MasterLab 2014 - July 2, 2014

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

•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

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

• 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

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.

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 http://www.cdc.gov/diabetes/statistics
2010
Diabetes, a Growing Epidemic
- 29 million people in the United States have diabetes, CDC 2
- estimated 86 million Americans

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.

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 http://www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_06.pdf
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%)

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…)

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

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

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

At this very moment, your
Congressperson is most probably
thinking about…
Re-election

About how many meetings will a
Congressperson have on the
average day?
23-30 meetings/day

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.

Congressional staff love to get…
One concise page
with local contact
information (e.g.
business card)
attached.

After you meet an elected official,
assume that the official visited…
Has forgotten that
you even exist.

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

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!

• 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

“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.

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?

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!

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
Stayce.beck@fda.hhs.gov

Agenda
• General introduction to FDA
• How does FDA regulate Glucose
Meters?
• Diabetes Diagnostic Devices: Where are
we now?

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

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

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.

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

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

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

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

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.

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

• 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

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

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!

Diabetes Diagnostic Devices:
Where are we now?

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

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

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: Regulations.gov
• 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

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?

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

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!

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

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
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guida
nceDocuments/UCM263366.pdf)
• Promises to be more convenient for patients

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

• 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

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)

EFFECTIVE PATIENT ADVOCACY
PRESENTED
BY MICHAEL MANGANIELLO
FOUNDING PARTNER, HCM STRATEGISTS

The Power Of Patients
Patient Driven CHANGE Is Possible

Back to Basics
ATTENTION
KNOWLEDGE & SOLUTIONS
COMMUNITY
ACCOUNTABILITY
LEADERSHIP

Key Accomplishments
Garnered Political Will to Support Federal
Investment in Research and Care
Parallel Track
Accelerated Approval

The Model Works
Across Diseases
Right?

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

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!

Duchenne Muscular Dystrophy
Sarepta Therapeutics - positive results in
clinical study of 12 boys
FDA expresses skepticism
Parents and families mount aggressive FDA
campaign

5 months later
FDA details a potential path forward for
the drug and indicated willingness to
consider it for accelerated approval

Thank You
Presented by: Michael Manganiello
Email: michael_manganiello@hcmstrategists.com
Phone: 202.547.2222
Link For Back to Basics:
http://hcmstrategists.com/wp-content/themes/hcmstrategists/docs/Back2Basics_HIV_AIDSAdvocacy.pdf

Understanding Diabetes: Knowledge and
Solutions
Kelly Close and Adam Brown
diaTribe (www.diaTribe.org)
Close Concerns (www.closeconcerns.com)
Diabetes Advocates’ Master Lab
CWD Friends for Life 2014

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

About Us: Kelly and Adam
Years we want to live:
LOTS!

About Us
“I founded Close
Concerns to make
everyone smarter
about diabetes
and obesity.”

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

ADA’s “Estimated Average Glucose”

“Translating the A1C Assay Into Estimated
Average Glucose Values” – Nathan et al., 2008
Source: Dr. David Nathan et al., Diabetes Care 2008

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

Example 1 – A1c of 7%
In-Range
63%
Hyperglycemia
29%
Hypoglycemia
8%

In-Range
18%
Hyperglycemia
58%
Hypoglycemia
24%

In-Range
100%

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?

Is the tide changing?

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!

We Need Therapies That Increase Time in Zone

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

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

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

Can type 1s benefit from type 2 drugs?
• Yes!
– Metformin
– GLP-1 agonists
– SGLT-2 inhibitors

Metformin for type 1 diabetes

GLP-1 Agonists for type 1 diabetes

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

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

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
Percentage
of
Patients
A1c under 7%
13% 13%
2003-2006 2007-2010
A1c over 9%
Less than 29% of
patients are on
insulin!

CGM for Type 2 Diabetes
Source: Vigersky et al., Diabetes Care, 2012

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

Artificial Pancreas for Type 2 Diabetes

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

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!

Example #1: JDRF – CGM and AP Guidance

Example #2: StripSafely

Example #3: Afrezza Open Public Hearing

Upcoming Advocacy Opportunities
Liraglutide 3.0 mg for Obesity
September 11, 2014
Washington, DC

AACE Advocacy Meeting
September 12, 2014
Washington, DC

AACE Consensus Conference on Blood Glucose
Monitoring
September 29, 2014
Washington, DC

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

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

Individualize therapy! There is no one-size-fits-
all approach… - www.diaTribe.org/patientguide

Avoid the Treat to Failure Model

Aim for better, faster, tighter feedback loops
Measure
Analyze
Make
Changes
Live
Happier/
Healthier
Life
Improve

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.

THANK YOU!
kelly.close@diaTribe.org
adam.brown@diaTribe.org
www.diaTribe.org
+1 415 241 9500

The Art and Power of Influence
One Advocate’s Advice
Rebecca Wilkes Killion

Patient History
• Adult Onset: 38 years old
• 1st Diagnosis: Type 2
• 2001: Near Fatal DKA
• 2nd Diagnosis: Type 1

FDA Patient Representative
• Appointed in 1999
• First Wave
• Member of the Endocrinologic and Metabolic
Drugs Advisory Committee
• First Meeting: Withdrawal of Troglitazone

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

“There is no such
thing as small
change.”
- Meri Schumacher

MasterLab 2014 - July 2, 2014

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MasterLab 2014 - July 2, 2014