5/16/2018. Integrating Diabetes Technology Into your Practice : Insulin Pump Therapy. Diosclosures. What exactly is an Insulin Pump?

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1 Integrating Diabetes Technology Into your Practice : Insulin Pump Therapy Lucia M. Novak, MSN, ANP BC, BC ADM, CDTC Director, Riverside Diabetes Center, Riverside Medical Associates Riverdale, MD Adjunct Assistant Professor, Uniformed Services University of the Health Sciences Bethesda, MD Diosclosures Speaker s Bureau: Novo Nordisk; AstraZeneca; Janssen Consultant: Sanofi; CeQur; Intarcia Advisory Board: Sanofi; Intarcia What exactly is an Insulin Pump? Not a dumb question! Not a simple answer! Line Pumps Most of the pumps currently available Medtronic Tandem Animas Accu Chek Combo/Spirit Asante Patch Pumps OmniPod V Go OneTouch Via (bolus only, not yet) PAQ (not yet) 1

2 Pump Manufacturer Other 1% Roche <1% Animas 18% Medtronic 52% Tandem 12% Insulet 17% T1D Exchange data What Do Insulin Pumps Do? Delivers insulin Continuous basal delivery automatically Programmed adjustable Bolus doses to address meals or correct elevated blood sugars directed by the user calculations are programmed to help the user with the math What DON T Insulin Pumps Do? At least not yet! Automatically respond to changes in blood glucose without any input from the user Who Can Have One? Anyone with Diabetes that requires basal/bolus insulin administration Who Should Have One? Anyone with diabetes that requires basal/bolus insulin administration and is doing so ( 4 injections; 4 SMBG) motivated to achieve optimal glucose levels willing and able to perform required tasks to ensure safe/effective actively participating in their diabetes management and with their health care team realistic expectations ~350,000 to 515,000 of people with DM Grunberger, G, et al. (2014). Endocr Pract,20, Peters, A, et al. (2016). J Clin Endocrinol Metab, 101,

3 Who Should Order one? Providers who possess the necessary knowledge, skills and resources Only about 2000 physicians currently prescribe pumps Grunberger, G, et al. (2014). Endocr Pract,20, Clinical Characteristics of Patients T1DM Neg. c pep, a/o pos. Antibodies Labile glucose Hypoglycemia (severe, unaware) Dawn Phenomenon Extreme insulin sensitivity T2DM +c peptide, but requires MDI Erratic lifestyle Dawn Phenomenon Severe IR Microvasc/macrovasc complications Grunberger, G, et al. (2014). Endocr Pract,20, Pros and Cons Pros Attached Convenience/discreet Easier Problem Solving Fewer lows Precise insulin dosing Improved glucose control (hopefully) More compatible with life/living Cons Attached Inconvenience/indiscreet Site infection/irritation Inc. risk DKA/hyperglycemia Cost! More work Training! Bottom Line: Patient s disease, patient s choice 3

4 One Month of Insulin Doses at least 4x daily OR THIS? THIS? x10 Setting the Right Expectations Unrealistic The pump will cure my diabetes I won t have to check as much I can eat anything I want My blood glucose will be perfect It will be as easy to learn as a meter Realistic I will feel better I must monitor very frequently I will have more freedom with my food choices I will have better control with fewer lows It will take time to learn and adjust to the pump Cost Is a SIGNIFICANT Consideration Average start up price can be as much as $7500. Disposable infusion supplies will cost a minimum of about $250 per month. Cost of insulin Blood Glucose monitoring supplies CGM supplies Insurance coverage varies widely, but is often 80%. Annual Deductibles need to be met For Medicare INSULIN Prescritions: MUST INCLUDE USE WITH INSULIN PUMP so that insulin is covered by part B!!!! 4

5 Pump Trainer Half day for Mechanical Training Diabetes Educator/Nurse Practitioner Two hours with CDE/NP Return in two days Return in 1 wk, 1 mo, 2 mo, then every 3 mos Fax/ BG 1 2 weekly for 1 2 months Ongoing Return to Primary Provider within 3 6 months Annual return for review & continued education Why All The Visits? Allow the patient to adjust to new therapy Incorporate into life style and make changes as needed Provide basic education, adding information each visit Work on improving BG control as well as providing therapy that enhances life style Teach higher level skills as patient is ready Empower patient to own new therapy Provide an ongoing relationship with team 5

6 No Team? Still Can Pump! Pick What Works For You Refer to sites that have a pump program Pump Company Trainer and clinical Teams Pump Clinical Experts Referrals Shared visits Know the pump and the therapy Pumping Basics Type of insulin used Only fast or rapid acting insulin Aspart, Lispro, Glulisine most commonly Regular U100 Regular U500 Must change insertion sites every 3 days maximum but FAR less needle insertion than MDI! Must test BG at least 4x daily or use CGM Device specific for # fingersticks needed Lowers risk for hypoglycemia, BUT increases risk for hyperglycemia Talk the Talk: Pumping Lingo TDD= Total Daily Dose (of insulin) Basal + all bolus doses administered in 24 hours (average for 1 week) x x weight in lbs (or 0.5 x wt in Kg) Basal= approx. 50% of TDD divided over 24 hours 18 units 24 hours = 0.75 units/hour ICR= Insulin to carbohydrate ratio How many carbohydrates 1 unit of insulin will adequately address 500 TDD = 1:14 (can round to 15 for ease) 1:10; 1:15; 1:20; 1:5; 1:3 ISF= Insulin Sensitivity Factor How many mg/dl 1 unit of insulin will reduce blood glucose (over a 4 5 hours) 1700 TDD of pump 6

7 Talk the Talk: Pumping Lingo (cont.) Blood glucose target The BG that pump bolus calculator uses to determine bolus doses Choose a number rather than a range IOB (insulin on board) The amount of insulin still working from a previous bolus Subtracted from next bolus to prevent insulin STACKING Insulin stacking Administering bolus doses too close together (< 4 to 5 hours apart) and causing overlapping of peaks LEADS TO HYPOGLYCEMIA Incorrectly attempting to correct an elevated BG Bolus Calculator: Does the Math! All of the aforementioned items are determined by patient and HCP and then entered into the pump. The patient MUST enter blood glucose AND Grams of carbohydrates preparing to eat The pump will calculate and suggest a bolus dose Pt will either accept the suggested dose or override (take more or less depending on other circumstances (activity, illness, etc.) Comparing Pumps Some Things to Consider Basal increments; number of profiles; temporary settings Bolus increments; max bolus dose; duration of delivery; mode of delivery (quick; standard; extended/square; multiwave) Size yes, it matters! Weight Communicates with other devices Reservoir; priming; rechargeable; backlight; readability; navigation/user friendly; touch screen; waterproof; lockout; alarms; CGM compatible or integration; software/reports; wearability Customer Service Cost/insurance 7

8 Clinic Name: Address: To whom it may concern: The following patient,, is using a Dexcom Continuous Glucose Monitoring System that is not removable and needs to remain connected to the patient. This prescribed medical device is comprised of three components: 1. A small sensor that is imbedded underneath the skin that measures glucose levels. 2. A transmitter that is fastened on top of the sensor that sends data wirelessly to a compatible smart device or a receiver. 3. A display device which can be the Dexcom Receiver or a compatible smart device. Because the sensor is inserted under the skin, and is connected to the transmitter, neither the sensor nor the transmitter can be removed from the patient. Sincerely, Doctor s Name: Title: State License Number: 5/16/2018 Other Considerations Supplies to order Insulin (vials) consider month of TDD; each vial discarded after 28 days of initial use Tubing; insertion kits (frequency of site changes every 2 to 3 days) Test strips specific to compatible meter (if applicable) Emergencies: Insulin Pens AND needles or insulin syringes (to be used with vial) Glucose tablets; Glucagon kit Medic Alert ID Travel: Exposure to X ray (TSA screening) ( Notice of Medical Device Letter) OmniPod pods and PDAs can safely pass through airport X Ray machines Carry on bags! And other storage Time zone and climate changes Delays/cancellations Dexcom: Notice of Medical Device Notice of Medical Device airport and travel guide flying Dexcom cgm Tandem: Flying with Your Tandem insulin Pump source/general guides/ml _a_print_info_card_tsa.pdf?afvrsn=9bad3ed7_2 8

9 Medtronic: Airport Information Card (User Guide) Pumps available in US as of 2014 Which are still available in US today? It has only been 4 years! just sayin!! Grunberger, G, et al. (2014). Endocr Pract,20, Sensor Enhanced Pumps 9

10 Medtronic MiniMed Paradigm Revel FDA approved for 7 17 yrs old (pediatric system)* and 18 yrs old + (nonpediatric system) MiniMed 530G FDA approved for 16 yrs old + Threshold Suspend (TS) feature when sensor is reading low Animas Vibe FDA approved for 2 yrs old + No remote Company no longer in pump business Tandem t:slim G4 FDA approved for 2 yrs old + Tandem t:flex Holds 480 units of insulin Demand low, no longer in production The NEWER stuff is pretty amazing though!! MINIMED TM 630G with ENLIGHT TM Sensor SMARTGUARD TM TECHNOLOGY: Low Glucose Suspend (for up to 2 hours) 30 minute PREDICTIVE ALERTS 10

11 t:slim X2 TM with Dexcom G5 CGM integration COMING SOON!!!! Predictive Low Glucose Suspend With Dexcom G5 (and eventually G6) Control IQ Hybrid Closed Loop with Automatic Correction Bolus with Dexcom G6 Only 2 glucose tests daily (calibration). It is only CGM system FDA approved for dosing of insulin. ALL THAT AND WITHOUT FINGERSTICK TESTING!!!!! BUT The Future is NOW! The MiniMed 670G System CGM GUIDED BASAL INSULIN DELIVERY SYSTEM 11

12 BEFORE USING 670G Basal rate: 1u/hr x24 hr ICR 1:15 CF: 50 BG Target: 110 mg/dl Current A1c: 8.4% How does the Auto mode feature work? AUTOMATED BASAL INSULIN DELIVERY Auto Mode: 48 hours before it kicks in (we usually wait 2 weeks in Manual mode) Warm up period minutes Delivers automated basal insulin doses every 5 minutes Automated basal target = 120 mg/dl Temporary target of 150 mg/dl can be used Bolusing & Meals Must enter blood glucose (BG) readings and/or carbohydrate grams ( 15 minutes before meals) NOW USING 670G: Basal rate: MN to 12: 1 u/hr 12 to 22: 1.1 u/hr 22 to MN: 1 u/hr ICR 1:15 CF: 50 BG Target: 110 mg/dl CURRENT A1c: 7% 12

13 One Future Bionic Pancreas: The ilet Coming soon to a Body Near You!! INSULIN GLUCAGON Not Just for Type 1! A1c Reduction of 1.1% in Insulin Pump Group 9% 8.6% 7.9% 13

14 Lower Total Daily Insulin Dose in PUMP Group 122u 97u Disposable Patch Pumps for Type 2: V Go vgo.com/ vgo.com/hcp/prescribing dosing 14

15 Disposable Patch Pumps for Type 2: PAQ (not yet available in US) paq/ paq/ Disposable Patch Pumps for Type 2: OneTouch Via (not yet available in US) Bolus delivery only (must inject basal separately) 2 unit increments Reservoir: 200 units rapid acting 72 hours wearability us center/press releases/new data show on demand mealtime insulin delivery system enabled morethan fifty percent of patients to report improved dose compliance 15

16 Potential Pump Candidates Case Study 1: JV 54 yr old male with Type 2 x 12 years s/p kidney transplant in 2011 Control poor pre transplant but now pt doing great Has not been testing but knows sugars are perfect except for occasional AM hypo Takes Lantus 36 SQ daily and Amaryl 4 BID You continue regimen but ask him to begin testing AC and HS You send for A1c Case Study 1: JV Only preforms SMBG in morning too busy at work A1c: 10.3% 16

17 Case Study 2: CZ 29 y.o female with Type 1 for 15 years A1c s ranging from % over the past two years Basal bolus regimen Lantus 12 and Novolog qac Checks her blood sugars qac and qhs as directed Case Study 2: CZ Not interested in pump therapy at this time Very frustrated, wants to start trying to conceive Despite fingersticks being good on log, A1c never at target! Discuss checking PP with patient, keeping food log, and suggest Real Time CGMS 17

18 A1c today in office 7.8% Case Study 3: E.C. 21 yo female college student on MDI and CGMS A1c= 11.7% Prescribed Lantus 12HS and Humalog Insulin/Carb Ratio (ICR)= 1/8, and Insulin Sensitivity Factor= 1/50 Target of 120 mg/dl Complaining of am hypoglycemia 18

19 Characteristics of Patients Most Often Meeting A1C Goals A1c <7.0% vs A1c >9.0%: more frequent self monitoring of blood glucose missing fewer insulin doses bolusing before meals rather than at the time of or after meal using meal specific insulin:carbohydrate ratios more often using insulin pumps T1D Exchange data 19