Friday, November16, 2012 Palo Alto, CA

FDA Perspective: How Different Constituencies Can Work

Together Better

Alberto Gutierrez, Ph.D. Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health Food and Drug Administration

The 2012 DiabetesMine Innovation Summit

•  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

Diabetes

Medical Device Innovation Pathway 2.0

Shorten the time and cost to market for innovative (and other) medical devices

Transform how FDA and innovators work together

New FDA initiative for medical devices

Collaboration Phase Clinical Trials Phase Market Approval Application Process

FDA Conference Center IT Tools

Innovation Pathway 2.0

•  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

Blood Glucose Meters

•  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?

Continuous Glucose Monitors (CGMs)

•  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

Data management

•  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

Remote monitoring

•  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

Mobile Applications

•  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

Artificial Pancreas

•  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

Hospital Glucose Sensors

alberto.gutierrez@fda.hhs.gov

Thank you!