1. FDA Perspective: How Different
Constituencies Can Work
Together Better
The 2012 DiabetesMine Innovation Summit
Friday, November16, 2012
Palo Alto, CA
Alberto Gutierrez, Ph.D.
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Food and Drug Administration
2. Diabetes
• More than 18 million children and adults in the U.S. have
been diagnosed with diabetes
• Diabetes healthcare costs in the U.S. surpass $170 billion
dollars
• Better management of this disease leads to improved
outcomes for patients
• Novel therapies and technologies promise to help patients
better manage their disease and improve the quality of their
lives
3. Medical Device Innovation Pathway 2.0
New FDA initiative for medical devices
Shorten the time and cost to market for innovative
(and other) medical devices
Transform how FDA and innovators work together
5. Blood Glucose Meters
• Current accuracy standard (+/-20%) criticized as too broad
• Call for tighter accuracy standards for meters used
in healthcare facilities and at home
• FDA held a Public meeting in March 2010 – input gained from clinical
community and patients
• FDA working on new guidance / standards to achieve:
• Clinically appropriate (yet achievable) accuracy standards
• Study designs that better reflect actual use
• Labeling and human factors improvements
Goal: Safer, more accurate devices for patients with continued
availability to for home and clinical use
6. Continuous Glucose Monitors (CGMs)
• CGMs are home use devices that continuously measure glucose in interstitial
fluid
• Have demonstrated benefit for the patients that use them
• Challenges remain:
• Sensor accuracy
• Sensor Biofouling
• Differences between interstitial fluid and blood glucose concentrations
• Signal dropout
• FDA has reached out to Industry to discuss ways to improve sensor technology
• Multiple new generation sensors in development by industry – promise to
provide incremental improvements in performance over the next several years
• Future – replacement of blood monitoring?
7. Data management
• Current efforts in glucose/insulin data standards development
• Needs:
• Easy data interpretation/standard data format and metrics
(esp. for CGM data)
• Consolidation of software/applications
• Easier/faster download capabilities – improved patient interaction with
healthcare professionals
• IDC/Helmsley Trust study
• FDA supports standardization efforts in this area - Promises to lead to better
patient experience
8. Remote monitoring
• Glucose meter and CGM device accessories for remote monitoring being
developed
• Touted for nighttime monitoring (e.g., for pediatric patients)
• Cloud-based monitoring
• Tele-medicine
• Data security/reliability are essential
• Promise as a safety tool to enable faster clinical studies, faster introduction of
innovative devices to market
9. Mobile Applications
• Movement toward consolidation of patient devices/interfaces (e.g., CGM, cell
phone, glucose meter, insulin pump)
• Security, hacking – specialized communication protocols
essential
• Android vs. Apple OS
• FDA is working with industry on requirements/process
for market entry, upgrades, etc.
• Promises to be more convenient for patients
10. Artificial Pancreas
• Development of an Artificial Pancreas will improve outcomes for people with
diabetes
• FDA changes/updates
• Now reviewed in the Office of In Vitro Diagnostics
• Consolidation of review team – efficiency of review process
• Continued focus on interaction with investigators, promotion of new
devices and studies
• Artificial Pancreas Guidance
• Drafts published June and December 2011
• Currently being finalized for publication soon
• Outpatient studies beginning for closed loop devices
• Feedback and ideas are welcome
11. Hospital Glucose Sensors
• Intended to be used in ICU settings for continuous or near-continuous
measurement of glucose to aid in glycemic control protocols
• Multiple products in development
• Venous or arterial blood
• Interstitial fluid
• FDA Public Meeting – June 25, 2012
• Value in trends
• Discussion on dosing/safety
• Study design considerations
• Broader use than diabetes, but novel technologies that result promise to advance
glucose monitoring devices
