FDA Approval of 1st Continuous Glucose Monitoring Systems (CGMS) MiniMed Medtronic

    5. 9/4/2012 5 Physiological Overview

    6. 9/4/2012 6 Diabetes Overview Set of diseases that prevents the body from regulating Glucose (sugar) properly

    7. 9/4/2012 7 Diabetes Overview – Cont. Type-1 Diabetes 5-10% of Diabetes Population Cause: Auto immune disease – Beta Cells Little to no insulin produced Constant Care: Glucose Monitoring, Insulin Injections Type-2 Diabetes 90-95% of Diabetes Population Cause: Obesity, Sedentary lifestyle Body unable to use Insulin properly Exercise, Healthy Diet, Weight loss Gestational 4% of Pregnancy's

    8. 9/4/2012 8 Effects of Diabetes Long term Effects Blindness Kidney Failure Nerve damage Thrombus Formation Heart Disease, Heart Attacks, Stroke Short Term Effects Hyperglycemia Stroke, Heart attacks (ketones) Hypoglycemia Fainting, Seizures

    9. 9/4/2012 9 Testing Methods Blood Glucose Levels Small Window Normal 80-120 mg/dl Hypoglycemia < 70 mg/dl Hyperglycemia > 140 mg/dl Hemoglobin A1c Big Picture Excess Glucose attached to A1c of RBC Normal < 7% Dramatically reduce complications

    10. 9/4/2012 10 SMBG System 33% of Diabetes Population Over 25 models on the Market 4-7 Tests per day Advantages Accurate Effective Fast Compact Disadvantages Painful Incomplete Glucose Profile

    11. 9/4/2012 11 CGMS Overview Class II – Medical Device Approved by FDA in February of 1999 1st device to monitor Blood Glucose Continuously! Goals: Supplement data gathered by SMBG systems. Provide Glucose profile to improve treatment. Minimize Hyper & Hypoglycemic excursions.

    12. 9/4/2012 12 CGMS Readings Capabilities Records glucose levels every 10 seconds Averages this data every 5 minutes 288 Glucose points a day Able to log calibration time and other events Recommended Observation Time 1-3 days Capable of storing 14 days of data

    13. 9/4/2012 13 CGMS Components Disposable Glucose Sensor Connector Cable Monitoring Unit Com-Station Test plug

    14. 9/4/2012 14 CGMS Sensor Components: sterile glucose sensing electrode glucose oxidase polyurethane tube rigid introducer needle base w/ electrical connector contact pads external electrical connector adhesive patch

    15. 9/4/2012 15 CGMS Monitor Components Power source Integrated Circuitry Infrared Com-Port Cable Connector LCD display Keypad buttons

    16. 9/4/2012 16 Regulatory Aspects FDA Classified Class II – Medical device Verification of Safety and Efficacy Sterilization Electron Beam Sterilization Validated using ISO 11137 Specifications Failure Analysis Environmental – Mechanical Vibration Stress & Wear – Insertion Force Package integrity – Dust drum package challenge

    17. 9/4/2012 17 Regulatory Aspects Verification of Safety and Efficacy Cont. Biocompatibility Testing - Short-term contact Sensor Tube & Polyurethane Tubing

    18. 9/4/2012 18 Clinical Trials Validation of Safety and Efficacy Post-Market/Independent Trials are Valuable! Efficacy of CGMS on Children using a CSII system 36 type 1 diabetes patients, under the age of 18 Both CSII control group & CGMS had improved A1c levels. Improvement A1c levels in CGMS group were attributed to extended Hypoglycemic excursions. Conclusion: CGMS regimented treatment was ineffective in improving diabetic conditions of children due to their unstable activity and dietary nature. Must chose target population for devices carefully!

    19. 9/4/2012 19 Next-Step Translate shortcomings into strength CGMS System No concurrent glucose display No hyper/hypoglycemic alarms No trend analysis No interface with Insulin injector Limited mobility (cable) Non-waterproof housing Paradigm REAL-Time Insulin Pump & CGMS Displays real-time glucose levels Gycemic Alarms Trend analysis displayed graphically Automated Insulin Injection Improved mobility with wireless Sensor/Monitor connection Robust waterproof packaging

    20. 9/4/2012 20 Conclusion The CGMS signifies a key step in moving towards a closed-loop insulin injection system. It is important to observe potential improvements in medical devices and act on them. (While balancing risk and FDA regulations of course!)

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