Presented by: Tom Brobson

DIABETES TECHNOLOGY: WHERE ARE WE NOW AND WHERE ARE WE GOING?

March 3rd, 2018

Accelerating Progress 1

Who is this guy?

Accelerating Progress 2

Oh that guy!

Technology of the PastSTATE OF T1D CARE

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GLUCOSE MONITORING

Blood Glucose Meter Accuracy

17 meters: MARD=5.6%-20.8%9 with MARD >10%

Ekhlaspour et al, JDST 2017

Continuous Glucose Monitors

CGM system consists of a sensor, transmitter, and

receiver (mobile phone)

Measures glucose concentration in interstitial fluid

CGM Metrics

Overall Control

Mean Glucose

Time in range (70 – 180mg/dL)

Hyperglycemia

Hypoglycemia

Glycemic Variability

First Real-time CGM

GlucoWatch G2 Biographer

FDA approved for adults in 2001 and children 7-17 yrs old in 2002

Real-time CGMs circa 2008

Dexcom: SEVEN Sensor

(FDA approved for adults in 2006)

Medtronic: Guardian REAL-Time Sensor

(FDA approved for adults/children in 2005)

Abbott: FreeStyle Navigator

(FDA approved for adults in 2008)

Current CGM Sensors

Dexcom G5

Abbott Libre – Flash Glucose Monitor

Medtronic Enlite 3 and iPro2 (blinded only)

Coming soon in U.S.

Sensionics Eversense (available in Europe)

Dexcom G6

DexcomG5

Abbott

FreeStyle Libre

swipe14-day sensor

Factory calibrated

CGM Accuracy Over Time

Faccinetti A. Sensors 2016

Medtronic

Enlite 3

(10.5%)

Abbott

Libre

(12.3%)

Accuracy of CGM Sensors

MARD Within 20 mg/dL or 20%

Dexcom G5 9.0% 93%

Medtronic Enlite 3 10.6% 88%

Abbott Libre 12.3%* 84%

Eversense 8.8% 93%

Dexcom G6 8.1% 96%

MARD= Mean Absolute Relative Difference

*9.7% after first 12 hrs on day 1 through 10 days

Simple, Push Button Sensor

Applicator

10 Day Duration SensorAcetaminophen BlockingFactory Calibrated

30% Thinner

Wearable

Coming Soon: Dexcom G6 Sensor

The Eversense System

Sensor Smart Transmitter Mobile App

Sensor lasts up to

180 days

Removable and

rechargeable

On-body vibe alerts

Gentle-on-skin

adhesive

No extra device to carry

iOS and Android platform

Alarm settings & reports

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Several Other Players

Glysens

Profusa

Biorasis

Capillary Biomedical

GluSense

The CONCEPTT study shows that use of continuous glucose monitoring (CGM) during pregnancy improves health outcomes for both mothers and babies

Women with T1D who used a CGM experienced better glucose control, spending an extra 100 minutes per day with blood sugars in a healthy range

Their babies were more likely to be born with a healthy birthweight and less likely to have hypoglycemia post-partum or to require intensive care

Funded by JDRF, this study is the largest clinical trial conducted to date with pregnant women with T1D -- it included 325 women from 31 hospitals in seven countries over 5+ years

We hope the results will encourage the use of CGM in women with T1D, particularly during pregnancy

We also hope this multi-national clinical trial will lead to improved access to technologies and evolving standards of clinical care worldwide

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JDRF RESEARCH

Better Outcomes in T1D Pregnancies

EASD conference, September 2017Lancet 390, 2347-2359 (2017)

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Real World Result!

Artificial PancreasEnable more effective and improved glucose control

with significantly less burden

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Smart Pens HumaPen Memoir pen (Eli Lilly)

Timesulin pen cap

Echo pen (Novo Nordisk)

InPen

Esysta smart pen

Apps to help with insulin dosing calculations, optimization of pump setting

– For both health care providers and patients

Decision Support Tools

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ARTIFICIAL PANCREAS

A Decade of Progress in AP Systems

Veo-worldwide

640GAustralia, Denmark UK –

USA soon

Medtronic 670G – Hybrid Closed-Loop World 1st Hybrid Closed Loop AP System

Indications for 14+ years old

Pediatric study underway

Contra-indication: <7 year old, or <8 units of insulin/day

Hybrid closed loop = automated basalrates

Still need to bolus for meals

Take care with Intense exercise, corrections for Stress Response etc

Uses new Guardian CGM (AKA Enlite 3), 7 days use, 2 cals/day

BS Target is fixed at 120 or 150mg/dl

Does not include any “Share” type ability

Pricing comparable to 630G ($7-8,000)

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AP Systems are coming……CommercializationPATHWAYS TO ARTIFICIAL PANCREAS SYSTEMS

26The Plan for a World without T1D

• MDT: Hybrid CL: 2017

• Bigfoot Biomedical: Hybrid CL

• Type Zero: Hybrid CL

• Beta Bionics: Dual-hormone

• Inreda: Dual-hormone

• Tandem

• Insulet SAG

• Roche

Accelerating Progress 27

Trials this year!

Currently Available Pumps

Mostly sensor augmented pumps Tandem

Roche

Medtronic

Insulet OmniPod (Patch Pump)

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THE FUTURE OF JDRF ARTIFICIAL PANCREAS

Three Goals for AP Systems

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ARTIFICIAL PANCREAS

Enhancing Glucose Control

Additional inputs

Faster insulins& other drugs

Advanced algorithms

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ARTIFICIAL PANCREAS

Reducing Burden Advanced infusion sets

Extended wear Integrated CGM

Increased automation

Miniaturization

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ARTIFICIAL PANCREAS

Expanding Access and Adoption

Targeted subpopulations

Barriers to adoption

Open-protocol AP systems

Accelerating Progress 33

Accelerating Progress 34

Reduce Burden: Smaller Form Factor, Longer Wear

RECENTLY FUNDED

Making 1st Gen AP work Better

Longer Wear Infusion Sets

2nd Gen – Smaller Systems

Concentrated insulin, miniature pumps, single port CGM/Infusion set

3rd Gen – Near Full Automation

Fully Implantable systems may be a way to achieve near full automation & convenience

Novel pumps/catheters, catheter failure

BUILDING OUT LANDSCAPE FOR 2ND & 3RD GENERATION AP SYSTEMS

Reduce Burden: Smaller Form Factor, Longer Wear

RECENTLY FUNDED

Additional Signals for Gen 2-3 AP Identify other signals to inform AP algorithms

Detection of onset, type, and duration of exercise, stress, sleep

Reduce burden and improve outcomes

User Centric AP systems Encourage Industry to Innovate and develop smaller, more convenient

AP systems

e.g. Integrated CGM/Patch pump

e.g. Flexible, thin, bandage-like pump

e.g. Integrated sensing and infusion

e.g. Less invasive sensing (sinlge-port)

BUILDING OUT LANDSCAPE FOR 2ND & 3RD GENERATION AP SYSTEMS

JDRF launched a new initiative that will support the development of open-protocol systems enabling artificial pancreas (AP) technology

Funding via RFA

Working with key stakeholders to establish clear regulatory and legal frameworks

Initiative aims to advance AP technology and user friendliness and ensure its accessibility to a wider group of people with diabetes

Encouraging interoperability among diabetes devices

Harnessing the innovative spirit of the user-driven, do-it-yourself (DIY) community

Will enable users of AP devices to achieve better glucose outcomes with an improved experience, in a way that works best for them

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ARTIFICIAL PANCREAS

Paving the Way for Open-Protocol AP Systems

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THANK YOU! QUESTIONS?