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?
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