Diabetes Technology for the Endocrinologist, Irl B. Hirsch, MD University of Washington

Transcription

1 Diabetes Technology for the Endocrinologist, 2017 Irl B. Hirsch, MD University of Washington

2 Dualities Research: Helmsley Charitable Trust, JDRF, ADA, NIDDK, CDC Consulting: Abbott, Roche, Intarcia, Adocia, Valeritas, Big Foot

3 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

4 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

5 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

6 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, especially in an ACO environment: updating the metrics ( work in progress )

7 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 and new consensus using CV) Can determine both overall and time specific SD SMBG: I prefer a month of data for less potential bias/outliers CGM: 2 weeks is fine

8 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 CGM SD X 3 < MEAN Better metrics: CV, TIR, TBR, TAR all to be correlated with outcomes

9 But For Now: We Have to Download Mostly with Mean/SD

10 Example: Richard Read aggregate mean/sd

11 Example: Richard Read aggregate mean/sd Read frequency of testing

12 Example: Richard Read aggregate mean/sd Read frequency of testing Review time-specific means/sds?

13 Other Advances in Home Blood Glucose Testing 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

14 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

15 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

16 Prediction: CV Will Replace SD (for CGM) By Both Providers and Their Patients July, 2017: Dexcom Clarity introduced CV to their statistical home page Some understand SD, but how in the world to interpret CV? Recall: issue of glycemic variability is risk of added hypoglycemia, which brings us to

17 So What is the Goal CV? Diabetes Care 2017;40:832-38

18 ONE Reason Why Downloading Is So Important: Understanding the Mean and Estimated A1C 24 year-old woman, MDI, using Dexcom, 14 years T1D This patient s HbA1c is 8.2%. She has a glycation gap due to iron deficiency anemia

19 Hematologic conditions Anemia Accelerated erythrocyte 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 turnover Disease States HIV infection Uremia Hyperbilirubinemia Dyslipidemia Cirrhosis Hypothyroidism* Medical Therapies Blood transfusion Hemodialysis In a typical diabetes practice, 14%-25% of A1C measurements are Miscellaneous misleading Glycation rate Protein turnover Race and ethnicity* Laboratory assay Glycemic Variability Smoking Mechanical heart valves Exogenous testosterone?

20 But even with all of these limitations, HbA1c is actually a more crude test than this

21 Estimated Mean Glucose: Current Study vs. ADAG HbA1c Current Study N=598 (mg/dl) mean (95% CI) ADAG N= 507 (mg/dl) mean (95% CI) 6% 132 (93-171) 126 ( ) 7% 155 ( ) 154 ( ) 8% 178 ( ) 183 ( ) 9% 201 ( ) 212 ( ) 10% 224 ( ) 240 ( )

22 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

23 SEPT 2014:MEAN 197; SD 75; A1C = 8.7%

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25 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

26 With All of This Technology, His Major Problem is Easy (or Should Be) to Fix Insulin needs to be given before one eats! Why is this so difficult for so many patients?

27 So What Happened To Our Patient s Diabetes Over the Next Two Years? OCT 2016: Mean = 156; SD = 41; A1C = 7.1%

28 CSII: What Does The Clinical Endocrinologist Need To Know in 2017?

29 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!

30 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

31 Smart? Is There Any Reason To Care? Why We Should Be Excited About Smart (Pumps) Integrating pump with a sensor and a computer could potentially make the insulin delivery smarter

32 CASE 3: 20 y/o T1D, Down Syndrome T1D X 11 years, CSII and CGM. Last SH 5 years ago; HbA1c 7.6%

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34 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?

35 CASE 4-Other Downloading Options 44 y/o woman, T1D X 22 years, using Omnipod and Dexcom Frustrated with downloading choices Decided to try Tidepool (Tidepool.org) Last HbA1c 6.8%

36 Blip CGM SMBG Toggle cursor: 29 g carb, suggested bolus 2.4 u, delivered 1.7 u Ouch!

37 Case 8a: Twin Sister! Dexcom, No Pump Most variability after breakfast and bedtime Highest average after lunch

38 BAD DAY Move the cursor

39 GOOD DAY

40 CASE 5 60 y/o woman, 41 years T1D using Animas Vibe Past history significant for PDR s/p PRP, DAN with gastroparesis After many years of no diagnosis, found in 2010 to have stiffperson s syndrome HbA1c prior to SPS Dx usually in the 7-8% range, after Dx most in 9-11% range % of total daily insulin is basal insulin What s going on?

41 Case 5: AGP from 60 y/o Woman with SPS Feb 2016, HbA1c 10.1% h

42 CASE 5: The Answer to the Problem (but you need the download!) No bolus

43 Why Are We So Focused on CSII? The majority of type 1 s use MDI and this is still the gold standard for severely insulin deficient type 2 s

44 Important 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 by nonendocrinologists (one recent estimate was that 2/3 of T1D is only seen by primary care) The majority of patients use MDI-will closed loop systems increase CSII use for those who are cared for by both endocrinologists and non-specialists? DIAMOND and GOLD studies (JAMA, 2017): outcomes improved with CGM and MDI

45 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) Many other companies working on these bluetooth enabled insulin pens

46 What does it look like?

47 Wait a Minute! What about our growing number of patients who can t afford this technology, and in fact can t even afford their insulin?

48 NPH Insulin in y/o man who still had insulin lispro and a few CGMs from last year. Deductable is $4000 and can t afford list price of glargine (let alone degludec), so he simply used NPH instead. His A1C is 6.9% NPH isn t so bad if you know how to use it!

49 Conclusion Technology for MDI is finally improving Downloading should be part of the vital signs for every patient using a meter, pump, or sensor The downloading software is improving, is connected to the cloud, and should assist us in helping our patients How the endocrinologist can efficiently utilize all of this technology in our current system requires further research