Sarrah Morrison BScN,RN,MBA Certified Pump Trainer

Sarrah Morrison BScN,RN,MBA Certified Pump Trainer The Author, Expert Reviewers and Presenter declare no real or perceived conflict with the sponsor company. CCCEP # 1213-2013-733-L-P Expiry March 25, 2014

Disclosures Sarrah Morrison BScN,RN,MBA, Certified Pump Trainer Received honoraria from Medtronic Tino Montopoli Owner/manager Diabetes Depot and Stutt s Pharmacy Received honoraria from Lifescan, Roche, Sanofi-Aventis, Agros Health, Drug Trading Corp., Medtronic and insulinpumps.ca Karen Lyn RN,CDE,Certified Pump Trainer Director of Clinical Education at insulinpumps.ca Melany Hellstern President: insulinpumps.ca

After completing this session pharmacists will be able to: Describe how continuous subcutaneous insulin pump therapy works Identify the benefits of insulin pump therapy over multiple daily injection (MDI) Describe the latest advancements in insulin pump therapy Identify the supplies that insulin pumpers require and how you can help them Fill insulin pump reservoirs and insert 90 and 30-45 angle infusion sets

Presentation Overview Diabetes complications Physiologic insulin secretion What is an insulin pump? Insulin regimens Factors affecting the action of injected insulin Continuous Subcutaneous Insulin Infusion (CSII) Compare CSII and multiple daily injections (MDI) Candidates Pumps available in Canada Infusion sets and infusion set selection Supplies Financial Issues

Diabetes Complications Macrovascular Stroke Microvascular Diabetic Eye Disease (retinopathy and cataracts) Coronary Artery Disease Nephropathy (diabetic kidney disease) Peripheral Vascular disease Neuropathy Foot problems Meltzer, et al. CMAJ 1998; 20:S1. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Can J Diabetes. 2008;32(suppl 1):S95.

Microvascular Complications Retinopathy Diabetic eye disease DCCT Type 1 UKPDS Type 2 A1 C reduction 9 7 76 % A1 C reduction by 1% Diabetic kidney disease Neuropathy 54 % 60% 37 % DCCT = Diabetes Control and Complications Trial EDIC = Epidemiology of Diabetes Interventions and Complications Study UKPDS = United Kingdom Prospective Diabetes Study Blood glucose control (measured by A1C) reduces microvascular complications Diabetes Control and Complications Trial Research Group: N Engl J Med 1993;329:977-986. Stratton IM, et al. BMJ 2000;321:405-12.

Targets for Glycemic Control A1C Fasting / preprandial glucose (mmol/l) 2-hr postprandial glucose (mmol/l) Target for most patients 7 % 4.0 7.0 5.0 10.0 (5.0 8.0 if A1C not being met) Treatment goals should be tailored to the individual Incidence of severe hypoglycemia increased 3 fold in the intensive group (DCCT). Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Can J Diabetes. 2008;32(suppl 1):S29-31.

Physiologic Insulin Secretion: 24-Hour Profile GLUCOSE HOMEOSTASIS: Daytime Profile Insulin (mu/l) 8 80 6 4 2 40 Glucose (mmol/l) 0 08.00 13.00 16.00 19.00 h Meal Times Normal Subjects Mean levels 95% CL Owens D, et al. Lancet 2001;358,739-746.

How Do You Mimic Normal Physiology? Use of various insulin formulations Multiple daily injections (MDI) Rigid meal plan to match injected insulin Oral agents in Type 2 DM Use insulin pump for maximum flexibility

What is an Insulin Pump? Programmable, battery-operated device Late 1960ʼs Today Most Recent

What is an Insulin Pump? Mimics pancreas by delivering insulin around the clock with great precision continuous insulin called basal extra insulin for food called bolus Cannula pump tubing Reservoir/cartridge/syringe 1. Chase HP. Diabetes Foundation at Denver 2007. 2. Walsh J, Roberts R. Pumping Insulin 5 th Edition 2012

Approximate Pharmacokinetic Profiles of Human Insulin and Insulin Analogues. Hirsch IB. N Engl J Med 2005;352:174-183.

Single-injection Regimens Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Can J Diabetes. 2008;32(suppl 1):S46-S57.

Split-Mixed Insulin Regimen Traditionally 2/3 of daily dose was given in AM 1/3 of daily dose was given AC supper 2/3 was NPH (intermediate) 1/3 was Regular Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Can J Diabetes. 2008;32(suppl 1):S46-57

Pancreatic Insulin Response vs. Regular Insulin Injection

Basal-Bolus Insulin Therapy: Insulin glargine at bedtime and rapid-acting insulin with meals (can use detemir as basal) Type 1 DM Insulin glargine Insulin gluisine, lispro or aspart B L Time of administration B, breakfast; L, lunch; D, dinner; HS, bedtime. D bedtime Adapted from: 1. Leahy JL. In: Leahy JL, Cefalu WT, eds. Insulin Therapy. New York, NY: Marcel Dekker, Inc.;2002. 2. Bolli GB, et al. Diabetologia. 1999;42:1151 1167.

Factors Affecting the Action of Injected Insulin Formulation Species Site of injection t 1/2 abdomen (87), arm (141), hip (153), thigh (164) minutes for regular insulin day to day variation of 25% in absorption possible when injecting in same area!!! Temperature of insulin Dose Insulin resistance Exercise involving area injected Applied Therapeutics: The Clinical Use of Drugs-LY Young, MA Koda-Kimble, 2003 Walsh, J. Roberts R, Pumping Insulin 5 th Edition, 2012

i-port Advance The first device to combine an injection port and an inserter into one complete set. Indications for use: For use by people requiring multiple daily subcutaneous injections of physician prescribed medications, including insulin Length of soft cannula: Available in 6 mm and 9 mm lengths Residual space of delivery channel: <.0026 ml (0.26 IU) User profile: Adults and children in home and healthcare facilities Needle compatibility: Injection needle should not exceed 8mm in length Septum durability: Up to 75 needle sticks Wear time: Up to 72 hours Packaging: 10 injection ports per box Application Wear Use

Continuous Subcutaneous Insulin Infusion (CSII) with Insulin Pump Bolus given every time food is consumed Basal Provides opportunity for excellent BG control and total flexibility in meal timing with RAPID-ACTING INSULIN FOR BOLUS & BASAL Walsh, J. Roberts R. Pumping Insulin 5 th Edition 2012

Comparison of Pump Therapy & Multiple Doses of Insulin Cost* (excluding insulin or testing) Pump MDI (3+) Pump $6300-$7500 Supplies $150-260/month $40/ month BG testing 4-8 times daily 3-4 times daily Variation in absorptioninsulin Up to 3% Up to 25% when injected in same anatomical area Best A1C 6.3 7.2 Severe Hypoglycemia Less than MDI 22/100 patient yr More frequent as A1C is lowered: 138/100 patient yrs Type of insulin Rapid-acting Rapid/regular + intermediate or glargine or detemir Flexibility/ QOL Excellent Moderate Risk of Ketoacidosis Depends on B/G results and treatments choices Moderate Provincial funding available in some provinces

Difference in A1C Before and After Using an Insulin Pump www.insulin-pumpers.org

Candidates for Pump Therapy Type 1 or Type 2 using insulin Motivated to strive for better control Willing to test BG 3-4 x daily or more learn a new carbohydrate counting method work as part of diabetes care team Wear pump 24/7 Time and patience to learn a new skill Realistic expectations (pump will not make DM go away) Walsh J, Roberts R. Pumping Insulin, 5 th Edition, 2012

Insulin Pumps Currently Available in Canada OneTouch Ping MiniMed Paradigm Veo Accu-Chek Combo Omni-Pod www.diabetesnet.com/diabetes_technology/insulin_pump.models.php

Alerts and Alarms Examples Post-meal reminder alert to test blood glucose Alarm if no bolus given at pre-set time ranges Alert if bolus not completed Occlusion alarm Alert to retest blood glucose after low or high blood sugar reading/treatment Alarm for the next infusion site change Low battery alert Auto-off feature Walsh J, Roberts R. Pumping Insulin, 5 th Edition, 2012.

Programming a Pump Total daily dose (TDD) Basal rates Carbohydrate factor Correction factor Insulin on Board (IOB) Target blood sugar readings for different times of the day Walsh J, Roberts R. Pumping Insulin, 5 th Edition, 2012

Pump Memory Personal settings and pump history are stored in memory Current insulin pumps are linked to blood glucose meters, so that the results of blood sugar are captured into the pump's memory, and can be used to help adjust pump settings Walsh J, Roberts R. Pumping Insulin 5 th Edition, 2012

Paradigm Real-Time: insulin pump & continuous glucose monitoring system Glucose values updated every 5 min Provides time trend graph Time trend arrows Includes bolus wizard calculator Alarms for high or low glucose levels RT results in A1C 0.7% lower over PT w/o RT Does NOT replace finger pokes Most insurance comp. do not cover Cost ~ $65 @ / rated for 6 day usage Time consuming requires frequent calibration 66th Annual Scientific Sessions of the ADA Washington, DC, June 9-13, 2006

What is an Infusion Set? Infusion sets consist of tubing that attaches to the insulin reservoir The infusion set carries insulin to the cannula that is inserted in the subcutaneous tissue The cannula is supported with a plastic hub to the adhesive dressing Site Tubing connector Adhesive tape/pad Cannula http://www.diabetesnet.com/diabetes_technology/infusion_sets.php

Types of Infusion Sets Steel vs Teflon cannula Insertion angle 90º or 30º- 45º Variations in tubing length (45, 60, 80, 110cms) Variations in cannula length 90º range from 5.5mm to 10mm (for varying subcutaneous tissue thickness) 30º- 45º available as 13mm or 17mm Packaged as: complete sets combination sets so tubing changed every other time cannula changed infusion sites only Connection to Reservoir-Luer Lock or Paradigm http://www.diabetesnet.com/diabetes_technology/infusion_sets.php

Infusion Sets Line Pumps -2 types of connections Always ask your client what make & model pump they use Pumps Infusion Sets Luer Lock Pumps Animas- One Touch Ping Medtronic- 507,508 Roche- Accu-Chek Spirit,Combo Cozmo- Deltec Cozmo Cleo 90, Comfort, Comfort Short Tender, Inset II, Inset-30, Orbit 90, Orbit Micro, Quick Set, Rapid D, Ultraflex, Silhouette MiniMed Paradigm MiniMed Paradigm Veo Dedicated connection for all Medtronic Paradigm models Paradigm Silhouette, Paradigm Quickset, Paradigm Sof-Set, Paradigm Sure-T, Paradigm Mio

90 Teflon Cannula Infusion Sets Ultra Flex (Accu-Check) Orbit 90 (Ypsomed) Quick-set (Medtronic) http://www.diabetesnet.com/diabetes_technology/infusion_sets.php

90 Teflon Cannula Infusion sets with Auto-Injector Cleo 90 (Smiths Medical) Inset II (Unomedical) Paradigm Mio (Medtronic) http://www.diabetesnet.com/diabetes_technology/infusion_sets.php

90 Steel Cannula Infusion Sets Orbit Micro (Ypsomed) Rapid D (Accu-Check) Contact Detach (Unomedical) Sure-T (Medtronic) http://www.diabetesnet.com/diabetes_technology/infusion_sets.php

30-45 Teflon Cannula Infusion Sets Tender By Accu- Check Silhouette by Medtronic Minimed Comfort by Unomedical Inset-30 by Unomedical only 30-45º all-in-one http://www.diabetesnet.com/diabetes_technology/infusion_sets.php

Which infusion set to select? Angle of insertion : 90º or angled 30-45º Teflon or stainless steel Auto insertion or manual Luer Lock or Paradigm connection Available as combo packs Tubing length: 45, 60, 80 or 110 cm (18, 24, 30, or 42 inches) Choice is based on user preference Walsh J, Roberts R. Pumping Insulin, 5 th Edition, 2012

Supplies for Insulin Pumpers Infusion sets Reservoirs / cartridges, syringes Coloplast, SkinTac or other skin prep pads Adhesive remover-wipes or liquid Transparent dressings - Tegaderm, IV 3000 by Smith & Nephew Antibiotic ointment Other diabetes supplies - test strips, insulin, glucose tablets, BG meters, ketone testing, etc. Walsh J, Roberts R. Pumping Insulin, 5 th Edition, 2012

Financial Issues Several provinces cover pumps and supplies Private insurance - pump manufacturer will help determine eligibility Financing options through manufacturer Up to 90 day trial period - refund if not satisfied Disability tax credit Cost-benefit (value) of pump therapy

Public Coverage Jurisdiction Insulin pumps for patients under 18 Insulin pumps for patients over 18 yrs Pump supplies BC^ YES+ NO+ YES Alberta YES*?* YES* Saskatchewan^ YES UP TP 25 YRS YES Manitoba YES NO YES Ontario YES YES YES Quebec YES NO YES New Brunswick YES (under 19) NO YES Nova Scotia YES (under 19) NO NO PEI NO NO NO Nfld./Labrador YES UP TO 25 YRS YES NIHB/Territories YES YES YES In almost all cases claims cannot be submitted electronically (exception Claims Secure) ^ pseudo DINs used for submissions

Private Coverage Claim Secure is only company which will electronically bill PINs Infusion Sets 905 454 Reservoirs 905 457 Limited to plans that use Claim Secure and subscribe to this type of coverage Others paid up-front and submitted

Why choose an insulin pump? Quality of life More flexibility of lifestyle; eat, sleep, work, play when you want Better control of diabetes Less low blood sugar reactions Decreased chance of diabetes complications Better management of picky eaters, shift workers, athletes, and the list goes on Walsh J, Roberts R. Pumping Insulin, 5 th Edition, 2012.

Here is What Pumpers Say Allison Type 1 ʻ06, Pumper ʻ09 I've been on the pump for four and a half months now and love it. I would never go back to shots.

Amish Parikh, MD, MEd, FRCPC Type 1 '89, Pumper '02 Insulin pump therapy is very safe. Patients on pump therapy have a better quality of life (as compared to multiple daily injections) and have better overall glycemic control (as measured by HbA1c). These are both achieved with less hypoglycemia. Pump therapy can be fine tuned for the unique needs of each and every patient.

Hands On Practice Learn how to: Fill reservoirs (aka syringes/cartridges) Insert 1. 90 Steel cannula-manual insertion 2. 90 Teflon cannula-auto insertion 3. 30-45 Teflon cannula-manual insertion

Q & A Post hands-on Practice

END ANY QUESTIONS/COMMENTS? PLEASE CONTACT MELANY HELLSTERN melany@insulinpumps.ca 855.608.9100