MasterLab 2014 - July 2, 2014


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MasterLab 2014 - July 2, 2014

  1. 1. Helping Ourselves & Others We Love With Diabetes Adapted by Paul Madden Initially Developed by my Colleague, Friend, Tom Boyer, Leading Advocacy Expert, Director, State Government Affairs; NovoNordisk Advocacy
  2. 2. •To share: •some helpful information, •define the stakeholders, •raise some thoughts/questions for your discussion and consideration, •if needed, inflame your passions in advocacy to benefit people living with diabetes. Thoughts About My Presentation
  3. 3. Who amongst us … • Knows the name of the President, the VP • Knows the name of their Member of Congress and Senators • Has met with their Member of Congress to further a goal • Votes • Writes letters or email to elected officials • Or … has an opinion about anything If you answered yes to any of these questions then … YOU ARE AN ADVOCATE, THANK YOU! I assume you are all here because you believe there is much more that we have to do. We need more determined advocates who understand the challenges, are humble enough to develop the solutions together, and stay focused so we can all, YES ALL; Type 1, Type 2, Gestational, Type 3, Pre-Diabetes can lead healthier, more productive, happier lives! A Poll of the Room
  4. 4. • Stakeholders 1: People Living with Type 1, 2, and 3 diabetes, Gestational Diabetes. • Stakeholders 2: Governments, Businesses, Schools, Taxpayers (our acquaintances, our friends), etc… • Without being inclusive with Stakeholders 1 and 2 we will not secure the growing number of advocates needed to ensure that access to optimal health and life’s robust opportunities (no discrimination) are realized by people living with diabetes and at risk of developing diabetes. Stakeholders
  5. 5. Question; How Much Do I (YOU) Value Diabetes Health and the Health of My Country? They are connected. If you value: •optimal health, for you, your loved ones, friends, co-workers, •a productive country that supports its people with proper access to care •the long term reduction of manageable health care costs which are shared by all. Now let me share just a glimpse of DM in the US, what has occurred to date, what works and what doesn’t and how our focused efforts can build a bolder story of success for people living with diabetes for today and our many tomorrows.
  6. 6. Age-Adjusted Prevalence of Obesity and Diagnosed Diabetes Among U.S. Adults Aged 18 Years or older 1994 2000 No Data <4.5% 4.5-5.9% 6.0-7.4% 7.5-8.9% >9.0% Source: CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at 2010 Diabetes, a Growing Epidemic - 29 million people in the United States have diabetes, CDC 2 - estimated 86 million Americans
  7. 7. Costs of Diagnosed Diabetes $245 billion in 2012  1 in 10 health care dollars in the U.S. are spent directly on diabetes and its complications,  1 in 5 health care dollars in the U.S. goes to the care of people with diagnosed diabetes.  People with diabetes who do not have health insurance:  have 79% fewer physician office visits,*  are prescribed 68% fewer medications than people with insurance coverage*  have 55% more emergency department visits than people who have insurance* The U.S. and much of the world are in dire financial straits. Leaders must understand that balanced diabetes as well as delayed, prevented and screened earlier Type 2 diabetes increases productivity in all parts of life, improves the quality of life and significantly decreases health care costs. Money Talks.
  8. 8. Diabetes has the Largest % Increase in Cause of Death from 2010 to 2011 According to the CDC, among chronic diseases, diabetes saw the biggest increase in death rate from 2010 to 2011; rising 3.4%. In comparison, death rates from heart disease, cancer and stroke dropped. Source: Hoyert DL and Xu J. Deaths: Preliminary Data for 2011. National Vital Statistics Report. 61(6): October 10, 2012; To access the full National Vital Statistics Report, visit Top 10 Causes of Death in the U.S. (% change from 2010 to 2011) •Heart disease (-3%) •Cancer (-2.4%) •Chronic lower respiratory diseases (+1.2%) •Stroke (-3.1%) •Accidents or unintentional injuries (unchanged) •Alzheimer’s disease (-2%) •Diabetes (+3.4%) •Influenza and pneumonia (+4%) •Kidney-related diseases (-12.4%) •Suicide (-0.8%)
  9. 9. Diabetes; State & Federal How are we doing? • Spotty coverage of insulin pumps and continuous glucose monitoring by federal health and insurers • Glucose testing strips more often limited by Medicaid, Medicare and some private insurers. Insurers telling ill informed doctors what to prescribe. • 4 year delay in the CA Supreme Court hearing a discrimination case impacting school-children with diabetes • >27% of the Seniors have diabetes. Insulin Pumps and CGMs not specifically covered by Medicare. Often pay for just 2 blood strips per day. (This inadequate coverage suggests that our diabetes get easier to balance as we get older?? We wish this was true. Often >more hypoglycemic unawareness, greater risk of more serious complications of hypoglycemia…)
  10. 10. Diabetes Action Plan (Kentucky/Texas Model) Requires collaboration among several State Agencies to collaborate to identify goals and benchmarks while also developing individual entity plans to reduce the incidence of diabetes in Kentucky, improve diabetes care, and control complications associated with diabetes. Recent Challenges that became wins: Diabetes Special School, Sharps containers… Best Practice: Pass Targeted Legislation Other Diabetes Legislation:  Safety for Students with Diabetes (Georgia Model) With parental consent, grants students the autonomy to self-manage and self-treat their diabetes AND trains school personnel in diabetes care.  Covered Diabetes Benefits for State Medicaid Recipients Recommended covered benefits include: Mandatory screening for gestational diabetes, participation in NIH, evidence-based Diabetes Prevention Program “For the first time state agencies are talking about how we can collectively tackle the diabetes epidemic in Kentucky.” - Dr. Steve Davis, Director, KY Department of Public Health
  11. 11. Corporate Commitment to Access = •Social Responsibility, •Selling Products/Services AND YES We Need and Want Them to Sell Good Products! Right partnerships are the key to success
  12. 12. At this very moment, your Congressperson is thinking about… A. Whether the move to defeat the previous question will succeed and defeat the rule for today’s scheduled legislation. B. Today’s hometown news interview C. The needs of people with diabetes D. Re-election
  13. 13. At this very moment, your Congressperson is most probably thinking about… Re-election
  14. 14. About how many meetings will a Congressperson have on the average day? 23-30 meetings/day
  15. 15. If the Congressional staffer you meet is so young that you think he or she is cutting class… Deal with it. Congress is run by people a large number of people. Respect and work closely with them.
  16. 16. Congressional staff love to get… One concise page with local contact information (e.g. business card) attached.
  17. 17. After you meet an elected official, assume that the official visited… Has forgotten that you even exist.
  18. 18. If you follow-up, you’ll get what you want 90% of the time. • Make notes of requested information • Secure business cards for follow-up conversations • Do debrief as instructed • Send email thank yous • Reminder call/email after 30 days – • Outlook 90 day reminder • Find other people who can support you and bring the same issue up with the legislator Short Term Follow-up Long Term Follow- up
  19. 19. In Advocacy, Remember, At the End of the Day At the end of the day governments, businesses and the general public vote mainly with their wallets in mind; what supports a better standard of life, their life opportunities, and again their wallets. The productivity advantages of balanced, earlier diagnosed, and delayed and prevented diabetes must be stressed and captured in programs. Balanced diabetes and diabetes that is prevented or significantly delayed costs society 10X to 30X less than consistently unbalanced diabetes with serious complications. Your passion, ample knowledge on diabetes advocacy, your network all woven together will make a significant difference in life outcomes for all of us. Thank you!
  20. 20. • Commit to monitor for problems related to discrimination and health coverage for people with diabetes in your community, in your schools, at your business, on your daughter’s sports team? • Commit to responding to advocacy alerts generated by reputable organizations? • Commit to develop a strong Diabetes Advocacy presence in your community, in your state and/or on the Federal level? • Work with other diabetes advocates with humility. How You Can Help
  21. 21. “There are risks and costs to a program of action, but they are far less than the long-range costs of comfortable inaction.” -John F. Kennedy If you don’t stretch your limits, You set your limits.
  22. 22. No One Can Advocate Alone •What are YOU angry about relative to your diabetes or loved one’s diabetes? •Are you ready to you engage in the advocacy effort to help fight diabetes and improve the lives of people impacted by the diabetes of all types? •Are you ready to bring other friends and leaders along to join you?
  23. 23. WE NEED YOU!!! WE WANT YOU BECAUSE YOU ARE DETERMINED AND YOU CARE “There are only two ways to live your life. One is as though nothing is a miracle. The other is as though everything is a miracle. Albert Einstein. Let’s you and I make some miracles to benefit people with diabetes!
  24. 24. The Role of FDA in regulating Diabetes Devices and Advancing Safe Innovation in the Management of Diabetes Diabetes Advocacy MasterLab July 2, 2014 Stayce Beck, Ph.D., M.P.H. Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health/FDA
  25. 25. Agenda • General introduction to FDA • How does FDA regulate Glucose Meters? • Diabetes Diagnostic Devices: Where are we now?
  26. 26. Diabetes • People with diabetes face many challenges: – Immediate risks everyday due to potential for severe hypo- and hyperglycemia – Long-term heath risks due to glycemic variability and hyperglycemia • Quality of life challenges – The need for multiple devices (meters, pumps, insulin pens, lancets, etc…) – Pain at lancing and injection sites – Complicated drug dosing and nutrition decisions – Data overload can be frustrating (e.g., CGM data) • Needs: – Devices that improve lives without adding complexity – Simple, easy to interpret device data outputs – Easy to use, safe, and effective medical products
  27. 27. Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Veterinary Medicine Center for Biologic Evaluation and Research Center for Food Safety and Applied Nutrition Office of Regulatory Affairs FDA Center for Tobacco Protect and Promote Public Health
  28. 28. Who Are We? • Center for Devices and Radiological Health/ Office of In Vitro Diagnostics and Radiation (OIR) • Division of Chemistry and Toxicology Devices: Courtney Lias, Ph.D., Director • Diabetes Diagnostic Devices Branch: Stayce Beck, Branch Chief • 44 staff and managers in the Division • Approximately 40-45% of Division work is directly Diabetes-related – Blood Glucose Meters – Point-of-Care glucose analyzers – Central Laboratory analyzers – Blood gas analyzers – HbA1c tests – Continuous Glucose Monitoring Systems (CGMs) – Artificial Pancreas Systems • Other Divisions – insulin pumps (not CGM-enabled), insulin pens, lancets, etc.
  29. 29. Risk-Based Classification of IVDs: • The classification of an IVD is risk-based, and determined based upon the intended use of the device • The risk of an IVD is based on the consequences of a false result • Three Classification levels – Class I: common, low risk devices – Class II: more complex, moderate risk – Class III: most complex, high risk and novel intended uses
  30. 30. Premarket Notification: 510(k) • 510(k) submission required of most class II devices • Submission has 90 day review clock • FDA clearance based on “substantial equivalence” to legally marketed device (predicate device) • What substantial equivalence to predicate device means: – Similar intended use – Similar performance characteristics – Similar fundamental scientific technology • What substantial equivalence may not mean – Identical technology • Submissions may require clinical data • Summary of FDA’s review and basis for decision is posted on the FDA website
  31. 31. Premarket Application (PMA) • 180 day review clock • Demonstration of safety and effectiveness • Does not use predicates • Submissions often include clinical data • Pre-approval inspection performed • FDA may seek advisory panel decision prior to approval • Summary of Safety and Effectiveness Data (SSED) posted publicly on web
  32. 32. Premarket Review • Assessing Safety – Risk of misdiagnosis due to a false positive or false negative result – Assessing warnings against unsafe use • Demonstrating Effectiveness – Assessing device performance characteristics – Directions and conditions for use
  33. 33. Analytical Validity • Repeatability/Reproducibility – Will I get the same result in repeated tests over time? – Will I get the same result as someone else testing the same sample? • Accuracy – Will I get results that are the same as “Truth”? – “Truth” – may be a reference method, clinical endpoint, predicate device, etc.
  34. 34. Example: Blood Glucose Meter
  35. 35. Blood Glucose Meter: Analytical Performance • Precision • Measurement Range • Accuracy: Percent of Readings within 5, 10, 15 % of reference- example 95% w/in 15%, 100% w/in 20% • Interference • Hematocrit • Altitude • Temperature
  36. 36. • Clinical Validity – Device must have a clinical indication – Device should add value to clinical management • Clinical Validity claims may be based on: - Existing clinical data (i.e. no new clinical data needed) - New clinical trial data - Review of information in the literature - Current clinical knowledge Clinical Performance
  37. 37. Over the Counter IVDs for consumer use (OTC) have additional requirements: • Data submitted to demonstrate that the tests are accurate in the hands of lay users (including sample collection) • Studies are performed to evaluate how well lay users can understand the instructions without prompting, perform a self- test (or collect a sample), and obtain an accurate result • Lay users’ ability to understand the results of the test are also evaluated • Human factors are also considered in the review, where applicable
  38. 38. Medical Device Reports (MDRs) • Reports to FDA by user facility/manufacturer when a device: – Caused or contributed, or may have caused or may have contributed to a death – Caused or contributed, or may have caused or may have contributed to a serious injury – Malfunctioned or failed to meet specifications (manufacturer only): Recurrence could result in death or serious injury • Required timeframe for reporting – 5-30 days, depending on severity – Follow-ups when needed • FDA assesses reports and decides if action is needed • Anyone can report! We have a smart phone app!
  39. 39. Diabetes Diagnostic Devices: Where are we now?
  40. 40. Glucose Meters • Improvements in consumer features over the last few years • Improvements in interference detection • FDA published two draft blood glucose meter guidances in January 2014
  41. 41. Guidance Process: • Solicit input from Stakeholders • Use input to draft guidance • Release draft guidance to the public- not enforceable!!! • Solicit feedback from the community on the draft guidance with comments to the docket • Review the comments to the docket, revise the guidance accordingly • Discuss the feedback with stakeholders • Revise the guidance based on the feedback • Release final guidance to the public
  42. 42. Draft Glucose Meter Guidances • Increased Accuracy • Accuracy of meter on the outside of the box • Studies to make sure meter works in different environments • Draft documents can be found at: • We received over 600 comments, with over 200 from people with diabetes or their family members. We specifically asked that people comment on: • Things they didn’t like and suggestions of things that they would like to see along with their comment • If something wasn’t clear, so we could clarify it • Things they liked so we can have a balanced picture of feedback from all stakeholders
  43. 43. Post Market Safety • >25,000 Medical Device Reports/year for blood glucose meters • Variability in quality of reporting, decision-making at firms • Challenges: – High volume of data – Low quality data – Inconsistent compliance • Solutions – New methods for data analysis – Developing guidance for manufacturers • Clarify reporting criteria/methodology • Increase consistency across manufacturers – Potential new surveillance program?
  44. 44. Continuous Glucose Meters • CGMs are home use devices that continuously measure glucose in interstitial fluid • Have demonstrated benefit for the patients that use them • Recent Approvals – DexCom G4, down to 2 years of age! – Medtronic Enlite (part of 530G system) • Challenges remain: – Sensor accuracy needs improvement – New materials/technologies to reduce sensor biofouling needed – Improved reliability needed (e.g., signal dropout) – Better standards would help advance technology
  45. 45. Artificial Pancreas • Challenges: – Many still struggle to maintain good glycemic control – Hypoglycemic unaware individuals at risk – Risk of nighttime hypoglycemia – Better quality of life needed • The development of an Artificial Pancreas will improve outcomes for people with diabetes • Current challenges to get there: – Device limitations – pump imprecision, sensor inaccuracy/unreliability – Biology – complicated – Inter-individual variability – one size fits all possible? Smart algorithms? • Big developments are happening rapidly!
  46. 46. Artificial Pancreas • First step recently approved • Medtronic 530G Threshold Suspend System – 530G pump – Enlite CGM • In-clinic data submitted • Post Approval study: FDA requested Pediatric access in the Post Approval study
  47. 47. Mobile Applications • To facilitate new technologies, mobile platforms are key – Nearly everyone now carries a cell phone – Enable functions to allow for medical device interaction from that platform • Challenges include: – Security, hacking – specialized communication protocols essential – Android vs. Apple OS – Mechanisms for verification of software/OS updates and upgrades • FDA: – Is working closely with industry on requirements/process for market entry, upgrades, etc. – need to reach the right regulatory touch – Has already cleared/approved many apps in for use with diabetes devices – Published final guidance on Mobile medical Apps – provides more clarity and transparency ( nceDocuments/UCM263366.pdf) • Promises to be more convenient for patients
  48. 48. New Technologies Needed Quality of Life Improvements: • Consolidation of devices (meters, pumps, lancets, cell phones, etc.) • Easy data interpretation, standard data format and metrics • Consolidation of software/applications • Remote upload/data access capabilities (cloud computing) • Easier/faster download capabilities • Improved patient interaction with healthcare professionals
  49. 49. • Efforts to better reach Patients • FDA is trying to find ways to increase input from patients so that we can do a better job of taking the patient perspective when making premarket and postmarket decision. • The patient portal is an attempt to create better communication with the community • We get a lot of perspective from working with patients: • Face to face discussions • Conferences • Working with investigators and their patients, etc. • Grassroots efforts (e.g., #StripSafely campaign): Good Communication is key! Patient Interaction
  50. 50. What Can You Do? • Report adverse events (to the manufacturer and the FDA) • Comment to the Docket for the draft guidances • Become informed on the facts (from all perspectives)
  51. 51. Questions? Thank you!
  53. 53. The Power Of Patients Patient Driven CHANGE Is Possible
  55. 55. Key Accomplishments Garnered Political Will to Support Federal Investment in Research and Care Parallel Track Accelerated Approval
  56. 56. The Model Works Across Diseases Right?
  57. 57. Cystic Fibrosis Foundation
  58. 58. Kalydeco CF trial showed the drug could improve lung function for a small segment of the CF population (4% or 1,200 kids) with a specific genetic mutation From CFF’s perspective – 10% improved lung function for 4% was very significant Developed a strategy to have FDA recognize the benefit for this community
  59. 59. 2012 The effort worked. FDA Approved Kalydeco 3 months after it was submitted for review FDA EVENTUALLY Understood What Patients KNEW from the START There Was Significant Benefit!
  60. 60. Duchenne Muscular Dystrophy
  61. 61. Duchenne Muscular Dystrophy Sarepta Therapeutics - positive results in clinical study of 12 boys FDA expresses skepticism Parents and families mount aggressive FDA campaign
  62. 62. 5 months later FDA details a potential path forward for the drug and indicated willingness to consider it for accelerated approval
  64. 64. Thank You Presented by: Michael Manganiello Email: Phone: 202.547.2222 Link For Back to Basics:
  65. 65. Any First Timers?
  66. 66. I.O.U. Pay it forward.
  67. 67. YOU Pay it forward.
  69. 69. Slide 108 Understanding Diabetes: Knowledge and Solutions Kelly Close and Adam Brown diaTribe ( Close Concerns ( Diabetes Advocates’ Master Lab CWD Friends for Life 2014
  70. 70. Slide 109 About Us: Kelly and Adam years with diabetes: 38 years on a pump: 29 years on CGM: 10 infusion sets changed: 3,528 test strips used: 69,350
  71. 71. Slide 110 About Us: Kelly and Adam Years we want to live: LOTS!
  72. 72. Slide 111 About Us “I founded Close Concerns to make everyone smarter about diabetes and obesity.”
  73. 73. Slide 112 Outline • What is A1c not telling us? – Why a 7% ≠ 7%! • Bridging the Gap – Type 1 AND Type 2 Diabetes • Advocacy – Successful Examples and Upcoming Opportunities
  74. 74. Slide 113 Outline • What is A1c not telling us? – Why a 7% ≠ 7%! • Bridging the Gap – Type 1 AND Type 2 Diabetes • Advocacy – Successful Examples and Upcoming Opportunities
  75. 75. Slide 114 ADA’s “Estimated Average Glucose”
  76. 76. Slide 115 “Translating the A1C Assay Into Estimated Average Glucose Values” – Nathan et al., 2008 Source: Dr. David Nathan et al., Diabetes Care 2008
  77. 77. Slide 116 A1c does not tell the full story! An A1c of 7% = average blood glucose of 154 mg/dl Range Example 1 < 70 mg/dl 8% 70-180 mg/dl 63% > 180 mg/dl 29% Approximate A1c 7.0% Example 2 24% 18% 58% 7.0% Example 3 - 100% - 7.0% But time in range – and thus ‘quality of A1c’ – can be dramatically different! Source: Dr. David Nathan et al., Diabetes Care 2008
  78. 78. Slide 117 Example 1 – A1c of 7% In-Range 63% Hyperglycemia 29% Hypoglycemia 8%
  79. 79. Slide 118 Example 2 – A1c of 7% In-Range 18% Hyperglycemia 58% Hypoglycemia 24%
  80. 80. Slide 119 Example 3 – A1c of 7% In-Range 100%
  81. 81. Slide 120 FDA’s 2008 Draft Guidance on Diabetes Drug Development • “For the purposes of drug approval and labeling, the final demonstration of efficacy should be based on reduction in A1c, which will support an indication of glycemic control.” – But what about: • Hypoglycemia? • Weight? • Ease of use? • Taking less insulin? • And scads of other things?
  82. 82. Slide 121 Is the tide changing?
  83. 83. Slide 122 Is the tide changing?
  84. 84. Slide 123 But there is more work to be done! • Afrezza label does not mention the hypoglycemia or weight benefits in type 1 diabetes • CGM is still rarely used in drug trials • Industry may not take time-in-range seriously until it’s incorporated/emphasized in FDA drug guidance • Payers need to understand the patient perspective – A1c is not everything!
  85. 85. Slide 124 We Need Therapies That Increase Time in Zone
  86. 86. Slide 125 Outline • What is A1c not telling us? – Why a 7% ≠ 7%! • Bridging the Gap – Type 1 AND Type 2 Diabetes • Advocacy – Successful Examples and Upcoming Opportunities
  87. 87. Slide 126 Common conceptions about the different types of diabetes Type 1 • No insulin production • Often insulin sensitive • Younger • Thin • Genetic • Treatment: insulin Type 2 • Some insulin production • Insulin resistance • Older • Obesity • Lifestyle • Treatments: diet, exercise, pills
  88. 88. Slide 127 But there are so many commonalities...! Diabetes • Problems with glucose & insulin metabolism • Absence/presence of insulin production • Glucagon dysregulated • Insulin resistance • Glycemic variability • Genetics • Lifestyle • Drugs • Glucose monitoring • Hypoglycemia • Complications • Stigma/Burden/Stress • Impact on family Type 1 Type 2
  89. 89. Slide 128 Implications of this dichotomy “We have an uphill battle to reeducate people. Many think that type 1 diabetes is insulin-only, and these drugs are for type 2s only. I think we have to figure out how to get ADA, JDRF, ad agencies, and the Helmsley Charitable Trust funding some of this. It’s now coming together – people with type 1 may benefit from type 2 drugs, and people with type 2 should start insulin earlier.” – Dana Ball, Co-Founder, T1D Exchange; former Director, Helmsley Charitable Trust’s T1D Program
  90. 90. Slide 129 Can type 1s benefit from type 2 drugs? • Yes! – Metformin – GLP-1 agonists – SGLT-2 inhibitors
  91. 91. Slide 130 Metformin for type 1 diabetes
  92. 92. Slide 131 GLP-1 Agonists for type 1 diabetes
  93. 93. Slide 132 SGLT-1/2 inhibitor data in Type 1 • Lexicon’s LX4211 reduced bolus insulin by 32% over 4 weeks • Reduced A1c by 0.55% • Less hyperglycemia (CGM > 180 mg/dl): from 36% to 25% • More time in range (70-180mg/dl): from 56% to 68% • No extra hypoglycemia • Less glycemic variability by multiple measures • Weight reduction of 1.7 kg Phase 3 planning ongoing for type 1 diabetes; awaiting phase 3 partnership for type 2 diabetes
  94. 94. Slide 133 Can type 2s benefit from type 1 treatment approaches? • Yes! – Earlier, more frequent use of insulin – Treat to success – Therapeutic targeting using CGM – More convenient insulin delivery – Maybe even automated insulin delivery
  95. 95. Slide 134 Earlier, more frequent use of insulin in type 2 diabetes Source: Ali et al., NEJM 2013 57% 52% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2003-2006 2007-2010 PercentageofPatients A1c under 7% 13% 13% 2003-2006 2007-2010 A1c over 9% Less than 29% of patients are on insulin!
  96. 96. Slide 135 CGM for Type 2 Diabetes Source: Vigersky et al., Diabetes Care, 2012
  97. 97. Slide 136 Insulin Pump Therapy for Type 2 Diabetes Medtronic’s OpT2mise trial – pumps vs. MDI in T2D • Better A1c reduction: -1.1% (pumps) vs. -0.4% (MDI) • Less insulin: 20% lower daily dose with pump therapy • No severe hypoglycemia, no difference in weight gain
  98. 98. Slide 137 Artificial Pancreas for Type 2 Diabetes
  99. 99. Slide 138 Other Mutually Beneficial Areas • Biological research into causes and mechanisms of diabetes – Beta/alpha cell function – Insulin resistance – Diet – Genetics/Environment • Complications research and therapies • Research/therapies for reducing glycemic variability and hypoglycemia • Diabetes-friendly changes to the food environment, city designs
  100. 100. Slide 139 Key Takeaway Advances in type 2 diabetes benefit those with type 1 diabetes. Advances in type 1 diabetes benefit those with type 2 diabetes. We are all on the same team: Better lives for people with diabetes!
  101. 101. Slide 140 Outline • What is A1c not telling us? – Why a 7% ≠ 7%! • Bridging the Gap – Type 1 AND Type 2 Diabetes • Advocacy – Successful Examples and Upcoming Opportunities
  102. 102. Slide 141 Example #1: JDRF – CGM and AP Guidance
  103. 103. Slide 142 Example #2: StripSafely
  104. 104. Slide 143 Example #3: Afrezza Open Public Hearing
  105. 105. Slide 144 Upcoming Advocacy Opportunities Liraglutide 3.0 mg for Obesity September 11, 2014 Washington, DC
  106. 106. Slide 145 Upcoming Advocacy Opportunities AACE Advocacy Meeting September 12, 2014 Washington, DC
  107. 107. Slide 146 Upcoming Advocacy Opportunities AACE Consensus Conference on Blood Glucose Monitoring September 29, 2014 Washington, DC
  108. 108. Slide 147 Upcoming Advocacy Opportunities FDA Virtual Town Hall Meeting on Diabetes November 3, 2014 • “Our goal for this meeting is both to inform the diabetes community of what is already being done as well as hear from them about the issues we have yet to address.” • Drug + Device Divisions will jointly participate
  109. 109. Slide 148 Advocating with our healthcare providers as well! • Personal responsibility for us and … • Advocating responsibility for HCPs • Avoiding the treat to failure model • Individualizing therapy • Better feedback loops
  110. 110. Slide 149 Individualize therapy! There is no one-size-fits- all approach… -
  111. 111. Slide 150 Avoid the Treat to Failure Model
  112. 112. Slide 151 Aim for better, faster, tighter feedback loops Measure Analyze Make Changes Live Happier/ Healthier Life Improve
  113. 113. Slide 152 Concluding Thoughts • A1c is not everything – 7% is not the same as 7% • There many similarities between T1D and T2D – advances in each benefit the other • Many upcoming opportunities for advocacy with the FDA, professional organizations, and with our own healthcare providers • The voice of the patient must always stay at the center of therapy development, approval, and reimbursement.
  114. 114. Slide 153 THANK YOU! +1 415 241 9500
  115. 115. The Art and Power of Influence One Advocate’s Advice Rebecca Wilkes Killion
  116. 116. Patient History • Adult Onset: 38 years old • 1st Diagnosis: Type 2 • 2001: Near Fatal DKA • 2nd Diagnosis: Type 1
  117. 117. FDA Patient Representative • Appointed in 1999 • First Wave • Member of the Endocrinologic and Metabolic Drugs Advisory Committee • First Meeting: Withdrawal of Troglitazone
  118. 118. Epiphany
  119. 119. 5 Tips for Making an Impact 1. Membership Has its Privileges 2. Stand in Your Own Truth 3. Cut to the Chase 4. Visual Aids 5. Own Your Space
  120. 120. 783% increase
  121. 121. 783% increase
  122. 122. 783% increase
  123. 123. 783% increase
  124. 124. “There is no such thing as small change.” - Meri Schumacher