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Back to the Future! Sarrah Morris BScN, RN, MBA

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Presentation on theme: "Back to the Future! Sarrah Morris BScN, RN, MBA"— Presentation transcript:

1 Back to the Future! Sarrah Morris BScN, RN, MBA
Medtronic Diabetes Canada

2 Disclosure Employed by Medtronic since 2007
Over-bearing Care Partner for 32 years!

3 Excited to be here…. Over-bearing Care Partner Registered Nurse
Worked in acute care settings: Emerg, Congestive Heart Failure, Bone Marrow Transplant Mount Sinai Hospital, Toronto Medtronic Diabetes since 2007

4 Growing up in a T1D household
“Thank you Caregiver!”

5 Today is about YOU and your FAMILY!

6 Objectives Benefits of a pump
The benefits of a pump vs MDI (multiple daily injection) Infusion Sets Basics of Continuous Glucose Monitoring Education and Support 6 6

7 Pumps Lower A1C Better than MDI
Published Meta-analysis 52 studies (1,547 patients) shows pump technology is significantly more effective at lowering A1C than MDI and/or conventional insulin therapy (MD 0.95) Pump MDI Pump MDI * Notes This is a meta-analysis of 52 studies conducted from 1989 to This slide shows just a few of the better known studies that were included in the analysis. This meta-analysis included over 1,500 patients. The overall results are shown here - (pump is in blue and MDI is in gold) you can see that pump technology consistently lowered A1C when compared to MDI. By the way, does anyone here work with pediatric patients? A couple of you - Good. The last three studies on the right side of this slide are pediatric studies. As you can see, the results are consistent whether the patients are adult or pediatric. Bruttomesso D, et al. Diabet Med. 2002;19(8): Bell DSH, et al. Endocr Pract. 2000;6(5): Rudolph DS, et al. Endocr Pract. 2002;8(6): Chantelau E, et al. Diabetologia. 1989;32(7): Boland EA, et al. Diabetes Care. 1999;22(11): Maniatis AK, et al. Pediatrics. 2001;107(2): Litton J, et al. J Pediatr. 2002;141(4): Weissberg—Benchell J et al. Diabetes Care 7 7 7

8 Severe Hypoglycemic Episodes: Pumps vs. MDI
Pumps Reduce Hypoglycemic Events Severe Hypoglycemic Episodes: Pumps vs. MDI Pumps MDI Events /per hundred patient-years * Notes This slide shows the reduction in hypoglycemic events for three of the studies from the meta-analysis. Again, the pump is in blue and MDI is shown in gold. The key take-away from these studies is that the rate of severe hypoglycemia is significantly reduced with insulin pump technolgy. BACKGROUND INFORMATION: RUDOLPH STUDY: With appropriate selection of patients, insulin pump technology is an effective means of treating type 1 diabetes. Pumps improved blood glucose control, decreased occurrence of severe hypoglycemic events, and had a low rate of discontinuation of pump technology. Occurrences of severe hypoglycemia decreased by 73.8% (MDI , Pump – 19.2 (p<0.0001)) BODE STUDY: In this study, patients on long-term pump technology maintained an excellent level of glycemic control and achieved a significant reduction in the rate of severe hypoglycemia relative to the pre-study period of intensive management with MDI therapy. As a mode of insulin delivery in intensive diabetes therapy, Pumps can be used with confidence and success in the private practice setting. Incidence of severe hypoglycemia during MDI declined more than six fold during the first year on pump technology. (MDI – 138 events, Pump – 22 (p<0.0001)) and remained significantly lower in years 2, 3 and 4 on pump technology. BOLAND STUDY: A pediatric study. Pumps are an alternative means to lower A1C levels and reduce the risk of hypoglycemia without adversely affecting psychosocial outcomes in adolescents with type 1 diabetes. A1C after 12 months of treatment: MDI - 8.3%, pump technology – 7.5%. Despite lower A1C levels, patients using pump technology had 50% less severe hypoglycemic events compared to MDI patients (MDI - 134, pump technology I – 76 (p<0.01)). Rudolph JW, Hirsch IB. Assessment of therapy with continuous subcutaneous insulin infusion in an academic diabetes clinic. Endocrine Practice.2002;8(6): Bode, BW, et al. 1996;19: Boland EA, et al. Continuous subcutaneous insulin infusion. Diabetes Care.1999;22: 8

9 Pumps Reduce Severe Hypoglycemia
Published 2008 Pump vs. MDI Severe Hypoglycemia Rate Ratio Study Inclusion Criteria Meta-analysis of 22 studies 10 with children and adolescents 12 studies with adults Compared severe hypoglycemia Type 1 diabetes Duration > 6 months on pump Study Bode (poor control) Bode (good control) Kaderman Maniatis Rizvi Litton Linkeschova Bruttomesso Rudolph, Hirsch Plotnick Cohen Hunger-Dathe Weintrob Weinzimer McMahon Siegel-Czarkowski Alemzadeh Mack-Fogg Sciaffini Rodrigues Lepore Hoogma Overall (I2 = 84.2%, P = 0.00) Results MDI has 4.19 X more severe hypoglycemia than pumps Greatest hypo reduction found in those with highest initial rates of severe hypoglycemia Notes Multiple studies were conducted during the 90’s and early 2000s regarding this comparison. This is a meta-analysis done by J. C. Pickup and A. J. Sutton*. It was published in 2008. The study may (at first) seem difficult to read and interpret – but it is because this was a European study and the incidence of severe hypoglycemia is reported as a ratio – which is not typically how we see it here in the US. Let me see if I can explain what the results of the study were. There were 22 studies that met inclusion criteria, and that criteria was: 1. Randomized controlled trials (RCTs) 2. Minimum of 6 months of pump usage 3. MDI group had severe hypoglycemia frequency > 10 episodes/100 patient years. What the study looked at was how frequently do the MDI patients have hypoglycemia when compared to insulin pump technology patients? Is it 50% more, 100% more? It turned out to be over 400% more. The X axis on this graph represents the ratio of hypoglycemia for MDI vs. Pump. The solid blue line is parity. The average would be here if MDI and Pump had the same rate of hypoglycemia. The rate of MDI hypoglycemia increases as you move to the right. The results basically showed that there were 4.19 times as many severe hypo events for patients using MDI than for patients using pumps. In fact, the hypoglycemia reduction was greatest in those with the highest initial rates of severe hypoglycemia. So the studies indicate that pumps can reduce A1C while reducing severe hypoglycemia at the same time. 0.5 1 2 5 10 25 Favours MDI Favours CSII Pickup JC, Sutton AJ. Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabet Med. 2008;25: 9

10 Is an insulin pump right for you/your child?
Quality of life Fewer injections More flexibility of lifestyle;eat, sleep, play Potential for better control of blood sugar Can lower A1C and reduce low blood sugars Reduced risk of diabetes complications Flexibility for picky eaters, variable activity levels & athletes Variable daily schedules

11 Intensive Insulin Therapies Comparison
Multiple Daily Injections (MDI) 4-6 injections per day of rapid- and long-acting insulin Basal is a fixed dose You must calculate bolus doses based on blood glucose and carbohydrates Insulin Pump Technology Rapid-acting insulin is continuously delivered by the pump Most closely mimics the action of a healthy pancreas Pump calculates bolus doses based on blood glucose and carbohydrates Key Message: Here is an overview of the two intensive therapy treatment options. Background Information: Let’s review this from the last class. The two intensive insulin therapies are: Multiple Daily Injections (MDI), which consists of four to six injections per day; basal is a fixed dose and bolus doses can be calculated based on carbs and blood glucose Insulin Pump Therapy, in which insulin is continuously administered through an insulin pump; the action closely matches that of a healthy pancreas. Multiple daily injections, also referred to as MDI, differs from conventional therapy in that you take a long-acting basal insulin 1 to 2 times per day called Lantus or Levemir, in combination with a rapid-acting bolus insulin (Humalog/Novolog/Apidra) at mealtimes and as needed to correct high glucose levels. Bolus doses are determined for meals by counting carbohydrates and following a mathematical formula. Because everyone’s body reacts differently and insulin itself varies, sometimes your long-acting insulin will not last 24 hours – it may last only 18. Your healthcare provider may break out the dose into two injections and have you take one in the morning and one at night to ensure 24-hour coverage of your basal insulin needs. Because basal insulin is given only once or at most twice a day, it cannot be quickly changed for exercise or other activities that may require more or less basal insulin. Insulin can be continuously administered by insulin pump therapy. The insulin pump stores a 3-day supply of rapid-acting insulin (Humalog/Novolog/Apidra) in a reservoir and is programmed to give a small dose of basal insulin continuously throughout the day and night. At mealtimes, you have to program the insulin pump to give an additional dose of bolus insulin, based upon the amount of food to be eaten. The rapid-acting insulin is used for both the basal insulin and bolus insulin in the pump. The main benefit of an insulin pump is that its actions closely match the actions of a properly functioning pancreas—delivering consistent insulin at a basal rate as well as a bolus dose, with no daily injections. The other major advantage of an insulin pump is that because only rapid-acting insulin is used, the day-to-day variation in insulin absorption is greatly reduced compared to injections of intermediate or long-acting insulins. This can help reduce day-to-day variation in glucose levels and possibly reduce the risk of hypoglycemia and other complications. Insulin pumps also allow flexibility in the timing of meals and other day-to-day events, similar to intensive treatment regimens that combine very-rapid acting and long-acting insulins. This can be of great benefit for people whose schedule varies from one day to the next. And there are no daily injections. Most people who try them get used to insulin pumps fairly quickly and swear they will never go back to injections! Transition: Why should you consider intensive insulin therapy?

12 Insulin Pumps Use Only Rapid-Acting Insulin
Rapid-acting insulin minimizes treatment errors due to pharmacodynamic variability in insulin action* Intermediate-acting insulin Long-acting insulin 46% Rapid-acting insulin 36% 16% Notes Each type of insulin has a unique action time and the time it remains active and peaks is different for each type of insulin. There are long-acting insulins, intermediate-acting insulins and rapid-acting insulins. Furthermore, the pharmacodynamic variability for each insulin type is different. Pharmacodynamic variability is how consistently a one can expect insulin to act upon the body from one patient to the next?    Let’s take a look at the pharmacodynamic variability for each of these insulins. As you can see from this clinical study there is a 46% variation in the effectiveness of intermediate-acting insulin, and 36% variability for long-acting insulin. But, look at the variability for rapid-acting insulin – less than half of the closest – three times much more accurate than intermediate acting insulin. So, even if you are using MDI therapy exactly as directed and you are using an intermediate or a longer-acting insulin such as glargine to cover basal insulin requirements throughout the day, the action is inconsistent enough that every day could be different and it would be hard to know how much is still active and to determine if or how much to give when glucose levels are running high during the day or night. This is simple one of the limitations of longer acting insulin. It just does not behave the same way in the body day after day. Rapid-acting insulin has the lowest intra-patient variability, and it is easier to reproduce similar results day after day. In today’s market, most pump patients use rapid-acting insulin. Rapid-acting insulin has the lowest intrapatient variability *Percentages represent coefficients of variation for insulin action as measured by maximum glucose infusion rate in these euglycemic glucose clamp studies Heinemann L, et al. Diabetes Care.1998;21:1910–1914; Heise T, et al. Diabetes. 2004;53: 12 12

13 Insulin Pumps currently available in Canada
MiniMed® Paradigm® Veo™ by Medtronic MMT 554 & MMT 754 OneTouch® Ping® by Animas Vibe ® by Animas ACCU-CHEK® Combo By Roche Omnipod® by Insulet Tubeless pump

14 INSULIN PUMP TECHNOLOGY AIMS TO MIMIC A HEALTHY PANCREAS
Bolus Insulin Basal Insulin Insulin Time Aims to mimic the pancreas by delivering insulin via continuous insulin called basal insulin extra insulin for food called bolus insulin

15 How Insulin Is Infused Skin Cannula Fat Insulin
Key Message: The insulin pump delivers insulin through this cannula into the fatty tissue. Background Information: First, a needle is used to insert the soft cannula just under the skin, and then the needle is removed. Only the soft cannula remains in your body. {pass around a sample} Once the infusion set is in place, both the basal and bolus insulin doses are delivered slowly in very small increments, allowing the rapid-acting insulin to be absorbed into the fatty tissue as it is being delivered. This helps to decrease the insulin variability that we discussed and improves insulin absorption. For short periods of time, you can disconnect the pump and tubing while leaving the cannula in place for showers, swimming, and other activities. What areas of your body should you use as an infusion site? The abdomen is the most commonly recommended site because insulin is absorbed quickly. However, other parts of the body (arms, thighs, or buttocks) can be used as well. These areas of the body are recommended because they have fewer nerves, and they have a good amount of fat underneath the skin that provides the most consistent rate of absorption of insulin. You may want to experiment to find the most comfortable position for the infusion set. The important thing to remember is to avoid inserting into bony areas or under belt lines and other areas where clothing might cause irritation. If you are using continuous glucose monitoring with your insulin pump, the sensor and infusion set sites should be at least two inches apart. Check with your healthcare provider or diabetes educator about areas that we haven’t discussed here. Some areas may not have enough fat, and other areas may have nerve endings or blood vessels—areas you’ll want to avoid. Transition: It is important to change the infusion set placement. REFERENCE Steil C, Pharmacologic Therapies for Glucose Management. In: Mensing C, ed. American Association of Diabetes Educators. The Art and Science of Diabetes Self-Management Education. 2006; 343.

16 How (Tube) Insulin Pumps Work
Fill reservoir Load reservoir into pump Insert infusion set Change infusion set every 2 to 3 days Key Message: Instead of using a syringe and needle to deliver insulin to your body, the insulin pump delivers insulin into the fatty tissue beneath your skin through a thin, straw-like tube that’s thinner than a piece of spaghetti. This tube connects to the infusion set. Background Information: An infusion set contains a small, flexible cannula (very small, softer tube) that is easily inserted just under the skin. There are a variety of infusion sets available to fit your individual needs. Some sets have very short cannulas for thin people Some sets have longer cannulas that go in at an angle and may be better suited for active people These options enable you to decide what will work best and be the most comfortable. Note that this is the only part of the pump that is actually “attached” to you. So, you can disconnect and reconnect from the insulin pump quickly for activities such as showering, bathing, changing your clothes, intimacy, exercise, or sports, if you like. It is generally recommended to disconnect for only up to one hour at any time. Typically, you’ll wear your infusion set for 2 to 3 days and then replace it with a new one. Maintenance takes only a few minutes and is easy, even for kids. Transition: How does infusion set work? REFERENCES 1 Center for Disease Control (CDC). Toxic-shock syndrome in a patient using continuous subcutaneous insulin infusion pump–Idaho. MMWR Morb Mortal Wkly Rpt. 1983;32(31): ,412. Infusion set attached Pump attached to infusion set OmniPod: you are going to change the pod every 80 hours

17 Basal Insulin Delivers around the clock
Typically start with a single basal rate The basal rate can be adjusted (increased or decreased) You can add additional basal rates The pump can be programmed to deliver higher or lower basal amounts during different periods of the day When rates are set correctly, basal insulin should: Keep your glucose stable between meals and through the night Allows the flexibility to sleep late, eat late, and even skip meals NOTES TO THE PRESENTER: PRESENTER’S NOTES Questions to engage: • Can anyone tell me why you need basal insulin? • What insulin do you take now to meet this insulin need? • Does anyone know why getting basal insulin with the pump can help provide better control? Points to discuss: • Basal insulin is delivered in small, precise amounts around the clock and provides the body with “background” insulin that is needed 24 hours a day. • Basal Insulin replaces the long acting insulin the patient is currently using. • The purpose of basal insulin is to control glucose levels between meals and through the night. • Basal rates can be increased or decreased when needed. Most people start with just one basal rate. When only one basal rate is programmed, it delivers the programmed amount evenly throughout each hour - 24 hours each day.

18 Basal Rates: Deliver 24 Hours / Day
Example of single basal rate 0.50u/hr Pump delivers 0.5 units each hour Basal insulin is divided into unit increments and delivered evenly throughout each hour BASAL RATES Time Rate 12 AM u /hr _____ _________ 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u NOTES TO THE PRESENTER: For instance, if the basal rate is set at 0.5 u/hr the pump will deliver 0.5 u each hour - 24 hours a day. This means the total basal insulin amount that would be delivered over each 24 hour period would equal 12.0 units. This is a “BUILD” slide that will require some practice to learn and use effectively. The purpose of the slide is to provide a visual reinforcement and detailed explanation of how basal insulin is delivered. Begin by explaining that: At first, patient’s typically start with just one, single basal rate When only one basal rate is programmed, it delivers the programmed amount each hour. The basal rate amount is delivered evenly over each hour. Demonstrate using the following example: 1st CLICK: AM Clock presents – highlights 1am to 2am - indicating basal insulin delivery of 0.5 units from midnight to 1am Explain: This means that if they have one basal rate set at 0.5 u/h The pump will deliver exactly 0.5 units from midnight to 1 AM 2nd CLICK: Highlights 1am to 2am indicating basal delivery of 0.5 units And it will deliver exactly 0.5 units from 1am to 2am 3rd CLICK: Presents highlighted segment 2am to 3am - it will deliver 0.5 units from 2am to 3am 4th CLICK: Begins automatic highlighting of each segment – No further clicks required until both clocks are completely highlighted 0.5u 0.5u 0.5u 0.5u AM PM 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u 0.5u 18

19 Insulin Pump Settings Food Correction
Total amount of basal insulin delivered over 24 hours Typically ~40-50% of TDD is basal Total amount of bolus insulin given for food & correction in 24 hours Typically ~ 50-60% of TDD is bolus Food Correction

20 Insulin pumps can reduce some of the burden…

21 Insulin Pump Settings Remaining insulin On board
Remaining insulin: Insulin that remains from previous boluses and has the pharmacodynamic ability to lower glucose. Active Insulin Time: Length of time pump is programmed to track remaining insulin. (example, 2, 3, 4, 5, 6, 7, 8 hrs) Pump subtracts active insulin before calculating a bolus dose for high BGs This helps to prevent insulin “stacking” and the lows that occur from over-correcting highs. Target Range: A range of glucose values that the pump uses to determine if a correction bolus is needed. Can be customized and set for: Pre-meal Target Ranges Post-meal Target Ranges Bedtime Target Range 21

22 Advantages of today’s smart pumps
Calculates bolus amounts using your child’s current: • BG • ICR • ISF • Target Range Benefit: Determines each bolus amount based on patient’s individual pump settings & current needs (BG, carb intake, active insulin) Tracks remaining insulin from previous boluses delivered: Subtracts remaining insulin from the insulin calculated to correct highs, before suggesting total correction amount to take. Benefit: Helps prevent insulin “stacking” & lows that can occur from over correcting if insulin remains from previous boluses Keeps accurate records: Times and values of all BG readings Carbohydrate intake Type, amount, time of boluses Benefit: Provides comprehensive records for therapy evaluation * 22

23 Infusion Sets Steel vs Teflon cannula
Insertion angle 90º or slanted 30º- 45º Variations in length of tubing (45, 60, 80, 110cm) Variations in length of cannula 90º range from 5.5mm to 10mm 30º- 45º available as 13mm or 17mm Packaged as: complete sets combination sets so tubing changed every other time cannula changed Manual insertion vs auto insertion Connection to Reservoir →Luer Lock or Paradigm While trainer makes suggestion, the choice is ultimately up to the user Infusion sets consist of tubing that attaches to the insulin reservoir (also known as a cartridge or syringe) and carries insulin to the cannula (also referred to as the catheter) that is inserted into the subcutaneous tissue. The cannula is supported with a plastic hub or base to the adhesive dressing that keeps the infusion site anchored to the skin. There are two basic categories of infusion sets: those that use a universal Luer-lock system and those that are dedicated to Medtronic’s Paradigm line (models 511 and higher). Numerous styles of infusion sets are available within these two categories. The choice of infusion set is usually determined jointly by the pump trainer and the patient. In choosing an infusion set style, consideration should be given to the following features: Steel versus Teflon Insertion angle Cannula and needle depth Tubing length Packaging options Built in autoinjector References Montopoli T. Pump it up, a pharmacist’s guide to insulin pump therapy. Pharmacy Practice, April/May 2009. Accessed Jan 23, 2010 23

24 What is an infusion set? The connection between the insulin pump and the body At-site disconnection Cannula Housing Insulin Reservoir Adhesive Tape Tubing Cannula Insertion Device One difference with the Pod pump, you can not remove them temporarily

25 Infusion Sets for Tube Pumps: Two different types of connections available
Luer Lock infusion sets (pump specific) Paradigm (not a luer lock connection)

26 Many options for infusion sets; your diabetes educator will help you select the best one for you.
90° Teflon Cannula 30-45°Teflon Cannula 90° Steel Cannula All-in-One 90° Teflon Cannula Infusion Sets with Auto-Injector 26

27 Benefits of Continuous Glucose Monitoring
Continuous BG monitors show trends so that problems can be avoided……. 27

28 CGM Provides Visual Feedback of Glucose Control
Glycemic Variability CGM provides visual feedback to help patients and clinicians understand glucose variability A1C 9 A1c = 9 in both patients Profiles are very different A1C 9 2 different individuals with identical A1c levels; CGM tracings reveal wide glucose fluctuations in 1 and overall High BG readings in the other

29 MiniMed Paradigm VEOTM with Continuous Glucose Monitoring System (CGM)
Low Glucose Suspend Provides time trend graph Alarms for high or low glucose levels RF Linking- Bayer Contour Next Link Meter 29

30 Animas Vibe ® with Dexcom CGM
Colour screen Waterproof at 12 ft for 24 hrs Dexcom G4 CGM technology

31 Product Technical Support
Consider and utilize the many available education resources for patients, parents, caregivers. Product Technical Support Online tools Product technical support 24/7 Replacement pumps Training 4 year pump warranty Travel/vacation pump loaners Therapy software Notes Online tools

32 Dskate 2015: Milton and Montreal 5 day programs
Dskate is a unique combination of elite hockey coaching & Type 1 Diabetes Education For 128 kids aged 7-17 with T1 Diabetes & their parents. Families from New York, Oklahoma City, California, Alaska, Chicago. Florida, and more. Families from 8 Provinces 2 families from Sweden Many diabetes experts who provide education to the kids and parents that include: Dr Mike Riddell, PhD, Exercise and Diabetes expert Dr Bruce Perkins, University of Toronto Michele Sorenson, Psychologist Chris Jarvis, Founder of I Challenge Diabetes And Cory Conacher, Nick Boynton and more. Include pic of educators….

33 Dskate is 2- 5 day programs of Hockey and Diabetes Experiential Learning
128 kids, 170 Parents, 28 Diabetes Educators from across Canada Include pic of educators….

34 My Heroes!

35 Thank you

36 MiniMed® Paradigm® Veo™
Some of the features 2 sizes of pump Bolus Wizard™ calculator Active insulin displayed in 3 locations Continuous Glucose Monitoring (CGM) displayed on screen (when used with sensor) Predictive Alerts Rate of Change Alerts Low Glucose Suspend Wireless communication with Contour Next LINK meter

37 Animas - OneTouch® Ping®
Some of the features Bolus calculator Remote bolus capabilities Wireless communication between pump and meter Waterproof Colour screen on pump Carb database

38 Omnipod Some of the features: Wireless communication btw Pod and
OmniPod PDM (Personal Diabetes Manager) Pod integrates the pumping mechanism, cannula, needle, and insulin reservoir into one wearable unit waterproof Bolus calculator and meter built into PDM

39 Dexcom G4® Stand Alone CGM System
Glucose trends in contrasting colour 20 foot range Custom tones for various alerts 7 day sensors Download data online


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