Technology in Diabetes Care: Emerging Level

Transcription

1 Technology in Diabetes Care: Emerging Level Charlotte Parsons ARNP, CDE Christine Fisher, RD, CD, CDE, CPT WADE April 26, 2019 Disclosures to Participants Notice of Requirements for Successful Completion: For successful completion, participants are required to be in attendance in the full activity and complete the program evaluation at the conclusion of the educational event. Presenter Conflicts of Interest/Financial Relationships Disclosures Charlotte Parsons on Speakers Bureau: Dexcom Disclosure of Relevant Financial Relationships and Mechanism to Identify and Resolve Conflicts of Interest: Nurse Planner found no issue with conflict of interest or bias. Speakers agree to the constraints of showing any logos or preference to any product or company. Speakers state slides will be free of any bias. Non-Endorsement of Products: Accredited status does not imply endorsement by AADE, ANCC, ACPE or CDR of any commercial products displayed in conjunction with this educational activity Off-label Use: Participants will be notified by speakers to any product used for a purpose other than that for which it was approved by the Food and Drug Administration 1

2 Objectives Describe why CDE s need to be involved in diabetes technology Describe theory of insulin pump and patient selection Identify insulin pump and CGM option Explain process for transition from multiple daily injections (MDI) to pump therapy Discuss calculations for initial pump settings Describe overview of pump/cgm downloads to fine tune pump settings Role of the CDE Part of the AADE Project Vision framework: Leverage Technology: diabetes educators will be technology experts and data interpreters, trainers and consultants driving care Provide support to patients as they consider, initiate and learn how to use an insulin pump to manage their diabetes Coordinate the plan of care between the prescriber and pump manufacturer during initiation and ongoing pump management Serve as a resource to other health care professionals and families that support individuals who use insulin pumps Continuous Subcutaneous Insulin Infusion (CSII) White Paper, American Association of Diabetes Educators, 2014 Continuous Glucose Monitoring (CGM) 2

3 CGM History What is CGM? A device that measures glucose levels in the interstitial fluid to provide glucose readings continuously in real time and data about glucose trends 3 parts: sensor electrode, transmitter, receiver Gives glucose readings every 1-5 minutes Provides glucose direction and rate of change to help one stay within their target glucose range Can set alarms for: Low Alert High Alert Out of range Trending arrows Low battery How does CGM work? Cengiz E & Tamborlane WV. Diabetes Technology & Therapeutics, 2009.Ward WK et al, Diabetic Medicine,

4 Lag Time and Inaccuracy Glucose changes faster in blood than in interstitial fluid Average lag time estimated from 6-12 minutes. May be more lag time during periods of rapid change May delay alarms for hypo-& hyperglycemia May cause patient to overtreat out of range BG s Recovery from hypoglycemia may take longer to register on sensor CengizE & TamborlaneWV. Diabetes Technology & Therapeutics, 2009.Ward WK et al, Diabetic Medicine, Sources of error Lag time Calibration Best to calibrate when glucose is not changing rapidly Follow good BG checking practices (clean hands, etc.) MARD: Mean Absolute Relative Difference The MARD is the difference between laboratory glucose and sensor glucose. The lower the MARD, the more accurate the sensor. Contour Next 5.4 Dexcom G5/G6 9 One Touch Verio IQ 7.1 Medtronic Guardian Accucheck Nano 7.3 Abbott Freestyle Libre 11.4 Freestyle Freedom Lite 7.5 True Result 13 Accucheck Aviva Plus 7.6 One Touch Ultra Freestyle Lite 8.2 Relion Prime 14.3 Senseonic Eversense 8.5 Ekhlaspour, L., Mondesir, D., Lautsch, N., Balliro, C., Hillard, M., Magyar, K., Russell, S. J. (2016). Comparative Accuracy of 17 Point-of- Care Glucose Meters. Journal of diabetes science and technology, 11(3),

5 Indications for CGM Adults and children who use insulin, particularly those who check BGs often and are on an intensive diabetes management regimen, Frequent hypoglycemia or hypoglycemia unawareness, Blood glucose variability A1c reduction without increasing hypoglycemia, Lifestyle or employment reasons Medicare: MDI 3 injection or more, 4 BG checks per day; Has to be for therapeutic use; In person visit with provider every 6 months; supplies are covered as part of DME Benefits of CGM Determines if glucose levels are within therapeutic goal ranges. Provides a more complete picture of glucose control: Especially postprandial and nocturnal patterns Prospective/ Trend data that can help prevent high and low glucose Additional alert for low/ high glucose Immediacy of the feedback helps identify causality which can help to prevent a re-occurrence. Especially beneficial for patients with hypoglycemia unawareness or fear of hypoglycemia. Improved provider confidence in therapy changes Makes artificial pancreas systems possible Limitations of CGM Lag time which may delay alarms for low glucose as well as recovery The sensor is only as accurate as the calibrations entered Technology still requires a lot from the user You have to wear it to get benefits from it. Wearing a device continuously can be a burden Site reactions, skin rashes (to adhesives); pulling off, falling off, sweating off; losing transmitter or receiver; transmission issues at night; malfunctioning sensors; and silencing of alarms if smartphone is on vibrate or silent mode High costs for sensors and replacing system components Prohibitive amounts of paperwork to obtain approval for coverage 5

6 Patient education CGM vs BG; lag time Optimizing calibration How to utilize trend data (real-time data) Alarm fatigue Turn off predictive alerts to start Set low alert to a higher glucose than threshold suspend limit Goal is to reduce lows and detect them before suspension Motivating continued use of CGM FOCUS on the positives-celebrate the successes THEN talk about the challenges Engage the user and their family in personal goal setting Set realistic and actionable alerts ONLY Support them in use-ongoing discussion of benefits and challenges the benefit of real time CGM is primarily seen in patients who regularly wear their devices and appropriatly utilize the glucose data provided -Pettus and Edelman FDA-approved CGM devices Freestyle Libre Dexcom G6 Medtronic Guardian connect Sensionic Eversence 6

7 Freestyle Libre No calibration required Sensor life 14 days with 1 hour warm up No real time high/low alerts Therapeutic use Dexcom G6 No calibration needed Sensor life 10 days with customizable alerts for different times and days Real time alerts for high, low, rate of change, predictive urgent low Therapeutic use Approved sensor life of 7 days Medtronic Guardian Connect Requires calibration at least once every 12 hours or stops generating data Real time alerts for high, low, rate of change or predictive low/high Not for therapeutic use 7

8 Senseonic Eversence Requires MD appointments and procedures every 90 days and additional associated costs Lasts up to 90 days (under the skin) On-body vibration alerts (via the transmitter) when blood sugar high or low Requires twice daily calibrations Not for therapeutic use Continuous Subcutaneous Insulin Infusion (CSII) History of Insulin Pumps Biostater Mill Hill Infuser Auto-syringe & Minimed 502 8

9 What is an insulin pump? Theory: microcomputer designed to provide a constant dose of insulin and to make extra insulin available to cover carbohydrates and to correct high blood sugar Type of insulin used: Fast acting only (Novolog, Humalog, Apidra, Fiasp) Basal: Constant background dose; can have multiple basal rates Bolus: For carbohydrates and/or blood sugar correction Insulin is infused under the skin through cannula (tiny tube) or needle that is connected to a reservoir in the pump or a separate tubeless POD. The infusion set is changed every 2-3 days. Chase MD, P.H and Messer, L. Understanding Insulin Pumps & Continuous Glucose Monitors, 2nd ed Indications for insulin pump therapy Things to consider Type 1 versus Type 2 Insurance- 4 year commitment, Medicare requirements Current regimen Current behaviors-carbohydrate counting, testing blood sugars Physical limitations-dexterity, vision, hearing, Continuous Subcutaneous Insulin Infusion (CSII) White Paper, American Association of Diabetes Educators, 2014 cognition Pick Your Pump: What Is Most Important? Ease of Use Features How much insulin does it hold? What type of battery does it use? What are the bolusing options? Tubing or No Tubing That is The Question Waterproof Continuous Glucose Monitor Dexterity and Vision Support Meter Connectivity Insurance coverage 9

10 Benefits Better glucose control Increased flexibility of basal delivery Precise bolus dosing Improved quality of life Limitations Cost Infusion Site Issues Diabetic ketoacidosis Fear of feeling dependent on a pump Medtronic 630G Reservoir holds up to 300 units Color screen Vibrate/adjustable volume alert Suspend on low technology Improved guardian sensor Linked glucose meter 10

11 Medtronic 670G Reservoir holds up to 300 units Color screen Vibrate/adjustable volume alert Suspend before low technology Closed loop technology with auto mode with auto basal adjustments for high and low glucose trends Improved guardian 3 sensor Linked glucose meter Omnipod Dash DASH PDM-blue tooth technology Tubeless waterproof POD Small size 1.6 x 2.4 Volume 200 units POD life 72 hours Automatic cannula insertion Color screen Must be within 5 feet to deliver a bolus Tandem X2 Reservoir volume 300 units Touch screen Downloadable updates as features advance Charge with USB Communicates with Dexcom G 5 or G 6 11

12 Initiating Insulin Pump Therapy Basal Can take the injectable basal (Lantus, Basaglar, Levemir, Touijeo or Tresiba and divide by 24 (hours per day) Decrease injectable basal by 20% and then divide by 24 hours Use a weight based formula Bolus All pumps have this feature Insulin to carbohydrate ratio (ICR) Insulin Sensitivity factor (ISF) Target Blood Glucose Insulin on board or active Insulin Bolderman, K. Putting Your Patients On The Pump American Diabetes Association Case Study 23 year old female diagnosed with T1D at age 18 Ht: 63 inches Wt: 120 # BMI: Currently on MDI of Lantus 30 units ICR of 1:8 ISF: 1:30 Current correction starts at 150 mg/dl Current total daily insulin: 52 units Current A1C: 8.2% Calculating initial settings Reference: Grunberger, G, Abelseth, J, Bode, B., et al. Consensus Statement by the American Association of Clinical Endocrinologist/American College of Endocrinology Insulin Pump Management Task Force. Endocrine Practice. 2014; 20 (5),

13 Download Review in Tidepool What are the things to look at on a download report? Pump use: BGs per day; overrides, infusion set changes; manual boluses TDD = basal + bolus 50:50 ratio? Time in range; % high, % low; patterns? Hypoglycemia: patterns, causes - stacking, heavy basal, activity Hyperglycemia: patterns, causes, carb and correction boluses, over-treating hypo What do you see Download Options 13

14 Define patient teaching opportunities using insulin pump/cgm download Exercise Bolus habit Nutrition Technology troubleshooting Patient education Pump habits-infusion changes, suspending? Basal/bolus testing as strategy for fine tuning Teach pumpers to be prepared Insulin vials or pens Extra infusion set/reservoir or pod Treatment for hypoglycemia Extra batteries or charging cord What s next on the horizon? 14

15 Conclusion We have a lot to learn The future is bright Technology will revolitionize diabetes care CGM will drive CSII and closed loop systems Part of the AADE Project Vision framework: Leverage Technology: diabetes educators will be technology experts and data interpreters, trainers and consultants driving care Thank you 15