Fran Kaufman TuDiabetes CGM


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  • Benefit of pump + CGM (not just CGM)This is the foundation for an artificial pancreas
  • Here’s how the feature works:User settable: On/OffLGS setting range: 40-110 mg/dL, default: 60 mg/dLWhen triggered, the feature suspends insulin infusion for up to 2 hours:Continuous audible alarm and continuous display of an emergency messageCan resume insulin delivery and cancel LGS at any timeCannot deliver a bolus when suspendedAfter 2 hours, pump resumes basal insulin delivery for 4 hours The 6-hour cycle will continue until LGS is cancelled or current calibration expires(Note: if asked about the 2 hour resume, it came from 23 million pump days analyzed in CareLink from 1/1/04-8/23/09. This was equal to 9,634,009 suspends with (281,270 for 2-3 hours and 270,454 for 3-5+ hours)
  • Fran Kaufman TuDiabetes CGM

    1. 1. The Use and Future Use of Continuous Glucose Monitoring Francine Ratner Kaufman, M.D. Distinguished Professor Emerita of Pediatrics and Communications, The Keck School of Medicine of the University of Southern CaliforniaCenter for Diabetes and Endocrinology, Children’s Hospital Los Angeles Chief Medical Officer of Medtronic Diabetes Los Angeles, CA •Medtronic 1 Diabetes
    2. 2. Meet Dr. Kaufman To register for a free copy of Insulin Pumps and Continuous Glucose Monitoring: A User’s Guide to Diabetes Management, visit: 2013-tudiabetes.html •Medtronic 2 Diabetes
    3. 3. CGM Completes the PictureFingerstick A1C Testing CGM Today’s diabetes management requires comprehensive understanding of glucose control. •Medtronic 3 Diabetes
    4. 4. More Information – MORE DATA with Continuous Glucose Monitoring NUMBER OF CONTINUOUS GLUCOSE READINGS PER105,120 YEAR (288 per day x 365 days) NUMBER OF FINGERSTICK MEASUREMENTS PER1,460 YEAR (4 per day x 365 days) •Medtronic 4 Diabetes
    5. 5. Continuous Glucose Monitoring Technology: Personal Use Personal CGM Paradigm and Guardian • For use by people with insulin-dependent diabetes • Real time displays of glucose values and trend graphs Allows You to Proactively • Retrospective data through CareLink Respond to Changes in Your Glucose Levels to Improve Control Real time CGM reveals fluctuations in your glucose levels that you can’t see through A1C tests alone*. •Medtronic 5Levetan C, et al. Diabetes Care 2003; 26:1-8 Diabetes
    6. 6. Site Differences in Glucose Testing: Interstitial Versus Capillary Meter Sensor mirrors its Sensor and meter are reading to match testing at different meter: a process called Sensor sites calibration Skin Interstitial Space Cells CapillaryMedtronic illustration: not to scale. •Medtronic 6 Diabetes
    7. 7. Continuous Glucose Monitoring Technology Glucose sensor readings 300 every 5 minutes (288/day) REAL-Time Trend Graphs reveal glucose patterns over timeGlucose – mg/dL 200 REAL-Time Trend Arrows show the direction and rate of glucose level changes 100 Target REAL-Time Alerts can be Zone customized to let people with diabetes know when they are out of range. 0 Offer’s three layers of protection: – Rate-of-Change Alerts 3AM 6AM 9AM 12PM 3PM 6PM 9PM – Predictive Alerts Time of Day – Low and High Alerts •Medtronic 7 * Levetan C, et al. Diabetes Care 2003; 26:1-8 Diabetes
    8. 8. Personal CGM Alerts Patients to Intervene to Avoid Dangerous High and Low Blood Glucose Fewer highs = less complicationsAlert Alert Alert Fewer lows = less accidents, coma, death •Medtronic 8 Diabetes
    9. 9. Medtronic CareLink™ Personal Reports •Medtronic 9 Diabetes
    10. 10. Safety and Comfort: Key Concepts for Success Most important for success. •Medtronic 10 Diabetes
    11. 11. Step 1: Set Low Sensor Glucose Alert Low SG Alert ONLY High SG Alert is OFF60 Alert sounds when Sensor Glucose is 60 mg/dl •Medtronic 11 Diabetes
    12. 12. Step 2: Set High Sensor Glucose Alert Turn on High SG Alert30060 •Range between High and Low Alerts is WIDE. •Focus on safety, while learning how to understand CGM trends. •Medtronic 12 Diabetes
    13. 13. Step 3: Tighten the Sensor Glucose Alerts Low SG Alert is 70 mg/dl High SG Alert is 250 mg/dl25070 • High and Low Sensor Glucose Alert thresholds are now closer to target range. • Adjust based on individual needs. •Medtronic 13 Diabetes
    14. 14. Step #4: Add High and Low Predictive Alerts Predictive Alerts occur BEFORE the threshold.25070 • Optional Alert setting. 1:33P HIGH PREDICTED • Start with 10 minutes for Predictive Alerts, then adjust as needed. •Medtronic 14 Diabetes
    15. 15. Integrated Insulin Pump with Built-In CGM is the Platform Upon Which the Artificial Pancreas Will Be Built A All Subjects 204 MDI MDI 8.5 216 SAPSAP * * 8.1% * * 8.0% 8.0% 7.9% 8.0 A1C (%) † ** † ** 7.6% 7.6% 7.4% 7.4% 7.4% 7.5 7.3% 7.5% 7.5% Study Phase Continuation Phase 7.0 0 3 6 9 12 15 18 Month •Medtronic *, P<0.001 for between-groups comparison; †, P<0.001 and ‡, P<0.05 for within-group comparison using the crossover group’s 12-month A1C value as the comparator. 15 Diabetes
    16. 16. Next Step: Threshold Suspend AutomationHow it Works:• User settable: On/Off 200• Threshold range: 60 - 90 mg/dL Sensor Glucose Values 160• Suspends at threshold for 2 hours 120 Resumes after 2 hours• During suspend: 80 • Patient can resume insulin delivery at any time 40 • No bolus ability• If sensor glucose value is below 0 threshold at 4 hrs after 30 90 150 210 resume, pump re-suspends Minutes insulin delivery •Medtronic Not approved in the U.S. Currently under FDA review. 16 Diabetes
    17. 17. The Steps to the Artificial Pancreas Combines hardware, software and algorithms to shift control from patient and lessen variability of glucose Treat to Range Closed Loop Out of Range Closed Loop Closed Loop at Night Threshold Suspend Automation •Medtronic Predicted Low GlucoseFuture Product Concepts Not approved in the U.S. 17 Management Diabetes
    18. 18. And Around the World – What are we doing? Kazakhstan •Medtronic 18 Diabetes
    19. 19. And Around the World – What are we doing? Haiti •Medtronic 19 Diabetes
    20. 20. •Medtronic 20Diabetes
    21. 21. ConclusionsIntegrated Insulin Pump with Built-In CGM– Providing a wealth of data and personalized alerts and alarms can help you prevent dangerous highs and lowsThe Iterative Steps to the Artificial Pancreas– CGM is the foundation upon which the artificial pancreas will be built– Medtronic is taking iterative steps of automation to work toward the ultimate goal of bringing to market a fully automated artificial pancreasAdvocating for the Global Diabetes Community– We can help by contributing our time, money and talents to organizations that work to improve education, understanding and resources for people living with diabetes around the globe •Medtronic 21 Diabetes
    22. 22. Questions???? •Medtronic 22 Diabetes