Flash Glucose Monitoring & Implantable Sensors Timothy Bailey, MD, FACE, CPI President & CEO, AMCR Institute Clinical Associate Professor, UCSD School of Medicine
Disclosures Research Support: Abbott, Ambra, Ascensia, BD, Boehringer Ingelheim, Calibra Medical, Companion Medical, Dance Biopharm, Dexcom, Eli Lilly, Glooko, Glysens, Kowa, Lexicon, MannKind, Medtronic, Novo Nordisk, sanofi, Senseonics, Taidoc, Versartis, Xeris Consulting Honoraria: Abbott, Astra Zeneca, Ascensia, BD, Calibra, Capillary Biomedical, Eli Lilly, Intarcia, Medtronic, Novo Nordisk, Sanofi Speaking Honoraria: Abbott, Eli Lilly, Medtronic, Novo Nordisk, Sanofi
Monitoring Matters There is benefit from CGM use for EVERYONE with diabetes The majority of patients (even with type 1 diabetes) do not use or have access to a CGM device Adherence and persistence of CGM remain poor Additional options may increase CGM use 3
CGM Improves A1c & Hypoglycemia Vigersky RA. J Diabetes Sci Technol 2015;9:320-330
DIAMOND trial RANDOMIZED CONTROL TRIAL, 6 MONTHS, 158 T1 ADULTS >25 years CGM MDI Time in range (70-180 mg/dl) 51% 45% Beck R.W. et al. JAMA. 2017;317(4):371-378. Beck R.W. et al. JAMA. 2017;317(4):371-378.
GOLD trial CROSSOVER RANDOMIZED CONTROL TRIAL, 6 MONTHS, 161 T1 ADULTS >18 years CGM MDI Time in range (70-180 mg/dl) 42% 39% Lind, M. et al. JAMA. 2017 ;317(4):379-387. Lind, M. et al. JAMA. 2017 ;317(4):379-387.
CGM Use- T1 Exchange Data
CGM Use in Mealtime Insulin Dosers 2.9MM 0.3 MM 10% T2 60% 2.6 MM 90% T1 40% Mealtime Insulin using patients CGM penetration 1. Based on internal analysis from BBC and SHA claims data
27% of Patients Discontinue CGM Use Within 1 Year Reason N=262 CGM not working properly / accurate enough 71% Problems with adhesive / insertion 61% Too expensive / not covered by insurance 58% Uncomfortable to wear 41% Using pump / don t want two sites on body 33% CGM too big 28% T1D Exchange; Why Do Some People with T1D Stop Using a Pump and CGM? 2016 Type 1 Diabetes (T1D) Exchange Registry (2016)
CGM System Wish List Longer sensor life Less frequent sensor insertions Current systems require 25 50 replacements/year No calibration Easy to wear and remove For physical activities or discretion Less Alarms More Alarms Cheaper
Flash Glucose Monitoring 10 day sensor No calibration No alarms Records data q 15 min (8hr) Scan to see glucose levels 8-hour look-back with graph First SMBG replacer
Flash vs CGM Feature FGM CGM Alarms - + Duration 10-14 days 7-10 days Calibration - + (G6 optional) Data Transfer Requires scan Passive Transmitter Memory 8 hours 3 hrs (G6) Cost $$ $$$
Flash Glucose Monitoring RCT s Author Population Design Outcomes Bolinder T1, A1c<7.5%, no HU n=241; 6 mos. (vs SMBG) 38% time <70 mg/dl (A1c no change) Reddy T1, Gold >=4 or severe hypo within 6 mos n=80; 8 wks. (vs G5 cgm) greater time <60 mg/dl & distress with G5 Haak T2 on MDI, A1c 7.5-12% n=224; 6 mos (vs SMBG) 43% time <70 mg/dl (A1c no change) Bolinder J. Lancet 2016; 388: 2254 2263. Reddy M. Diabet Med 2018; 35: 483 490. Haak T. Diabetes Ther 2017; 8: 573 586.
Monitoring Matters: Real World Data Type 1 Exchange Data; 2011 Data from >51 000 FSL readers. Dunn T et al. DTT 2017; 19(Suppl 1):A12
Intermittent Flasher 20 y/o young woman; Type 1 diabetes since age 8 months Medtronic pump for many years; Omnipod started 12/2015; MDI since mid-2016 Tresiba 25 qd (states takes most days) Humalog 20-30 u/d (forgets frequently) Other meds: Lithium, Lamictal, Gabapentin, Lorazepam A1c (seen 2x/yr or less- away at college) 7/13/2016-12.7% 11/20/2017-11.5% - started FGM 1/2018 5/21/2018 9.9% CGM (5/8-21/2018): mean=278 (SD=109); TIR=20% (>range 80%)
Flash Data
FGM User Data > 700K patients in OUS ~100k patients in US (in 5 months) 1 41% mealtime insulin using patients on FreeStyle Libre are T1 patients 2 1. Based on claims data analysis 2. Based on email survey data 18
Implantables in Medicine Cardiac Contraceptive Diabetes Endurity Pace Maker Reveal LINQ Nexplanon MiniMed Insulin Pump Intarcia medici Eversense CGM Copyright Senseonics 2018
20 The Eversense CGM System Sensor Fully implanted Small size Up to 90 days Smart Transmitter On-body vibe alerts Removable/Rechargeable Gentle adhesive Mobile App Real-time readings every 5 mins No extra receiver Trends, alerts w/ predictive alerts
21 Copyright Senseonics 2018 How it Works Sensor Powered by Transmitter Fluorescence with Glucose Binding
Sensor Insertion / Removal Procedure Sensor inserted/removed brief, office-based procedure Custom insertion tools Procedure: Skin disinfected and anesthetized Small incision in upper arm Blunt dissector creates subcutaneous pocket Sensor transferred to pocket Similar removal procedure
Readings Directly on Mobile Device ios and Android platforms Current glucose reading Trend arrow Trend graph High glucose alert (top red line) High glucose target level (top green line) Low glucose target level (bottom green line) Low glucose alert (bottom red line)
Pivotal Trial Programs PRECISE II Jul 2016 N=90 T1/T2 Blinded use 8 sites PRECISION Feb 2018 N=35 T1/T2 Unblinded use 3 sites Primary Outcome: Accuracy and safety of the Eversense system through 90 days.
PRECISE II: Demonstrated Accuracy of Eversense Software Version Mean Absolute Relative Difference (95% CI) Study SW 8.8% (8.3%, 9.4%) SW 602 8.5% (8.0%, 9.1%) Based on all evaluable data from all patients with at least one paired glucose reading between primary sensor and reference values
Accuracy Comparison with Other CGMs through Sensor Life Device Data Source Percent of System Readings Within 15/15% of Reference DAY 1 DAY 3-4 DAY 7 DAY 10 DAY 14 DAY 30 DAY 60 DAY 90 Eversense PRECISE II 77% -- -- -- -- 91% 87% 85% PRECISION 79% -- 86% -- 88% 88% 87% 84% Dexcom G5* -- 77% 89% 90% -- -- -- -- -- Medtronic Guardian (3)* -- 68% 87% 82% -- -- -- -- -- FreeStyle Libre* -- 76% 82% 85% 85% -- -- -- -- * Summary of Safety and Effectiveness Data (SSED) - Medical Device Databases - http://www.fda.gov Results based on calibration every 12 hours 26
Sensor Wear, HbA1c, and Hypoglycemia Outcomes In Recent Landmark RCTs Reduction in the amount of time in hypoglycemia ranged from 38% (IMPACT) to 46% (DIAMOND) 1. Lind M, Polonsky, W, Hirsch, I, et al. CGM vs Conventional Therapy for Glycemic Control in Adults w/ T1D Treated With MDI The GOLD Randomized Clinical Trial. JAMA. 2017;317(4):379-387. 2. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology & hypoglycaemia in T1D: a multicentre, non-masked, randomized controlled trial. Lancet 2016; 388: 2254 63 3. Beck R, Riddlesworth, T, Ruedy, K, et al. Effect of CGM on Glycemic Control in Adults with T1D Using Injections for Insulin Delivery: The DIAMOND Randomized Clinical Trial. JAMA. 2017;317(4):371-378. 4. Battelino T, Conget I, Olsen B, et al. The use and efficacy of CGM in T1D treated with insulin pump therapy: a randomised controlled trial. Diabetologia. 2012;55(12):3155-3162. doi:10.1007/s00125-012-2708-9
Real-world adherence data Repeat users sensor wear time from 1 st to 4 th sensor. Based on commercial end users in Europe 1. De Bock M, Cooper M, Retterath A, et al. Continuous Glucose Monitoring Adherence: Lessons From a Clinical Trial to Predict Outpatient Behavior. Journal of Diabetes Science and Technology. 2016;10(3):627-632. doi:10.1177/1932296816633484. 2. Data on file. Senseonics 2018.
PRECISE II: KM survival probability of 91% at Day 90 PRECISION: All sensors functioned 90 days Sensor Longevity Sensor Survival Probability PRECISE II Sensor Survival Probability PRECISION 1.0 1.0 0.8 0.8 0.6 0.6 0.4 0.4 0.2 0.2 0.0 0 30 60 90 0.0 0 30 60 90 Time since Implant (days) Time since Implant (days)
AMCR Institute Trial Participant It was especially important for me not to be seen as sickly or overly dependent on glucose testing during this time. 62 yo woman with Type 1 DM MDI Lantus and Novolog Accurate Convenient Discreet Was better able to manage her DM in a discreet manner A1c improved from 7.1 to 6.8% The experiences and testimonial are unique and individual to the speaker, and may not represent the same experiences, results or conclusions of other patients regarding the Eversense System. Neither the speaker nor Senseonics endorses or promotes any use of the Eversense System that is not consistent with the product labeling.
Glucose Monitoring Matters Summary More glucose monitoring can only impact health if patients wear and interact productively with sensors. Implantables and FGM are important additions to our toolbox that will enable more of our patients to embrace CGM and achieve better glycemic control.
Practical Pearls Glucose Monitoring Matters CGM is better than SMBG (if it is used) Choice of system mostly depends on individual preference Alarms appear to be more effective in reducing hypoglycemia Newer CGM s will enable more of our patients to safely achieve glycemic goals