Diabetes Technology in 2018 Irl B. Hirsch, MD University of Washington School of Medicine Seattle, WA
Dualities Research: Medtronic Diabetes Consulting: Abbott Diabetes Care, BD, Bigfoot, Roche
Let s First Discuss Home Blood Glucose Analysis 1922 1956
Downloading: 2018, Hybrid Closed Loop
Raise Your Hand If In Your Practice Every patient gets their meter downloaded Every patient gets their pump downloaded Every patient gets their CGM downloaded No patient gets downloaded, but you encourage your patients to download at home
What You Need (Minimal) A program which allows downloading of various meters/pumps/sensors Clinipro (Numedics.com), Glooko/Diasend, Carelink, Tidepool Ideally, many of the native softwares are also available A better solution: immediate upload to the cloud Livongo, Accucheck Aviva Connect, Dexcom Clarity Clarity Given all of the nuances we are appreciating with HbA1c, using TIRs from CGM is becoming a new standard
Here s Why: Average Glucose Versus A1C A1C (%) AG (mg/dl [95% CI]) 5 97 (76-120) 6 126 (100-152) 7 154 (123-185) 8 183 (147-217) 9 212 (170-249) 10 249 (192-282) 11 269 (217-314) 12 298 (240-347) One can t compare the A1C levels between 2 people! Nathan DM, Kuenen J, Borg R, Zheng H, Schoenfeld D, Heine RJ. Diabetes Care. 2008;31:1473-1478.
Diabetes Care 2017;40:994-999 Study 2: Mean CGM Glucose by HbA1c (N=208)
Hematologic conditions Anemia Accelerated erythrocyte turnover Thalassemia Sickle cell disease Reticulocytosis Hemolysis Physiologic States Aging Pregnancy Drugs/Medications Alcohol Opioids Vitamin C Vitamin E Aspirin Erythropoetin Dapsone Ribavirin What Alters A1C Disease States HIV infection Uremia Hyperbilirubinemia Dyslipidemia Cirrhosis Hypothyroidism* Medical Therapies Blood transfusion Hemodialysis Miscellaneous Glycation rate Protein turnover Race and ethnicity* Laboratory assay Glycemic Variability Smoking Mechanical heart valves? Exogenous testosterone? In a typical diabetes practice, 14%-25% of A1C measurements are misleading
International Consensus Panel Recommendations Self-evident glucose metrics for patients, clinicians, and researchers 5 thresholds TIR: 70-180 mg/dl (3.9-10.0 mmol/l) TBR: < 70 mg/dl (< 3.9 mmol/l)*; < 54 mg/dl (< 3.0 mmol/l)** TAR: > 180 mg/dl (> 10.0 mmol/l); > 250 mg/dl (> 13.9 mmol/l In addition to (or as opposed to) A1C, we can now compare studies to each other by comparing buckets and patients can now also be compared-not like A1C * alert hypoglycemia; ** severe hypoglycemia; Danne T, et al: Diabetes Care 2017;40:1631-40
HbA1c levels for a Given Time in Range (70-180 mg/dl) for an Individual with T1D Measured TIR Estimated HbA1c 95% CI 40% 8.1% 7.1-9.1% 50% 7.7% 6.6-8.7% 60% 7.2% 6.2-8.3% 70% 6.8% 5.8-7.8% 80% 6.4% 5.2-7.4% Beck R: ATTD, Vienna, 2018
Transitioning is Always Difficult For glycemic variability, it is time to transition away from SD and to CV For > 25 years: SD X 3 < mean (for means 120-180 mg/dl) has been our target Consensus: CV (SD/mean) a better metric CV target: 36? 33?
The Painful Reality: Few US Endocrinologists Routinely Look at Downloads Due to The Time Commitment and Overwhelming Data Presentation (What About in Australia?)
Advances in Home Blood Glucose Testing (it s not going away) Business model: meters and strips are provided for free (e.g., large company such as Boeing, Ford, Amazon, etc.) Glucose is uploaded to cloud immediately when tested Poor control can be intercepted early by company HCPs If critical BG tested, patient is called or texted immediately by Livongo CDE Waiting for studies showing overall reduced cost to system with this model
Available Now (but not yet in US) Mobile Application Insulin pen monitor Small BG meter, size of memory stick Audible activation Your office Glucome.com
https://www.diabetestechnology.org/surveillance.shtml Accessed April 20, 2018 N = 1035 for the latest ISO standard (ISO15197-2013)
What do we know about T1D and technology in the United States?
Based on 20 million commercial covered lives, an analysis conducted by Truven Health Analytics showed 66% of adults with type 1 diabetes were seen by primary care doctors
Original 67 Sites, T1D Exchange (2012)
CSII: What Does The Clinical Diabetologist Need To Know in 2018?
FEW What we can conclude 1. More connectivity with CGM 2. Can see closed loop systems in the notdistant future 3. Advantages vs. MDI not obvious with CGM use with more MDI patients, positive data with MDI/CGM (DIAMOND and GOLD) 4. My opinion: too many patients on CSII without adequate education to take advantage of the technology (with or without CGM)
Opinion: Bolus Calculators Are An Important and Under-Utilized Tool BUT, they are not smart! If the glucose is trending up or down, more or less insulin will be required Estimate Details: Bolus Calculator Est. total 4.5 U Food intake 36 g (meter) BG 210 Food 3 U Correction 2 U IOB 0.5 U
CASE 1: 20 y/o T1D, Down Syndrome T1D X 11 years, CSII and CGM. Last SH 5 years ago; HbA1c 7.6%
High basals in the evening do help to cushion dinner but usually result in hypoglycemia if not snacking. Timing of nocturnal basal change is important! Hypoglycemic seizure at 1:30am. Why?
What Happens When This Patient (now 21 years-old) Goes on a 670g? My opinion: for the right patient personality, they clearly improve diabetes control and quality-of-life There are certain patient personalities they don t work well-like everything there are pros and cons and while this is an advancement in our technology, it is a first (but important) step
Case 1: 15 months later
Case 1: HCL No sensors! Need more aggressive ICR?
Case 1: HCL
What I Did Shorter AITr More aggressive ICR
Problems in 2018 With our Technology Daily details on Carelink which allows us to understand if the bolus calculator is working correctly taken away from manual mode in 670g Smart Pens not yet widely available (hopefully soon) for MDI patients Solutions: use of other software
Case 2: Included With Infrastructure: Assessing The Data With Other Pump/CGM 38 y/o woman with T1D preparing for pregnancy Uses OmniPod and Libre (Libre started 12/17) BMI 30; on hypocaloric diet to lose weight A1C 11/17= 7.4% Details of boluses, over-rides, temp basals important but views from the sky can also be important
Libre AGP and glucometrics
Tidepool Carbs, amount suggested, amount delivered with Libre 1. Increase basal 10p-4a 2. Less aggressive carb ratio with more use of extended boluses with dinner
Sensors: Continual Evolution For the Near Future Guardian Sensor 3 Freestyle Libre Glysense Implantable Sensor Dexcom Gen 6 Sensionics Implantable Sensor
FreeStyle Libre All CGM systems have the same general accuracy in the 80-200 mg/dl range Libre has a higher MARD with blood glucose < 70 mg/dl (MARD 24%) (BMJ Open Diabetes Research and Care 2017;5:e000320. doi:10.1136/bmjdrc-2016-000320) Results can read low, meaning insulin-requiring patients may be tempted to treat perceived hypoglycemia when none is actually present The device gives an icon to measure blood glucose to mitigate this problem
64 y/o Lawyer with T2D History of RA and breast cancer, now not on steroids T2D X 10 years, recently moved to Seattle from SF area Receiving glipizide, metformin, and liraglultide When first seen placed Libre Pro on her. HbA1c at the time was 6.0%
March/April, 2017
March/April 2017 Glipizide stopped, blood sugars spiked into high 100s, started empagliflozin, later started Libre 12/17
March, 2018 Measured HbA1c = 6.5%
Why So Much Excitement in May, 2018? Dexcom G6 approval 3/28/18 in US (for June 2018 launch) Factory calibration, easier application, acetaminophen blocking, predictive low alert, extended 10 day sensor First icgm system icgm systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices (AIDs, apps, pumps, dosing algorithms) Lower regulatory burden (class II from class III which will allow quicker innovation)
Senseonics EverSense: FDA Advisory Committee Approval March 29, 2018 Implantable for 90 day wear, insertion takes less than 5 min 8.5% MARD, 2 fingerstick cals/day, adjunctive labeling at first (will require fingersticks for insulin dosing) Smartphone only display, no acetaminophen interference
Sensionics.com Florescence to transmitter
In the not-too-distant future: The Bigfoot ecosystem; pivotal trial in 2019
Summary Technology for diabetes control in 2018 is exploding It is difficult to keep up with everything CGM is only increasing in use, for both the very young and the elderly It is critical endocrinologists become comfortable with reading meter/pump/cgm downloads, especially since all HCPs now have access to data Like pumps, each CGM has its own nuances which need to be understood How this all will impact our administrative burden (in the US) in the next few years is not discussed by industry but is a huge concern of mine. How will this all play out in Australia?
A Final Thought About Technology From Seattle Most people overestimate what they can do in one year and underestimate what they can do in ten years. Bill Gates