ADVANCES IN DIABETES TECHNOLOGY: A FOCUS ON CONTINUOUS GLUCOSE MONITORING 9:15 10:15 AM ACPE UAN: 0107-9999-18-124-L01-P 0.1 CEU/1 hr Activity Type: Knowledge-Based Learning Objectives for Pharmacists: Upon completion of this CPE activity participants should be able to: 1. Describe the limitations of self-management of blood glucose and the impact continuous glucose monitoring (CGM) has on diabetes management decisions. 2. Identify patients who would benefit from professional and/or personal CGM. 3. Differentiate among the available CGMs in terms of technical features, benefits and limitations, device compatibility and ease of use. 4. Describe how to utilize the available CGMs in terms of data sharing and data supporting dosing decisions. 5. Integrate relevant real-time and retrospective CGM data and device information into pharmacy practice and management decisions. Speaker: Erin Newkirk, PharmD, BCPS, CDE Erin Newkirk received her PharmD degree from the University of Wisconsin in 2001 and completed a Specialized Residency in Primary Care at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin in 2002. She practiced at the University of Iowa Hospital and Clinics for 6 years before starting at Froedtert & The Medical College of Wisconsin in 2008. Erin has been working in the Endocrine clinic for the past 7 years and is currently spending most of her time working with patients with diabetes who utilize an insulin pump and/or continuous glucose monitor. She has previously worked within Anticoagulation, Transplant, Anemia, Pulmonary and Internal Medicine clinics. Erin has a passion for improving diabetes outcomes and is a certified diabetes educator. Speaker Disclosure: Erin Newkirk reports no actual or potential conflicts of interest in relation to this CPE activity. Off-label use of medications will not be discussed during this presentation.
JUNE 7, 2018 DES MOINES, IA Advancements in Diabetes Technology: A Focus on Continuous Glucose Monitoring Erin Newkirk, PharmD, BCPS, CDE Clinical Pharmacist, Endocrine clinic 1
Disclosure Statement Dr. Newkirk reports they have no actual or potential conflicts of interest associated with this presentation. CPE Learning Objective Describe the limitations of self-management of blood glucose and the impact continuous glucose monitoring (CGM) has on diabetes management decisions Identify patients who would benefit from professional and/or personal CGM Differentiate among the available CGM in terms of technical features, benefits and limitations, device compatibility and ease of use Describe how to utilize the available CGMs in terms of data sharing and data supporting dosing decisions Integrate relevant real-time and retrospective CGM data and device information into pharmacy practice and management decisions 2
CGM devices are available that have a FDA indication for the replacement of finger sticks for making diabetes treatment decisions A. True B. False CGM devices are available that have a FDA indication for the replacement of finger sticks for making diabetes treatment decisions A. True B. False 3
History of Monitoring Glycemic Control 1960s dipstix 2006: 1 st CGM 1980s Blood Glucose Meter Why CGM? Which plane would you rather fly for 15 hours? 4
Varying Patterns for A1c = 7% Brown A, Kennedy L, Runge A, Close K Going Beyond A1c One Outcome Can t Do It All. diatribe [Web site]. Sept 25 2016 https://diatribe.org/beyonda1c. Accessed April 8, 2018 Time in Range: Another Important Parameter Brown A, Kennedy L, Runge A, Close K Going Beyond A1c One Outcome Can t Do It All. diatribe [Web site]. Sept 25 2016 https://diatribe.org/beyonda1c. Accessed April 8, 2018 5
Evidence Supports the Value of CGM Multiple studies have demonstrated the clinical benefit of currently available CGM devices More time in range Less hyper or hypoglycemia Decrease in nocturnal hypoglycemia Lower HbgA1c without added hypoglycemia Baily TS et al Diabetes Technol Ther 2007; 9(3): 203-210. Garg S et al. Diabetes Care 2006: 29(1): 44-50. Deiss D et al. Diabetes Care. 200; 29 (12): 2730-2732. Hirsch IB, et al. Diabetes Technol Ther. 2008;10(4): 232-246; Bolinder J, et al. Lancet. 2016; 388(10057):2254-63. Haak, Thomas, et aldiabetes Therapy 8.1 (2017): 55-73 CGM: Recognized by Professional Societies as Standard of Care American Diabetes Association 2018 CGM + intensive insulin in type 1 diabetes (age 18) to lower A1c and prevent hypoglycemia Can be helpful in lowering A1c in children, teenagers, younger adults American Association of Clinical Endocrinologists (AACE) 2015 CGM use has improved clinical diabetes outcomes by reducing hypoglycemia CGM should be used in all patients who have severe hypoglycemia Consensus of experts calls for wider use of CGM Endocrine Society 2016 Recommends CGM technology in adults and pediatrics with type 1 diabetes CGMs can be used on a short-term, intermittent basis for individuals with type 2 diabetes whose blood glucose is above targeted levels American Diabetes Association. Standard of Medical Care in Diabetes 2018 Glycemic targets Diabetes Care. 2018 Jan; 41 (supplement 1): S55-S64. AACE/ACE Consensus Statement: 2016 Outpatient Glucose monitoring Consensus Statement. Endocr Pract 2016; 22: 231-261. Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy & CGM in adults: An Endocrine Society Clinical Practice Guideline The Journal of Clin Endocr & Metab 2016 101 (11): 2968 2979. 6
CGM Components http://www.dexcom.com/pharmacy/dexcom-cgm-faq http://www.texasdiabetes.com/benefits-of-continuous-glucose-monitors-cgms/ Lag Time: Blood Glucose vs Sensor Glucose Train goes uphill, upward trend in glucose Train goes downhill, downward trend in glucose https://www.freestylelibre.us/cgm-difference Accessed 4/8/18 7
What Types of Data Will We Get? Real-time data Immediate action points Therapeutic CGM data Can be used alone to make treatment decisions Dexcom G5 and G6 Freestyle Libre Retrospective data Identify patterns, fine-tune therapy, behavioral interventions FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions. Food & Drug Administration. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm534056.htm. Published December 20, 2016. Accessed April 8, 2018 FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration. Food & Drug Administration. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm577890.htm. Published September 27, 2017. Accessed April 8 th, 2018 Real-Time Data: Arrow Indicators Rising Glucose SG 160 mg/dl and glucose is rising at a rate of 3+ mg/dl/min. Within 30 minutes the glucose level will be 250mg/dl Reacting to this trend arrow by administering more insulin can help prevent elevated glucose Falling Glucose SG 130 mg/dl and glucose is falling at a rate of 3+ mg/dl/min Within 30 minutes the glucose level will be ~40 mg/dl Reacting to this trend arrow by eating 15 grams of a fast acting carb could prevent hypoglycemia 8
Who is the Ideal Patient for Personal or Professional CGM? Intensive insulin regimen Frequent hypoglycemia Hypoglycemia unawareness Excessive glucose variability Varying and/or intensive activity Patient is 2 years of age or older Pregnant or wants to get pregnant Desire to improve glycemic control Desire to understand behaviors that influence glycemic control J. Endocr. Soc.. 2017;1(12):1445-1460. doi:10.1210/js.2017-00388 Why not just go directly to personal CGM device? 9
Professional CGM Comparison Patient Case: CGM SH is a 72 YOF with type 1 diabetes who presents to endocrine clinic for professional CGM evaluation. She was referred due to suboptimal A1c, recurrent hypoglycemia, and hypoglycemia unawareness. She reported using glucagon 1-3 times per month for the past year with some episodes resulting in the paramedics being called. 10
Patient Case: Professional CGM Meter Log Before CGM Target: 70-180 mg/dl % below target 11% % within target 40% % above target 49% Patient Case: CGM SH returns 3 months after receiving personal CGM No glucagon use or paramedic calls Less rebound hyperglycemia following hypoglycemia Decreased alcoholic intake; eats complex carb/protein snack with alcohol to prevent low BG Rarely stops insulin pump manually for low BG Decreased anxiety over fear of hypoglycemia Feels more comfortable participating in activities she enjoys 11
Patient Case: CGM Order of Priority 1. Prevent hypoglycemia 2. Achieve fasting glucose targets 3. Target post-prandial glucose As HgbA1c approaches goal, post-prandial glucose are the main contributor to hyperglycemia 12
CGM Users Have Lower HgbA1c Regardless of Insulin Delivery Method R KM, et al. Diabetes Care. 2015;38:971-978 Types of Personal CGM Stand-alone CGM Dexcom G4 Platinum G5 Mobile G6 Freestyle Libre Flash glucose monitoring Requires scanning Medtronic Guardian Connect 3 Mobile device only Combination Pump & CGM Dexcom TandemT:Slim X2/Dexcom G5 No options for autobasal adjustments based on CGM data Make treatment decisions with CGM data Medtronic 530G & 630G Enlite sensors 670G Guardian 3 sensors Option for basal automode based on CGM data No treatment decisions with CGM data 13
Dexcom G5 personal CGM Dexcom G5 www.dexcom.com 14
Dexcom: Event Entries www.dexcom.com Trend Arrow Glucose Change From: A Practical Approach to Using Trend Arrows on the Dexcom G5 CGM System for the Management of Adults With Diabetes J. Endocr. Soc. 2017;1(12):1445-1460. doi:10.1210/js.2017-00388 15
Dexcom G5 : Adjusting Insulin Doses using Trend Arrows Post-prandial Monitoring & Treatment Using Dexcom G5 Trend arrows up to 4 hours 16
LEARNING ASSESSMENT QUESTION KL is about to eat 36 grams of carbs and dose 3 units of rapid acting insulin for her lunch (I:C ratio 1:12). Her current sensor glucose is 220 mg/dl and her correction factor is 40 mg/dl with a target glucose is 100 mg/dl which calculates out to 3 units. Her Dexcom G5 trend arrow shows ( with CF between 25 - <50 indicates +2.5 unit insulin dose adjustment). What amount of insulin should she receive 15 minutes before lunch? Which action would most benefit AG? a. 8.5 units of rapid acting insulin b. 6 units of rapid acting insulin c. 5.5 units of rapid acting insulin d. 3 units of rapid acting insulin LEARNING ASSESSMENT QUESTION KL is about to eat 36 grams of carbs and dose 3 units of rapid acting insulin for her lunch (I:C ratio 1:12). Her current sensor glucose is 220 mg/dl and her correction factor is 40 mg/dl with a target glucose is 100 mg/dl which calculates out to 3 units. Her Dexcom G5 trend arrow shows ( with CF between 25 - <50 indicates +2.5 unit insulin dose adjustment). What amount of insulin should she receive 15 minutes before lunch? Which action would most benefit AG? a. 8.5 units of rapid acting insulin b. 6 units of rapid acting insulin c. 5.5 units of rapid acting insulin d. 3 units of rapid acting insulin 17
Dexcom: Data Sharing Dexcom Clarity: Receiver: Must use website Dexcom G4 Share & Medicare G5 users to share data with clinic Need cable Dexcom G5 Mobile app Bluetooth-data automatically uploads to clarity if set up to share data Weekly notifications of key data via smartphone or email Dexcom Studio: Professional G4 Receiver: Must use website Need cable Reset receiver Option to blind device Dexcom Follow app G5, non-medicare Up to 5 people can remotely monitor glucose data Recent FDA approval: Dexcom G6 No fingerstick calibration when using start-up calibration code Found on bottom of applicator on the adhesive strip Verily Dexcom 1 st generation: Easy-to-use, push-button applicator compared to current syringe-like plunger device 10-day sensor life (vs 7 days with G5) Mandatory shutoff No interference with acetaminophen (Tylenol) Urgent low soon alarm: a new feature will alert the user when blood glucose is dropping rapidly and is expected to cross the low threshold will occur within 20 minutes in advance of a potential severe low (55 mg/dl). 1 st integrated CGM or icgm Seamless integration with other diabetes devices Quicker FDA review process for future icgms Targeted ship date: June 2018 No timeline for Medicare approval yet http://www.dexcom.com/g6-cgm-system Accessed 4/8/18 18
FreeStyle Libre personal: Flash Glucose Monitoring www.freestylelibre.us FreeStyle Libre: Sensor Basics www.freestylelibre.us 19
Freestyle Libre www.freestylelibre.us FreeStyle Libre: Glucose Reporting 20
Freestyle Libre Trend Arrows Check Glucose: or arrows, low glucose, glucose going low, no arrow, no glucose or sensor reading does not make sense Libreview: Data Sharing Connect reader via cable to computer to upload data Not compatible with Glooko/Diasend Personal Freestyle libre: Invite to upload from home link or provide practice ID Can set up patient dashboard to flag patients 21
Medtronic: Continuous Glucose Monitoring www.medtronicdiabetes.com Accessed 4/18/18 Medtronic: Sensor Basics www.medtronicdiabetes.com Accessed 4/8/18 22
Medtronic CGM Comparison MiniMed 670G w/guardian Sensor 3 Suspends insulin delivery when BG reaches low glucose limit Resumes delivery when SG levels are at least 20 mg/dl above low limit, or > 40 mg/dl above limit within 30 minutes Proactively suspends insulin: When SG value at or within 70 mg/dl above low limit When SG predicted to reach or fall below level that is > 20 mg/dl low limit within 30 minutes Resumes delivery when SG levels recover (see above), or after 2 hours of suspension Uses target of 120 mg/dl May be adjusted to 150 mg/dl temporarily Reads sensor glucose; adjusts basal rate every 5 minutes May recommend bolus dose if entering BG > 150 mg/dl 23
Medtronic: Trend Arrows SG = Sensor Glucose www.medtronicdiabetes.com. Accessed April 8, 2018 Carelink: Medtronic Data Sharing Carelink Personal Contour Next Link Meter (Reimbursement Support Program 866-296-1436) Link carelink personal account allows clinic to see data Clinic-Carelink Web: upload via CareLink USB device Guardian Connect (stand alone CGM): Turn on Sync to carelink for automatic uploads Up to 5 care partners can view CareLink data & receive customized text message notifications MiniMed Connect (530G pump): automatic uploads to CareLink Personal software Up to 3 Care partners can view CareLink data & receive customized text message notifications Not compatible with Glooko/Diasend www.medtronicdiabetes.com. Accessed April 8, 2018 24
MARD: CGM Comparisons CGM Placement Billing 25
CGM Reimbursement Qualified Clinic Member Ambulatory CGM for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording 95249: patient provided equipment Billed once/device 95250: office provided equipment Billed 2-6 times/year Physician, Physician Assistant, Nurse Practitioner CGM data Interpretation 95251: patient or office equipment With or without patient in office E/M in addition on the same day when a significant and separately identifiable service took place CGM data interpretation (95251) can be billed on an ongoing basis F:\Committees\SEGA\Socioeconomics & Member Advocacy\Website\Website Updates 2018\New and Revised CGM codes for 2018. Accessed 4/8/18 CMS-1676- FC; Medicare Physician Fee Schedule Final Rule, Addendum B updates CY2018. Conversion Factor 35.9996 Professional CGM Work-flow: Outpatient Pharmacy 26
Personal CGM: Coverage & Cost Commercial Insurance Freestyle Libre: Walmart, Walgreens, CVS, Kroeger, Rite-aide If sensors >$75/month: consumer customer service line @ 844-330-5535 Dexcom: Dexcom vs distributor vs Specialty pharmacy Medtronic: medtronic or distributor Medicare coverage: Dexcom G5 & FreeStyle Libre through distributor only Must test BG levels 4x/day Multiple daily insulin injections ( 3/day) Visit in 6 months ago then every 6 months Medicaid coverage: Dexcom G5 (select cases) Personal CGM Selection Type 1 vs Type 2 Hypoglycemia/Alarms Calibrations Therapeutic CGM Ease of Use Pump user Insurance/Cost 27
Home CGM Continuation in Hospitalized Patients? Off-label use Institutional Procedures and guidelines should be developed Patient Waivers Sensors should be removed prior to CT, MRI or X- rays Remove reusable transmitters from sensors to avoid accidental disposal CGM in Hospitalized Patients Accuracy Changes in ph, hematocrit levels, blood oxygen tension, peripheral perfusion Substance interference Who will interpret data and make treatment decisions? How will CGM data be communicated to the nurse? What portions of data should be recorded and archived in the medical record? 28
The Role of the Pharmacist Identify appropriate patients for CGM through pharmacy records and patient interviews Educate patients regarding CGM Develop CGM programs for professional and/or personal CGM Medication Experts Understanding the mechanism and impact are a key component to CGM interpretation CGM is a mechanism for making drug therapy recommendations Questions? Erin Newkirk, PharmD, BCPS, CDE Clinical Pharmacist, Endocrine clinic 29