Using and Interpreting Diabetes Data. Irl B. Hirsch, MD University of Washington

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1 Using and Interpreting Diabetes Data Irl B. Hirsch, MD University of Washington

2 Dualities Research: Helmsely Charitable Trust, ADA, JDRF, NIDDK Consulting: Abbott Diabetes Care, Roche, Intarcia, Valeritas, Adocia, Big Foot And if you still don t trust me I will be happy to share my tax forms with you

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

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 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

5 Glucometrics Analysis of blood glucose data To better understand the glycemic fingerprint of each individual patient: A1C, mean, SD, CV, TIR, LBGI

6 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

7 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

8 Example: Patrick Read aggregate mean/sd Note frequency of testing Note time-specific mean/sd

https://www.diabetestechnology.org/surveillance.

9 Accessed August 18, 2017 N = 1035 for the latest ISO standard (ISO )

12 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

13 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?

14 CASE 2 45 y/o Ethiopian 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

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

16 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

17 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?

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

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

21 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?

22 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%

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

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

25 BAD DAY Move the cursor

26 GOOD DAY

27 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?

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

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

30 Case 6 : 59 y/o Man, CSII Without CGM T1D x 21 years, CSII X 10 years, last seen by an endocrinologist more than 15 years ago Referred by concerned family member due to firstever severe hypoglycemia No interest in CGM HbA1c ranges 8 to 9.2%, most recent 8.5% First visit: 2-3 tests per day, mean/sd 202/85 Where to start?

of bolus calculator, asymptomatic hypoglycemia. Where to start?

31 Type 1 Diabetes, August, 2017: Where to Start? Only checking 2, at most 3X s per day, blind boluses, minimal use of bolus calculator, asymptomatic hypoglycemia. Where to start? WHAT I DID: BRING IN WIFE, ENCOURAGE CGM OR AT LEAST MORE FREQUENT SMBG, LOOK AT INSULIN DOSES!

32 Part of the Problem Too many basal doses, and they don t make any sense! Total basal is 27% of total daily insulin dose with losest dose between 9am to 3:30pm

33 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

34 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

35 What does it look like?

36 Sensors: Continual Evolution For the Near Future Guardian Sensor 3 Freestyle Libre Glysense Implantable Sensor Raise you hand if you use the FreeStyle Libre Pro routinely in your practice? Dexcom Gen 6 Sensionics Implantable Sensor

37 What s Going On? 85 y/o man, no cognitive concerns, changed 5 years ago to multiple injections from 70/30 premix Mean/SD on glucose testing at home 185/60 testing 2.5 times daily on meter first started to use 18 months ago HbA1c now 11.8% What to do?

38 No glycation gap! Not enough blood on new CMS meter, readings consistently low when compared to FGM

39 Fingerstick BG

40 Sometimes the FLP Gives Us TMI 32 y/o woman with 14 years T1D, divorced for 1 year. Works as a commercial realtor. No children On MDI, stopped CGM as it inhibits my social life Agreed to wear FLP for 14 days Conclusion?

NPH Insulin in 2017 45 y/o man who still had insulin lispro and a few CGMs from last year.

43 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!

44 NPH and Regular, August y/o man, T1D for more than 40 years. Can t afford analogue insulin

45 Raise Your Hand if You Have Patients on Our First Hybrid Closed Loop? Patient still needs to bolus for meals and notify the system for exercise. Won t be for everyone-many love it, others don t want the extra burden on their diabetes, yet others don t find it aggressive enough.

Key Pearls for 670G for Hybrid Closed Loop Patients HAVE to use bolus calculator for auto mode to engage In auto mode, glycemia is maintained by changing basal doses Manual mode basal rates have no

46 Key Pearls for 670G for Hybrid Closed Loop Patients HAVE to use bolus calculator for auto mode to engage In auto mode, glycemia is maintained by changing basal doses Manual mode basal rates have no bearing in auto mode Meal doses: generally need higher doses (ICR), IOB 2-3 hours work best; algorithm determines auto basal, ISF, targets! Programmed manual mode ISF dose not apply in auto mode Calibration of CGM: 3-4 times daily

47 Conclusion Technology for MDI is finally improving, but still a lot of problems with SMBG accuracy and understanding of HbA1c 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

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

Diabetes Technology for the Endocrinologist, 2017 Irl B. Hirsch, MD University of Washington Dualities Research: Helmsley Charitable Trust, JDRF, ADA, NIDDK, CDC Consulting: Abbott, Roche, Intarcia, Adocia,