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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 California
Center for Diabetes and Endocrinology, Children’s Hospital Los Angeles
              Chief Medical Officer of Medtronic Diabetes
                            Los Angeles, CA
                                                          •Medtronic
                                                                   1
                                                          Diabetes
Meet Dr. Kaufman




                   To register for a free copy of Insulin
                     Pumps and Continuous Glucose
                       Monitoring: A User’s Guide to
                       Diabetes Management, visit:
                   http://info.medtronicdiabetes.com/
                           2013-tudiabetes.html
                                              •Medtronic
                                                       2
                                              Diabetes
CGM Completes the Picture




Fingerstick                                       A1C
    Testing




                            CGM
      Today’s diabetes management requires comprehensive
                understanding of glucose control.       •Medtronic
                                                                3
                                                      Diabetes
More Information – MORE DATA
  with Continuous Glucose Monitoring
                            NUMBER OF
                            CONTINUOUS
                            GLUCOSE
                            READINGS PER


105,120                     YEAR
                            (288 per day x 365
                            days)



             NUMBER OF FINGERSTICK
             MEASUREMENTS PER
1,460        YEAR
             (4 per day x 365 days) •Medtronic
                                             4
                                    Diabetes
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
                                                                                 5
Levetan C, et al. Diabetes Care 2003; 26:1-8                         Diabetes
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




                                              Capillary


Medtronic illustration: not to scale.
                                                                                 •Medtronic
                                                                                          6
                                                                                 Diabetes
Continuous Glucose Monitoring Technology

                                                                                            Glucose sensor readings
             300                                                                            every 5 minutes (288/day)
                                                                                            REAL-Time Trend Graphs
                                                                                            reveal glucose patterns over
                                                                                            time
Glucose – 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
Personal CGM Alerts Patients to Intervene to
  Avoid Dangerous High and Low Blood Glucose


                       Fewer highs = less complications


Alert                               Alert




               Alert

                                  Fewer lows = less accidents, coma, death


                                                          •Medtronic
                                                                   8
                                                          Diabetes
Medtronic CareLink™ Personal Reports




                                  •Medtronic
                                           9
                                  Diabetes
Safety and Comfort: Key Concepts for Success




   Most important for success.

                                    •Medtronic
                                             10
                                    Diabetes
Step 1: Set Low Sensor Glucose Alert

                            Low SG Alert ONLY
                           High SG Alert is OFF



60


     Alert sounds when Sensor
        Glucose is 60 mg/dl


                                         •Medtronic
                                                  11
                                         Diabetes
Step 2: Set High Sensor Glucose Alert
                           Turn on High SG Alert
300




60

       •Range between High and Low Alerts
       is WIDE.
       •Focus on safety, while learning how
       to understand CGM trends.
                                              •Medtronic
                                                       12
                                              Diabetes
Step 3: Tighten the Sensor Glucose Alerts
                        Low SG Alert is 70 mg/dl
                       High SG Alert is 250 mg/dl
250




70


       • High and Low Sensor Glucose Alert
       thresholds are now closer to target
       range.
       • Adjust based on individual needs.
                                             •Medtronic
                                                      13
                                             Diabetes
Step #4: Add High and Low Predictive Alerts
                        Predictive Alerts occur
                        BEFORE the threshold.
250




70


                         • Optional Alert setting.
      1:33P HIGH
       PREDICTED         • Start with 10 minutes
                         for Predictive
                         Alerts, then adjust as
                         needed.          •Medtronic
                                                   14
                                          Diabetes
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
Next Step: Threshold Suspend Automation

How 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
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 Glucose
Future Product Concepts Not approved in the U.S.
                                                                              17
                                                       Management Diabetes
And Around the World – What are we doing?
               Kazakhstan




                                  •Medtronic
                                           18
                                  Diabetes
And Around the World – What are we doing?
                 Haiti




                                  •Medtronic
                                           19
                                  Diabetes
•Medtronic
         20
Diabetes
Conclusions


Integrated Insulin Pump with Built-In CGM
– Providing a wealth of data and personalized alerts and alarms
  can help you prevent dangerous highs and lows
The 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
  pancreas
Advocating 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
Questions????




                •Medtronic
                         22
                Diabetes

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Fran Kaufman TuDiabetes CGM

  • 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 California Center for Diabetes and Endocrinology, Children’s Hospital Los Angeles Chief Medical Officer of Medtronic Diabetes Los Angeles, CA •Medtronic 1 Diabetes
  • 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: http://info.medtronicdiabetes.com/ 2013-tudiabetes.html •Medtronic 2 Diabetes
  • 3. CGM Completes the Picture Fingerstick A1C Testing CGM Today’s diabetes management requires comprehensive understanding of glucose control. •Medtronic 3 Diabetes
  • 4. More Information – MORE DATA with Continuous Glucose Monitoring NUMBER OF CONTINUOUS GLUCOSE READINGS PER 105,120 YEAR (288 per day x 365 days) NUMBER OF FINGERSTICK MEASUREMENTS PER 1,460 YEAR (4 per day x 365 days) •Medtronic 4 Diabetes
  • 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 5 Levetan C, et al. Diabetes Care 2003; 26:1-8 Diabetes
  • 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 Capillary Medtronic illustration: not to scale. •Medtronic 6 Diabetes
  • 7. Continuous Glucose Monitoring Technology Glucose sensor readings 300 every 5 minutes (288/day) REAL-Time Trend Graphs reveal glucose patterns over time Glucose – 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. Personal CGM Alerts Patients to Intervene to Avoid Dangerous High and Low Blood Glucose Fewer highs = less complications Alert Alert Alert Fewer lows = less accidents, coma, death •Medtronic 8 Diabetes
  • 9. Medtronic CareLink™ Personal Reports •Medtronic 9 Diabetes
  • 10. Safety and Comfort: Key Concepts for Success Most important for success. •Medtronic 10 Diabetes
  • 11. Step 1: Set Low Sensor Glucose Alert Low SG Alert ONLY High SG Alert is OFF 60 Alert sounds when Sensor Glucose is 60 mg/dl •Medtronic 11 Diabetes
  • 12. Step 2: Set High Sensor Glucose Alert Turn on High SG Alert 300 60 •Range between High and Low Alerts is WIDE. •Focus on safety, while learning how to understand CGM trends. •Medtronic 12 Diabetes
  • 13. Step 3: Tighten the Sensor Glucose Alerts Low SG Alert is 70 mg/dl High SG Alert is 250 mg/dl 250 70 • High and Low Sensor Glucose Alert thresholds are now closer to target range. • Adjust based on individual needs. •Medtronic 13 Diabetes
  • 14. Step #4: Add High and Low Predictive Alerts Predictive Alerts occur BEFORE the threshold. 250 70 • Optional Alert setting. 1:33P HIGH PREDICTED • Start with 10 minutes for Predictive Alerts, then adjust as needed. •Medtronic 14 Diabetes
  • 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. Next Step: Threshold Suspend Automation How 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. 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 Glucose Future Product Concepts Not approved in the U.S. 17 Management Diabetes
  • 18. And Around the World – What are we doing? Kazakhstan •Medtronic 18 Diabetes
  • 19. And Around the World – What are we doing? Haiti •Medtronic 19 Diabetes
  • 20. •Medtronic 20 Diabetes
  • 21. Conclusions Integrated Insulin Pump with Built-In CGM – Providing a wealth of data and personalized alerts and alarms can help you prevent dangerous highs and lows The 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 pancreas Advocating 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. Questions???? •Medtronic 22 Diabetes

Notas do Editor

  1. Benefit of pump + CGM (not just CGM)This is the foundation for an artificial pancreas
  2. 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)