Technology in Diabetes Management 2016 Irl B. Hirsch, MD University of Washington
Dualities Research: Helmsley Charitable Trust, JDRF, ADA, NIDDK, CDC Consulting: Abbott, Roche, Intarcia
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 If you have at least one computer designated for downloading If your downloads are uploaded into your EMR
Required (or at least desirable) Infrastructure for Your Office Person knowledgeable with insurance/payers, PAs, verbiage to efficiently gain approval Person (doesn t have to be CDE) who can train patients; pros and cons of using all industry support Coming soon? Kiosks in the waiting room for patients to download their own technology Mechanisms (stickers) to ensure technologies do not get mixed up Dedicated computer(s) for downloading
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
Metrics in Diabetes Meaningful Use (performance metrics) Glucometrics : analysis of blood glucose data To better understand the glycemic fingerprint of each individual patient: A1C, mean, SD, CV, TIR, LBGI What we always seem to be doing in diabetes: updating the metrics ( work in progress )
Standard Deviation Our clinically available measurement of glycemic variability for both SMBG and CGM Many other statistical analysis are available but correlation will be with CGM and outcomes, not SMBG (current studies using CV) Can determine both overall and time specific SD SMBG: Need sufficient data points Minimum 5 but prefer 10
Calculation To Determine SD Target SMBG SD X 3 < MEAN SD X 2 < mean, may be difficult for some type 1 patients. Formulas only relevant for mean BG between 120-180 CGM SD X 3 < MEAN Need better metrics: CV, TIR, TBR, TAR all to be correlated with outcomes
CASE 1: Christie 32 y/o woman on 8 units glargine BID with pre meal lispro 1:15, ISF 50 day, 60 at HS; jogs at 7am 5X s/week; b fast at 8a, lunch at 1p, dinner at 7p Mean/SD 126/47; A1C 6.0% 1. Too much basal Too much prandial with downward trend As is often the case, the A1C doesn t reflect all of the major challenges are patients are having Poor prandial replacement
CASE 2 45 y/o Ethiopean man moved to Seattle to work as an executive for a coffee company (we don t have Dunkin Donuts in Seattle) T2DM X 10 years, on insulin X8 years BMI 36; A1C 8.7% Has been on SAP for 4 years
SEPT 2014:MEAN 197; SD 75; A1C = 8.7%
Good basal BC: 17U BC: 11.5 U 60 g CHO 44 g CHO Stayed high: last bolus not enough No bolus: too much basal? Insulin given with food Insulin given with food
With All of This Technology, His Major Problem (or Should Be) is Easy to Fix Insulin needs to be given before one eats! Why is this so difficult for so many patients?
So What Happened To Our Patient s Diabetes Over the Next Two Years? OCT 2016: Mean = 156; SD = 41; A1C = 7.1%
CSII: What Does The Clinical Endocrinologist Need To Know in 2016?
Features of CSII: Evolution Over the Years Many basal (alternating, temp) and bolus (extended, 2 component) options but to me, the most important ones both grossly under utilized by patient and provider: Downloading both for patients and providers. Bolus calculator: when used appropriately is a tremendous tool!
The Problem with Bolus Calculators 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
Like With Pumps, We ve Come A Long Way With CGM
Sensors: Continual Evolution For the Near Future Guardian Sensor 3 Freestyle Libre Roche Glucose Sensor Dexcom Gen 6 Sensionics Implantable Sensor
Medtronic Sensors For the Next 5 Years
What is AP? CGM + Pump + Controller Controller: laptop, tablet, phone to start, chips will get smaller
Our Current Pathway to AP (Closed Loop)
Past, Present, and Future of CSII/AP CSII LGS and PGS Lancet Diabetes Endocrinology 2014; 2:701 709 SAP Nocturnal CL HCL LB 99 ADA, 2016
ARTIFICIAL PANCREAS
What is Hybrid Closed Loop? Patient still needs to bolus for meals and notify the system for exercise. Medtronic 670G approved for release in 2017
Medtronic 670G Pivotal Trial ADA Scientific Sessions 2016, Bergenstal, Buckingham, Garg et al: 99 LB Single arm, non randomized, 3 months N = 124 (n=94 adults, 30 adolescents) Baseline A1C 7.4%; mean reduction 0.5% Those with baseline > 7.5% reduction by 1.0% Time < 70 mg/dl reduced by 44%, < 50 mg/dl by 40% Time in range increased 72% 1.4 kg weight increase in adults, 1.0 kg weight gain in adolescents MARD 10.3%
All patients
Adolescents
More Information About the 670G No control group: an up coming 1000 patient trial is planned Two on going pediatric studies in 7 14 year olds and 2 6 year olds DreaMed MD Logic (Fuzzy Logic): incorporate automatic correction doses: bridge funding from NIH secured. This product will be called Medtronic 690G
IBM Watson (appears to be positioned more for non CL patients)
More To Think About with our First HCL Psycho social studies now on going: little now known how will this impact QOL for needing to unlearn behaviors (eg., hypo Rx with down arrow) Are expectations too high, especially for clinicians in non centers of excellence? What about type 1 patients not seen by endocrinologists. How will the elderly do with this technology?
Components of a Bi Hormonal AP (Bionic Pancreas) Are 2 hormones better than 1? Are we better off with glucagon, pramlintide, or GLP 1?
Finally: Some Data For What We ve All Been Wondering! N = 10; CL, then 4 weeks 60 mcg PRAM ac Mean age 20 years, 9 years T1D, A1C 7.2% N = 11: CL, then 4 weeks 1.8 mg daily LIRA Mean age 22 years, 10.5 years T1D, A1C 7.5% Meals were not announced Diabetes Care 2016;39:1127 1134
CL vs. CL + PRAM or LIRA Adjunctive Rx: Purple Control: Green Diabetes Care 2016;39:1127 1134
CL vs. CL + PRAM or LIRA CL vs. CL + PRAM CL vs. CL + LIRA 3.5 3.5 3 2.5 2 1.5 1 0.5 0 P<0.001 2.9 1.6 Time to Peak G (h) 3 2.5 2 1.5 1 0.5 0 P=NS 1.8 1.8 Time to peak G (h) CL alone CL + PRAM CL alone CL + LIRA CL vs. CL + PRAM CL vs. CL + LIRA 150 100 50 0 P<0.001 96 59 P=0.05 98 76 0 Glucose Spike Glucose spike CL CL + LIRA CL CL+PRAM 150 100 50 Diabetes Care 2016;39:1127 1134
CL vs. CL + PRAM or LIRA TIR during daytime better with PRAM (p<0.004) but not LIRA (p=ns). Neither drug with better TIR overnight LIRA: better weight loss (3.2 kg) compared to PRAM (0.7 kg) Longer term studies with these adjunctive agents are warranted. Diabetes Care 2016;39:1127 1134
But What About Glucagon? Would this be a better adjunctive hormone to infuse in a CL system?
Bihormonal AP 2014
ẞeta ẞionics 2016
Bionic Pancreas with 6 11 Year Old Children at Diabetes Camp Lancet Diabetes Endocrinol 2016;4:233 43
Mean CGM and Percentage <70 mg/dl Bionic Pancreas vs Usual Care (Adults) 159+30.4 <70 = 7.3% <60 = 3.7% 2016: stable liquid glucagon analogue: ZP4207 from Zealand Pharmaceuticals 133+13.4 <70 = 4.1% <60 = 1.5% Russell et al. New Engl J Med 2014; 371:313-325
This is All VERY Exciting, but What Does All of This Mean for the Endocrinologist in Practice? Non pediatric, non academic endocrinologists Few (less than 10%) do any pump/sensor downloading, so unable to really see patterns/understand the granularity how the patient is managing the diabetes For many (number now known) much if not most of the training, insulin adjustments, management done by industry or non physician (often CDE) Unfortunately, this is so time consuming and there is so much more pressure to be productive, it isn t time efficient for many of us to routinely manage these patients Few learn to be experts in this therapy in their training
My Questions Could a more automated pump system make the therapy simpler and more efficient so both clinical endocrinologists and non specialists can easily oversee closed loop systems with better A1C levels with less hypoglycemia? OR, will this create a greater clinical burden making this therapy an even greater hassle requiring more infrastructure than it does now? Raise your hand if you think the administrative burden managing this therapy from your offices and clinics will be MORE than it is now! Will payers want to pay for this if the cost is more than a pump and sensor alone? (BTW many Medicaid patients in WA state are now back on human insulin)
One Other Point In the US, about 30% of our type 1 patients use CSII (60% in the T1D Exchange) and most agree the majority of adult type 1 patients receive their care from a nonspecialist The majority of patients use MDI will this therapy increase CSII use for those who are cared for by both endocrinologists and non specialists? 2 studies at 2016 ADA: outcomes improved with CGM and MDI
What About the 70% of T1D Who Use MDI? Companion Medical InPen system Approved by FDA 8/16, to be launched 2017 Will track prandial insulin doses (cartridge pens) and send to paired app via Bluetooth App also includes a bolus calculator (with real time IOB)
What does it look like?
Conclusion We are at a crossroads in the evolution of our pumps and sensors. While the technology for a HCL may be available within the next year, a true CL hopefully will be close behind Still, there are many questions that need to be answered: 1 vs. 2 hormones, which 2 nd hormone and how would each do in a pump, site failures, skin problems, cost, work flow, psycho social issues, CGM accuracy, etc., etc, etc Still, these are better questions than we had 5 years ago