The document summarizes the history of glucose testing from ancient times to modern flash glucose monitoring systems like the FreeStyle Libre. It traces the evolution from urine and blood testing using chemical reactions to today's enzyme-based biosensors and continuous glucose monitors. The FreeStyle Libre is highlighted as a breakthrough that eliminates finger pricks, provides accurate readings with a 1-second scan, and addresses the need for more frequent glucose data through its 14-day sensor wear and Ambulatory Glucose Profile reports. Clinical trials aim to demonstrate its benefits in improving outcomes and gaining insurance reimbursement.

1. Revolutionising Glucose
Testing
JOURNEYS OF HEALTH TECH INNOVATION: PRODUCT TO MARKET
30 | November | 2015
Chris Thomas, Ph.D.
Ollie Mitchell
Marketing Director

2. Changes to glucose testing over the decades
Urinary Glucose Testing
• 1500 BC Egyptians first to mention
diabetes.
– Tested in medieval times by
appearance, taste
• 1838 George Rees, Guy’s Hospital
isolated glucose as sugar responsible
• 1945 Clinitest (Ames)
Blood Glucose Testing
• 1957 Dextrostrips – Clinitest
chemistry on 50-100 uL of blood
• 1970 – First benchtop meter,
reflectance based
• 1980 – First home meter:
Dextrometer and Ames Glucometer
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3. Changes to glucose testing over the decades
Biosensors (Enzyme Based)
• 1987 ExacTech (MediSense,
Cranford and Oxford Universities)
– 1991-2000 – smaller meters
• 1999 Cygnus Glucowatch
Biographer
– 2006 DexCom
– 2008 Abbott FreeStyle Navigator
– Medtronic
• 2014 Abbott Flash Glucose
Monitoring System
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4. Unmet needs in glucose testing
Current methods have significant issues
• Traditional Blood Glucose Monitoring (BGM)
– Current standard, widely available
– Pain, hassle and inconvenience of fingersticks
limits data points
– Overnight data is impractical
• Continuous Glucose Monitoring (CGM)
– Addresses data density issue
– Globally, <4% of glucose monitoring category due
to cost and lack of reimbursement
– Data interpretation challenges
• An alternative to both BGM and CGM for a
broad population was needed
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Liberation from the hassles of glucose monitoring
• No more routine finger pricks*
• Painless, 1-second scan
• Discreet – Anytime, anywhere even through
clothing**
• Accurate over 14 days
• No finger prick calibrations
• Designed to replace BGM – Use for day-to-day
therapy decisions
* A finger prick test using a blood glucose meter is required during times of rapidly changing
glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose
levels or if hypoglycaemia or impending hypoglycaemia is reported by the System or when
symptoms do not match the System readings.
** The reader can capture data from the sensor when it is within 1 cm to 4 cm of the sensor.

5. The FreeStyle Libre Sensor
• Small size (35mm x 5mm)
• Wear for up to 14 days
• No finger prick calibrations
• Water resistant* – swim, shower and
exercise
• Most agree it is painless to apply and
wear**
• Automatically measures, captures, and
stores readings day and night
• Fully disposable
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*Sensor is water-resistant in up to 1 metre (3 feet) of water. Do not immerse longer than 30 minutes.
** Data on file, Abbott Diabetes Care
Sensor is approximately the size of a 2 Euro coin

6. Addressing the data density issue with
Ambulatory Glucose Profile (AGP)
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7. FreeStyle Libre Flash Glucose Monitoring Summary
• Painless, 1-second scan of the reader over the sensor to collect glucose data
• 14 day sensor wear, fully disposable, small, low profile sensor
• Factory calibrated so no finger prick calibrations required
• Accurate, stable and consistent performance over 14 days – 11.4% MARD
• AGP-based reports to visualize comprehensive glucose data
• On-going RCTs focus on reimbursement through improved outcomes with the
use of FreeStyle Libre
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8. Our Journey
Pivot to strips
• 1997 TheraSense founded to
commercialise sensor technology
– Ca. $120MM venture capital
• 1999 Pivoted to strips to enable
earlier revenue stream
• 2001 Went public
– Supported sales force necessary to
compete in strip market
• 2004 Bought by Abbott to form
Abbott Diabetes Care, $1.2 Billion
– Two strip platforms, FreeStyle and
Precision
Reemergence of sensor portfolio
• Ca. 2008 narrowed focus to insulin
dependent diabetics (T1 and T2)
– Price pressure in strips, low cost
competitors
• 2009 withdrew Navigator from US
market
– Inclusion of 510k product in PMA
increases regulatory challenges in
510k products.
• As a result, started FreeStyle Libre
program to replace strip testing for
our target population
• 2014 – CE mark for FreeStyle Libre 8