DIABETES TECHNOLOGY: WHERE ARE WE NOW AND WHERE ARE WE GOING? Presented by: Tom Brobson March 3 rd, 2018
Who is this guy? Accelerating Progress 1
Oh that guy! Accelerating Progress 2
STATE OF T1D CARE Technology of the Past 3
GLUCOSE MONITORING 4
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
Dexcom G5
Abbott FreeStyle Libre 14-day sensor Factory calibrated swipe
CGM Accuracy Over Time Abbott Libre (12.3%) Medtronic Enlite 3 (10.5%) Faccinetti A. Sensors 2016
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
Coming Soon: Dexcom G6 Sensor 10 Day Duration Sensor Acetaminophen Blocking Factory Calibrated 30% Thinner Wearable Simple, Push Button Sensor Applicator
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 18
Several Other Players Glysens Profusa Biorasis Capillary Biomedical GluSense
JDRF RESEARCH Better Outcomes in T1D Pregnancies 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 EASD conference, September 2017 Lancet 390, 2347-2359 (2017)
Real World Result! 21
Artificial Pancreas Enable more effective and improved glucose control with significantly less burden 22
Smart Pens HumaPen Memoir pen (Eli Lilly) Timesulin pen cap Echo pen (Novo Nordisk) InPen Esysta smart pen Decision Support Tools Apps to help with insulin dosing calculations, optimization of pump setting For both health care providers and patients
ARTIFICIAL PANCREAS A Decade of Progress in AP Systems Veo-worldwide 640G Australia, Denmark UK USA soon 24
Medtronic 670G Hybrid Closed-Loop World 1 st 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 basal rates 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) 25
PATHWAYS TO ARTIFICIAL PANCREAS SYSTEMS AP Systems are coming Commercialization MDT: Hybrid CL: 2017 Bigfoot Biomedical: Hybrid CL Type Zero: Hybrid CL Beta Bionics: Dual-hormone Inreda: Dual-hormone Tandem Insulet SAG Roche The Plan for a World without T1D 26
Trials this year! Accelerating Progress 27
Currently Available Pumps Mostly sensor augmented pumps Tandem Roche Medtronic Insulet OmniPod (Patch Pump)
THE FUTURE OF JDRF ARTIFICIAL PANCREAS Three Goals for AP Systems 29
ARTIFICIAL PANCREAS Enhancing Glucose Control Additional inputs Faster insulins & other drugs Advanced algorithms 30
ARTIFICIAL PANCREAS Reducing Burden Advanced infusion sets Extended wear Integrated CGM Increased automation Miniaturization 31
ARTIFICIAL PANCREAS Expanding Access and Adoption Targeted subpopulations Barriers to adoption Open-protocol AP systems 32
Accelerating Progress 33
Accelerating Progress 34
BUILDING OUT LANDSCAPE FOR 2ND & 3RD GENERATION AP SYSTEMS Reduce Burden: Smaller Form Factor, Longer Wear RECENTLY FUNDED Making 1 st Gen AP work Better Longer Wear Infusion Sets 2 nd Gen Smaller Systems Concentrated insulin, miniature pumps, single port CGM/Infusion set 3 rd 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)
ARTIFICIAL PANCREAS Paving the Way for Open-Protocol 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 37
THANK YOU! QUESTIONS? 38