diabetes technology for the endocrinologist,...
TRANSCRIPT
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Diabetes Technology for the Endocrinologist, 2017
Irl B. Hirsch, MD University of Washington
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Dualities • Research: Helmsley Charitable Trust, JDRF, ADA,
NIDDK, CDC • Consulting: Abbott, Roche, Intarcia, Adocia,
Valeritas, Big Foot
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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
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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
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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
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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”)
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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
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Calculation To Determine SD Target
SD X 2 < mean, may be difficult for some type 1 patients. Formulas only relevant for
mean BG between 120-180
SD X 3 < MEAN SMBG
CGM SD X 3 < MEAN
Better metrics: CV, TIR, TBR, TAR all to be correlated with outcomes
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But For Now: We Have to Download Mostly with Mean/SD
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• Read “aggregate” mean/SD
Example: Richard
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Example: Richard
♦ Read “aggregate” mean/SD ♦ Read frequency of testing
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Example: Richard ♦Read “aggregate” mean/SD ♦Read frequency of testing ♦Review time-specific means/SDs
?
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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
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Available Now (but not yet in US)
Small BG meter, size of
memory stick
Insulin pen
monitor
Mobile Application
Your office
Audible activation
Glucome.com
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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
1. Too much basal Too much prandial with downward trend
Poor prandial replacement Mean/SD 126/47; A1C 6.0%
As is often the case, the A1C doesn’t reflect all of the major challenges are patients are having
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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
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So What is the Goal CV?
Diabetes Care 2017;40:832-38
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ONE Reason Why Downloading Is So Important: Understanding the Mean and Estimated A1C
This patient’s HbA1c is 8.2%. She has a glycation gap due to iron deficiency anemia
24 year-old woman, MDI, using Dexcom, 14 years T1D
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What Alters A1C 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
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
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But even with all of these limitations, HbA1c is actually a more crude test than this
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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 (100-152) 7% 155 (116-194) 154 (123-185) 8% 178 (140-217) 183 (147-217) 9% 201 (163-240) 212 (170-249)
10% 224 (186-263) 240 (193-282)
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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
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SEPT 2014:MEAN 197; SD 75; A1C = 8.7%
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Good basal
60 g CHO
BC: 17U
44 g CHO
BC: 11.5 U
Stayed high: last bolus not enough
No bolus: too much basal?
Insulin given with food
Insulin given with food
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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?
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OCT 2016: Mean = 156; SD = 41; A1C = 7.1%
So What Happened To Our Patient’s Diabetes Over the Next Two Years?
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CSII: What Does The Clinical Endocrinologist Need To Know in 2017?
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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!
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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
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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
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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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Hypoglycemic seizure at 1:30am. Why?
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!
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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%
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CGM SMBG
Toggle cursor: 29 g carb, suggested bolus 2.4 u, delivered 1.7 u
Ouch!
Blip
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Case 8a: Twin Sister! Dexcom, No Pump
Highest average after lunch
Most variability after breakfast and bedtime
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Move the cursor
BAD DAY
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GOOD DAY
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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 stiff-
person’s syndrome • HbA1c prior to SPS Dx usually in the 7-8% range, after Dx
most in 9-11% range. • 75-80% of total daily insulin is basal insulin • What’s going on?
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h
Case 5: AGP from 60 y/o Woman with SPS Feb 2016, HbA1c 10.1%
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CASE 5: The Answer to the Problem
(but you need the download!) No bolus
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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
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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 non-endocrinologists (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
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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 blue-
tooth enabled insulin pens
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What does it look like?
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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?
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NPH Insulin in 2017 • 45 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!
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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