Incorporating CGM Into Clinical Decision

Transcription

1 Incorporating CGM Into Clinical Decision Making Etie Moghissi, MD, FACE Clinical Associate Professor, David Geffen School of Medicine UCLA 1

2 It is Time to Think Beyond A1C

3 HbA1c is simple to administer and interpret, but only provides a 90 day average Patient A Patient B Patient C HbA1c = 7% HbA1c = 7% HbA1c = 7% 18% 24% 58% 100% In-Range Hyper Hypo Note: Patient data for illustrative purposes only 3 of 45

4 Limitations of Current Glucose Monitoring Methods A1c Standard of care, however: The extent to which hypoglycemia and hyperglycemia occur are unknown Unknown glucose variability SMBG Provides glucose information for only points in time, however: Hypoglycemia and hyperglycemia are often missed Overnight data is impractical Logbooks are difficult to interpret Sources: BBC, US T1 Diabetes Exchange 2011, dq&a Q42011, ADC Category Revenue Estimates.

5 CGM reveals glucose patterns not seen in SMBG SMBG CGM Note: Patient data for illustrative purposes only 2018 Abbott. ADC- 5 of v1.0 04/18

6 Common Sources of Error in A1C Interpretation Directionality of Effect Source of Error Falsely elevated A1C Iron deficiency Anemia Hemoglobinopathies Race: African American, Hispanic, Asian Falsely low A1C Hemolysis Reticulocytosis Hemoglobinopathies Post-hemorrhage or post-transfusion Drugs: Iron, erythropoietin, dapsone Uremia Splenomegaly Rubinow KB, Hirsch IB. Reexamining metrics for glucose control. JAMA. 2011; 305:

7 CURRENT STATE OF DIABETES MANAGEMENT % 70 % Average A1C% level of type 1 patients 1 Insulin using patients above ADA A1C target of 7% 2 Patients not taking their insulin as prescribed 3 The barriers to good glycemic control are wide-ranging and far-reaching, contributing not only to long-term complications but also hindering a patient s day-to-day quality of life. 4,5 1 Miller K, Foster N, Beck R et al. Current State of Type 1 Diabetes Treatment in the U.S.: Updated Data From the T1D Exchange Clinic Registry. Diabetes Care. 2015;38(6): Selvin E, Parinello CM, Daya N, Bergenstal RM Trends in Insulin Use and Diabetes Control in the U.S.: and Diabetes Care. Diabetes Care, November Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet. Med. 29, (2012). 4 Rombopoulos G, Hatzikou M, Latsou D, Yfantopoulos J. The prevalence of hypoglycemia and its impact on the quality of life (QoL) of type 2 diabetes mellitus patients (The HYPO Study). Hj. 2013;12(4): Vanstone M, et al. Patient Perspectives on Quality of Life With Uncontrolled Type 1 Diabetes Mellitus: A Systematic Review and Qualitative Meta-synthesis. Ontario Health Technology Assessment Series; Vol. 15: No. 17, pp. 1 29, 2015.

8 A1C 7.8% What do you think of this patient s control? Estimated A1c is an estimated value and does not replace the lab HbA1c blood test.

9 HOW CGM BENEFITS PATIENTS Reduces in A1C and hypoglycemia 1 CGM use, not insulin pump delivery, drives A1C reduction 2 Convenience and comfort Less pain and hassle with fewer fingersticks Context with glucose trends and patterns provide more information for treatment decisions Reduction of time in hyperglycemia (>300mg/dL) 1 Improvements in Quality of Life 3 Reduction of time in hypoglycemia, particularly nocturnal (<60mg/dL) 1 Increase of time spent in target range 1 Significant A1C reductions with CGM use regardless of education level, math ability, and age 1 An average 86% reduction in number of events requiring emergency medical treatment after 1 year of CGM use 4 1.Beck R, Riddlesworth, T, Ruedy, K, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults with Type 1 Diabetes Using Injections for Insulin Delivery: The DIaMonD Randomized Clinical Trial. JAMA Soupal J et al. COMISAIR Study. DTT Volume 18, Number 9, GOLD Study, JAMA, Jan Chamberlain JJ et al. Impact of Frequent and Persistent Use of Continuous Glucose Monitoring (CGM) on Hypoglycemia Fear, Frequency of Emergency Medical Treatment, and SMBG Frequency After One Year. J Diabetes Sci Technol Sep 9. pii: [Epub ahead of print].

10 CGM provides a wealth of data, but adoption and retention remain a challenge Discomfort and cost are barriers to adoption 1 Calibration 2-4 finger sticks per day 2,3 Multiple Components 2,3 High Cost Patients: $200 - $700 per month 4 HCPs: $700 - $1,400 per system 4,5 1. Wong, J. et al (2014) Real-Time Continuous Glucose Monitoring Among Participants in the T1D Exchange Clinic Registry. Diabetes Care. 37: Dexcom G4 Platinum User s Guide (LBL Rev 04 MT 22434). Accessed October 19, Medtronic Enlite Sensor User Guide (REF MMT-7008B, MMT-7510) and Accessed October 19, Source: Dexcom List Price, Cost estimates exclude SMBG meter and strip supplies required for sensor calibration (2x per day) 5. Medtronic ipro2 Order Form, 2015; Dexcom Earnings Call Abbott. ADC v1.0 05/18 10 of 30

11 Professional CGM Options Professional CGM G4 Platinum Professional 1 ipro 2 2 Free Style Libre Pro 7-day sensor wear Minimum twice daily fingerstick calibrations Patient wears sensor, transmitter and receiver Equipment disinfection after each use 6-day sensor wear 3 to 4 daily finger-stick calibrations Patient wears sensor and transmitter Equipment disinfection after each use 1. Retrieved November Retrieved January day sensor wear No need for daily fingerstick calibrations Sensor is applied to the back of the upper arm and activated during an office visit. Patient wears the sensor up to 14 days without any interaction with the device. 3-SCAN IN Sensor is scanned at the next visit.

12 Available Glucose Sensors Type of CGM Abbott Freestyle Libre Medtronic Enlite Guardian Sensor 3 Dexcom 4, 5, 6 Calibration necessary? No Yes Yes Sensor duration 10 days 6 days 7 days Audible alerts for high and low glucose No Yes Yes Trend arrow displayed? Yes Yes Yes Connectivity to insulin pump No Yes Soon Start-up cost of system $360 (3 sensors, 1 reader) $567 (5 sensors) $790 (Receiver, transmitter and 4 sensors)

13 Professional CGM Type of CGM Primarily owned by Purpose Professional CGM Clinician Facilitate treatment adjustments, patient coaching and education through analysis of patterns and trends of captured data Type of data Retrospective Key insights data can provide Snapshot of progress Need for therapy adjustment Glucose patterns

14 The Dexcom Receiver (Touchscreen) FEATURES OF THE NEW DEXCOM RECEIVER Compatible with Dexcom G5 Mobile CGM System Touchscreen receiver Larger display screen than the current G5 receiver Portrait orientation to mimic the same user interface as the G5 app Mag glass feature is shown along with trendline Up to 3 hours of backfill Same alerts and alarm with all other functionality remaining the same as current G5 receiver Alerts updated to include contextual help Brightness controls (3 settings) Screen lock to prevent accidental button presses Comes with 3 color cases (black, pink and blue)

15 Unknown Daily Glucose Fluctuations AGP graphs of four different T1 DM patients (each with an A1c of between 7.6 and 7.7%) 1 1. Dunn, Hayter, Doniger, Wolpert (2014). Journal of Diabetes Science and Technology. 8(4) doi: /

16 How the FreeStyle Libre Pro System works Application Recording Download Interpretation HCP applies a sensor onto patient at clinic. Sensor is worn for up to 14 days and records glucose readings continuously. Patient returns to the clinic. HCP scans the sensor to download the glucose data. Reports generated from the data are interpreted by an HCP and used in patient consultation. <5 min* Up to 14 days <5 min* ~10 min* Reimbursable under CPT Reimbursable under CPT FreeStyle Libre Pro Operator s Manual *Estimated time

17 Rationale for Retrospective CGM Indications for retrospective CGM 1 HbA1c above target with suspected post meal hyperglycemia or under utilization of insulin/oral medication Hypoglycemia, hypoglycemic unawareness Value of retrospective CGM utilization 2 Provision of actionable information on patterns and trends, regardless of underlying therapy

18 Personal CGM 18

19 PERSONAL CGM G5 MOBILE CGM SYSTEM FEATURES & BENEFITS 1 1 BENEFITS OF DEXCOM CGM Convenience and comfort Approved for dosing decisions (LBL015022) Smartphone compatible (ios and Android) 1 1) Display Device: Receiver or Smartphone 2) Transmitter 3) Sensor (shown with transmitter) 4) G5 App (ios compatible) View list of compatible devices at dexcom.com/compatibility 2 dq&a, Q1-17, 3 G5 Mobile CGM User Guide, Rated highest in user loyalty scores 2 Patient Care teams for onboarding, training and ongoing support (LBL013496) Only CGM designated as therapeutic CGM and approved for Medicare coverage (LBL015102, LBL015099) Only CGM approved for children as young as 2 years age 3 Sharing and following with up to 5 individuals for support and peace of mind 3 LBL014664/ (G5 Adult Brochure/Ped) LBL014665/ (G5 Adult slim jim/ped)

20 Real Patient Case Study 2 Darryl H. Darryl H. is a 53 year old male, diagnosed Type 2 DM 9 years ago. When Darryl was seen in Februrary, he had an HbA1c greater than 15%. His BMI was Darryl started on Tresiba at 50 units and Trulicity at 1.5 mg/week plus Metformin. 3 months later his HbA1c is 8.8% The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary.

21 Real Patient Case Study 2 Darryl H. The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary.

22 Contributing Factors to Glycemic Variability 1 Food choices Medications Activity Other factors Stress Sleep (shift workers) Illness or infections Other medications 1 Brownlee & Hirsch Glycemic variability: a hemoglobin A1c-independent risk factor for diabetic complications. JAMA 2006;295: doi: /jama

23 Meet Christopher Real Patient Case Study Started with FreeStyle Libre Pro System and now on FreeStyle Libre System 30 year old male Type 1 diabetes for 10 years Initial insulin pump, not well controlled, now on MDI Tresiba 10 units and Humalog with meals I/C: 1/10, CF: 1/60 HbA1c 7.0% to 7.7% BMI 18.6 SMBG < 70 mg/dl before meals Why CGM Improve day to day diabetes management The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary Abbott. ADC v1.0 04/18 23 of 45

24 Christopher - FreeStyle Libre Pro System The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary Abbott. ADC v1.0 04/18 24 of 45

25 Christopher - FreeStyle Libre Pro System Repeated Study The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary Abbott. ADC v1.0 04/18 25 of 45

26 Christopher - FreeStyle Libre System, Personal CGM The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary Abbott. ADC v1.0 04/18 26 of 45

27 Christopher - FreeStyle Libre System, Personal CGM The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary Abbott. ADC v1.0 04/18 27 of 45

28 Christopher - FreeStyle Libre System, Personal CGM The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary Abbott. ADC v1.0 04/18 28 of 45

29 Meet Aaron Real Patient Case Study FreeStyle Libre System 30 year old male Presented with newly diagnosed diabetes HbA1c 11.4% Weight 234 lb.; BMI kg/m 2 Strong family history of T2 diabetes Very resistant to start insulin StartedMetformin and Tresiba, 20 units daily Why personal CGM Patient is motivated to come off insulin He wants to prove me wrong that he can do it with diet and exercise The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary Abbott. ADC v1.0 04/18 29 of 45

30 Aaron - FreeStyle Libre System, Personal CGM The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary Abbott. ADC v1.0 04/18 30 of 45

31 Aaron - FreeStyle Libre System, Personal CGM 2018 Abbott. ADC v1.0 04/18 The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary. 31 of 45

32 Aaron - FreeStyle Libre System, Personal CGM The case study provided is intended to be used for educational purposes only. Individual symptoms, situations and circumstances may vary Abbott. ADC v1.0 04/18 32 of 45

33 Easy to access for patients with diabetes FreeStyle Libre System is available at major retail pharmacies 1 FreeStyle Libre System is now covered by Medicare, for patients who meet the eligibility criteria 2 1. Participating pharmacies are subject to change without notice 2. Local Coverage Determination (LCD): Glucose Monitors (L33822), Noridian Healthcare Solutions. Effective January 12, Public version updated on May 12, Abbott. ADC v1.0 04/18 33 of 45

34 42 year old construction worker T2DM x 5 years How would you interpret this glucose log? A1C 7.6 % How would you safely and effectively adjust his medical regimen? Meds: Metformin 500 mg BID IDegLira (xultophy) 22 u/d

35 Libre AGP

36 Basic Principles of CGM (AGP-Ambulatory Glucose Profiling) Interpretation Displays time of day when BG levels are highest or lowest Displays time of day with greatest variability and magnitude of variability A1C estimation is based on average daily BG readings. Note the wide range of mean glucose based on A1C levels Variability BELOW medium is high, suggesting trending towards hypoglycemia 10 % curve drops below 70 mg/dl Always fix hypoglycemia before addressing hyperglycemia

37 Time in Range As a general rule, patients with > 50 time in range will have an A1C < 7 % Range target is mg/dl Below 80 mg/dl should be < 3 % of total values

38 Bob Age 48 Duration of T2DM 9 years Before After A1C 8.7 % 7.4% Meds Metformin 500 mg BID BG Monitoring Finger sticks AGP Symptoms Fatigue, paresthesias, Metformin 500 mg BID + IDeg Lira 30 units daily None

39 Therapeutic Interventions Based On Data Downloaded At This Office Visit Before CGM After CGM

40 Robin 67 year old woman with T2DM for 10 years Current meds: Glargine U units at 9 PM daily Linagliptin 5 mg q d A1C= 9 % Chang e Glargin to degludec DC Linagliptin Begin Liraglutide 0.6 u q am Download in 2 weeks

41 Libre AGP

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43 In Summary, It Is Time to Think Beyond A1C! Offer CGM to as many patients as possible Discover previously unknown hyper and hypoglycemic events Measure glycemic control directly rather than 90 days average (A1C) Observe metrics such as glycemic variability, time spent within, below or above targeted glucose range throughout the day Determine the duration and severity of unrecognized hypoglycemia, especially nocturnal Provide actionable information derived from the CGM report Analyze glucose effects of targeted pharmacologic interventions (both fasting and post-meal glucose values) Evaluate the effect of exercise on glycemic control Provide behavioral interventions based on real-time glycemic values