Significant HbA1c reduction for type 2 diabetes, now clinically proven *

Transcription

1 Insulin Pump Significant reduction for type 2 diabetes, now clinically proven *

2 OpT2mise: a landmark study, showing significant reduction of for T2 diabetes patients using pump * * Reznik Y. Cohen O. Aronson R. et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open label controlled trial. Lancet 204 Volume 84, Issue 9950, P , 4 October 204

3 OpT2mise Study* Clinical Evidence: why pump for T2 diabetes patients T2 Patient profiles Who can benefit from the use of the pump and testimonials from patients achieving Better Control with the pump Pump Convenient Management for T2 CareLink Pro Easy-to-interpret trend reports for glycemic data and behavior patterns Getting2Goal SM A simplified approach to insulin pump therapy for patients with type 2 diabetes * Reznik Y. Cohen O. Aronson R. et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open label controlled trial. Lancet 204 Volume 84, Issue 9950, P , 4 October 204

4 Objective Primary End-point OpT2mise: the largest randomised, controlled study on insulin pump therapy for type 2 diabetes Compare the efficacy and safety of pump therapy and multiple injection therapy in patients with type 2 diabetes who had failed to respond to a basal-bolus regimen after active insulin titration. Between-group difference in mean change in from baseline to 6 months. Pump international centers around the globe 7 6 Design Subjects: adult patients randomized (5-75 years old) 2 Duration: 6 months Patient Population Location: 6 international centers Results delivered with insulin pump Insulin-taking T2 on (> injections/day) 8.0% 2.0% Insulin dose: U/kg/day Mean SMBG 2.5 times/ day Study Schedule Run-in Optimization Randomization Month Study phase 6 months Treatment: Control: Continuation phase 6 months Single Arm Cross to Aronson R, Cohen O, Conget I, et al. OpT2mise: A Randomized Controlled Trial to Compare Insulin Pump Therapy with Multiple Daily Injections in the Treatment of Type 2 Diabetes. Diabetes Technol Ther 204; doi:0.089/dia.20.06

5 OpT2mise: Clinically Proven Better Control for T2 diabetes* insulin pump therapy is clinically proven to reduce * Efficacy.% drop with insulin pump therapy versus a 0.4% in the group on multiple daily injections 0.7 % between groups difference in in favor of insulin pump therapy Mean AC and 95% C.I. (%) Run-in (8 weeks) Baseline 9.0% Week Study Phase (6 months + weeks) 8.6% 7.9% 2x Almost twice as many patients achieve HbAC < 8% with Patients that achieved <8% Patient group on insulin pump therapy insulin pump therapy 55% 28% Patient group on Multiple Daily Injections () * Reznik Y. Cohen O. Aronson R. et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open label controlled trial. Lancet 204 Volume 84, Issue 9950, P , 4 October 204

6 Safety OpT2mise: Clinically Proven Better Control for T2 diabetes* No severe hypoglycemia event with insulin pump therapy and no increase in the time spent in hypoglycemia No ketoacidosis events with insulin pump therapy 20% total daily insulin dose reduction with insulin pump therapy when compared with Other results 8% increase of HDL-cholesterol concentration with insulin pump therapy and 7% decrease in the group No significant difference in body weight change with insulin pump therapy * Reznik Y. Cohen O. Aronson R. et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open label controlled trial. Lancet 204 Volume 84, Issue 9950, P , 4 October 204

7 Treatment satisfaction** OpT2mise: Clinically Proven Better Control for T2 diabetes* Patients using Pump therapy reported increased satisfaction of diabetes treatment with significant improvements in: treatment convenience flexibility understanding of diabetes willingness to recommend the treatment satisfaction to continue treatment p<0.05 p<0.000 p<0.000 p<0.05 p<0.000 p<0.000 p<0.000 NS 2 0 Overall Satisfaction Treatment convenience Flexibility Understanding of diabetes Willingness to Recommend the Treatment Satisfaction to Continue the Treatment Perceived Hyperglycemia Perceived Hypoglycemia Scale 0 to 6 * Reznik Y. Cohen O. Aronson R. et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open label controlled trial. Lancet 204 Volume 84, Issue 9950, P , 4 October 204 ** OpT2mise study: The Impact of Insulin Pump Therapy on Treatment Satisfaction and Resource Utilization in Patients with Type 2 Diabetes Aronson et al.

8 Potential long term benefit OpT2mise: Clinically Proven Better Control for T2 diabetes* Reducing is critical for people with diabetes..% drop in is associated with significant reduction in diabetes related complications such as eye disease, kidney disease, nerve damage and heart attacks **,*** 0 Microvascular Any Endpoint Related to Diabetes Death Related to Diabetes Fatal and Non-fatal Myocardial infarction Amputation or Death from peripheral vascular disease 0 Risk Reduction (%) % -2% -2% -4% 50 UKPDS: United Kingdom Prospective Diabetes Study. -4% * Reznik Y. Cohen O. Aronson R. et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open label controlled trial. Lancet 204 Volume 84, Issue 9950, P , 4 October 204 ** UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complication in patients with type 2 diabetes (UKPDS ). lancet 998; 52:87-85 ***The post trial monitoring results: 0 years follow up: Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HAW. 0-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 59:

9 Patient clinical profile: OpT2mise*: which T2 patients could benefit from Insulin Pump Therapy? Patient behavioral parameters: between 8%-2% Insulin requirements of U/kg Multiple daily injections therapy (+ injections per day) with or without combination with other oral or non-insulin injectable agents. Facing challenges to meet goals despite dosing titrations over at least the last months. Patient shows dissatisfaction and/or difficulty adhering to current medication regimen He/She has an active life and finds it difficult to fulfill the requirements of He/She often forgets to bolus at meals and can t follow a regular diet regimen He/She is motivated and willing to monitor blood glucose since concerned about long term complications In the OpT2mise study, older age, longer duration of diabetes, low cognitive score and low SMBG use did not diminish the positive effect of therapy** * Reznik Y. Cohen O. Aronson R. et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open label controlled trial. Lancet 204 Volume 84, Issue 9950, P , 4 October 204 ** Factors associated with successful continuous subcutaneous insulin infusion therapy in type 2 diabetes patients - the OPT2MISE trial - Cohen at al.

10 Mark Male 52 BMI, overweight T2 diabetes, in regimen : 9% TDD: 02 units Duration of diabetes: 8 years Comorbidities: - hypertension - hyperlipedemia - smoking Lifestyle profile and challenges in managing diabetes with He has high insulin requirements. Large boluses oftentimes result in painful injections He does not have a standard schedule for his meals. Sometimes he forgets to bolus and this results in hyperglycaemic events He spends most of his day on the go. His job brings him to be always surrounded by people: does not always provide discretion or an ideal solution 20 % * Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. How the pump can help 00 units reservoirs: practical and easy change every days. 75 units of Max Bolus Missed Meal Bolus Reminder featured in the pumps can ensure he is not missing meal insulin pump enables discreet Bolusing through a simple button push, everywhere and in every situation More than 20% of people taking insulin with admit that injections interfere with their daily life, creating anxiety and discomfort. * Diabetes Care, 200 Feb;(2):240-5

11 Catherine Female 55 BMI 2, overweight T2 diabetes, in regimen : 0.2% TDD: 96 units Duration of diabetes: 6 years Lifestyle profile and challenges in managing diabetes with She has needle phobia and she experiences pain at injection. This leads her to skip some injections, especially when she has small snacks How the pump can help Insulin pump users only insert their infusion set once every 2 to days Meal time insulin is delivered painlessly and discreetly with a few simple button presses Comorbidities: - obesity - hypertension - mild stable coronary heart disease - dislipidemia - diabetic rethinopaty - albuminuria 57 % She is concerned about being able to stay in good health for her family The reduction achieved by pump therapy means that your patients can have a significantly reduced occurrence of long term complications of people taking insulin with openly admit to omittinginsulin injections. * * Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care, 200 Feb;(2):240-5

12 Janis IN BETTER CONTROL WITH MINIMED PUMP SINCE 2009 Meet Janis and John, two Type 2 Diabetes patients that achieved Better Control with their Pump The pump has been wonderful for me. It keeps my numbers down and I can do whatever I want to do. It gives me freedom and better control My glycated hemoglobin has improved. Today, on pump therapy, is 6.4%. It was 9.% on multiple daily injections 2009 I am in better control with my pump since 2009, when I made the switch from multiple daily injections

13 John What I ve told people who are considering switching to an insulin pump is that it s a move that I ve never regretted. I feel like I ve got far more control using the pump than I ever did by using the multiple daily injections. - John You don t have the embarrassing or clumsy moments of doing injections in front of others or dismissing yourself to go take an injection. - John IN BETTER CONTROL WITH MINIMED PUMP SINCE Using the pump has allowed me to get tighter control of my blood glucose levels with less interaction in dealing with taking multiple daily injections and oral medications My glycated hemoglobin has improved. Today, on pump therapy, is between the range 6.2% - 7.2%. It was 9.2% on multiple daily injections. I have reduced my daily insulin intake to 70 units. It was 220 units on multiple daily injections I am in better control with my pump since 20, when I made the switch from multiple daily injections

14 Why 640G Insulin pump: Convenient Management for T2 For over 25 years, Medtronic has offered products with unique features and support, confirming leadership in innovation in insulin pump therapy and integrated system and always having the patients needs as first priority. 640G Customer support and service to help improve the quality of your practice and outcomes for your patients. Education and training programs for patients and HCPs. CareLink : CareLink Pro provides easy-to-interpret trend reports for glycemic data and behavior patterns. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use

15 640G Insulin pump: Convenient Management for T2 Customizable pump features to keep it simple for your type 2 patients 640G features to adapt to T2 diabetes therapy HIGH INSULIN NEEDS With ml/00 units capacity, usage of insulin reservoir is maximized and changes minimized. Max bolus of 75 units to meet also high insulin needs combined with High bolus speed (5 units/minute. Max bolus delivered in 5 minutes) Multiple basal rates to best meet their insulin needs NEED FOR SIMPLICITY & SUPPORT Up to 8 Preset Bolus amounts, easy to access and deliver The Missed Meal Bolus Reminder will help to ensure that your patients don t miss a dose. NEED FOR CONVENIENCE AND DISCRETION Possible to deliver an insulin bolus discreetly from Bayer Contour Next LINK 2.4 meter Volume adjustable for alarms and vibration mode available Full color screen Self adjusting display that adapt to light If your patient suffers from DEXTERITY IMPAIRMENT, this feature could be useful Key pad with tactile recognizable button and usable by both right and left handed pump therapy can help reduce patients anxiety to insulin taking This can improve their adherence to therapy. Only 0 to 2 infusion sets changes instead of up to 20 /50 injections per month Meal time insulin is delivered painlessly and discreetly with a few simple button pushes or remotely using the Bayer Meter. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use

16 CareLink Pro reports Number of BG Readings Number of Bolus Events Look for skipped boluses before each meal. Fill Events Frequency of rewind, cannula and tubing fill to assess proper infusion set changes. Suspend Duration of Insulin Delivery Glucose Measurements Bolus Events Fill Events BG Readings Sensor Duration (h:mm) Manual Boluses Bolus Wizard Events With Food With Correction Overridden Rewind Cannula Fills Cannula Amount (U) Tubing Fills Tubing Amount (U) Suspend Duration (h:mm) Sunday 4//202 Monday 4/2/ Tuesday 4// CareLink Therapy Management Software organizes pump and BG meter data into meaningful reports to review the cause and effect relationship between insulin, food, exercise and how patient behaviors impact BG control. Upload pump at the beginning of the visit and review reports during the visit. Adherence Report Provides insights into a patient s self-management behaviors and helps confirm optimal device use. Use the guidelines below to assess patient behaviors and adherence. Wednesday 4/4/202 Thursday 4/5/202 Friday 4/6/202 Saturday 4/7/202 Sunday 4/8/202 Summary 2./day GOOD IF: SUBOPTIMAL IF: 0m /day 0.0/day 2 /day boluses/day <2 BG/day <, assess causes (e.g., forgets to bolus or skipping meals) U /fill Prime every 2 days, more frequent with high TDD. At each set change, should see rewind, cannula, tubing fill. Prime < per 2 days => extended use of infusion sets U/fill 0m Blank or short duration suspends > 2 hours/day, assess reasons (e.g. low BG) THIS EXAMPLE: Patient is doing 2 BG/day Patient is bolusing for all the main meals Patient is compliant with infusion set change Patient did not suspend

17 CareLink Pro reports Sensor & Meter Overview The 24 hour glucose overlay report displays hourly meter glucose values and glycemic excursions and patterns. BG data will be displayed by an RF linked meter or by uploading the appropriate BG meter to CareLink. Device Settings Snapshot An easy way to view pump settings (i.e., dosages). Report can be added to patient s chart to track changes in settings from visit to visit. _ Review average TDD, daily basal vs. bolus (%) 2 _ Review BG readings above/below target _ Identify whether there are trends or patterns 84% of BGs are high Displays patient s basal rates at the time device was uploaded 24-Hour Meter Glucose Overlay - Readings & Averages (mg/dl) 2 Statistics Avg BG (mg/dl) BG Readings Readings Above Target 0/25 - /8 207 ± /day 5 84% Device Settings Snapshot Thursday 6/0/20 8:4 AM Readings Below Target Sensor Avg (mg/dl) Avg AUC > 40 (mg/dl) Avg AUC < 70 (mg/dl) Avg Daily Carbs (g) 0% Basal Maximum Basal Rate Temp Basal Type Standard (active) 4.00 U/hr Percent of Basal Pattern A Pattern B Bolus Maximum Bolus Dual/Square (Variable) Blood Glucose Reminder 25.0 U Off Off Carbs/Bolus Insulin (g/u) Avg Total Daily Insulin (U) Avg Daily Basal (U) Avg Daily Bolus (U) 80. ± % 5% 24-Hour Total TIME 0:00 :00 :0 6: U U/hr Hour Total TIME :0 5:00 8:00 U/hr Hour Total TIME :00 4:0 6:0 U/hr Easy (Audio) Bolus Entry (Step) Bolus Wizard Units Active Insulin (h:mm) Insulin Concentration On.00 U Off g, mg/dl Missed Bolus Reminder Start (h:mm) Off End (h:mm) Glucose Alerts TIME 0:00 6:00 22:00 On Low (mg/dl) (m High BG throughout Basal/bolus ratio: 47%/5% THIS EXAMPLE SHOWS: Doses are OK (47% basal/5% bolus) 2 Generally high (84% high). From the data, discuss with patient to assess/identify potential causes. Consider:. Increasing basal rate; 2. Consider dietary causes;. Ask patient to do post-prandial BG 8:0 6:00 9:00 22: : :0 9: Carbohydrate Ratio (g/u) TIME Insulin adjustments can be written directly on the form and put in chart. Ratio Insulin Sensitivity (mg/dl per U) TIME Sensitivity Blood Glucose Target (mg/dl) TIME Low High Alert Repeat Predictive Alert Low High (mins) Rate Alert: Fall Rise (mg/dl/min) On 0: Notes

18 Getting2Goal Type 2 Diabetes Pumping Protocol Calculate Starting Dose INJECTION DOSE METHOD WEIGHT METHOD Example Sum up ALL current daily insulin injection doses OR Take current weight in kg ( lb = 0.45 kg) Type 2 Patient: 85 kg = 9.5% Takes all insulin injections. Eats similar-sized meals. Multiply by 0.8 to.0 0.8: Nonadherent with dosing, 7-9%.0: Adherent with dosing, > 9% PUMP TOTAL DAILY DOSE (TDD) Multiply by 0.5 to units/kg/day 0.5: Normal build, at risk of hypoglycemia 0.7: Overweight, insulin resistant.0: Obese, very insulin resistant, > 9% INJECTION DOSE METHOD (units/day) 20 units x (rapid acting) + 46 units (glargine) at bedtime = 06 units/day Multiply by.0 No reduction because patient is taking all their insulin doses and > 9%. 50% 50% PUMP TOTAL DAILY DOSE (TDD) = 06 units/day TOTAL DAILY BASAL DOSE TOTAL DAILY BOLUS DOSE 50% 50% Divide by 24 Divide by Meal Bolus may be adjusted for portion size (Large, Medium, Small). Total Daily Basal = 06 units/day x 0.5 = 5 units/day Total Daily Bolus = 06 units/day x 0.5 = 5 units/day HOURLY BASAL RATE (units/hr) BOLUS/MEAL (units/meal) Hourly Basal Rate = 5 units/day 24 hrs = 2.2 units/hr Bolus per Meal = 5 units/day = 8 units/meal While every reasonable precaution has been taken in the preparation of this guide, the author, sponsor and publisher assume no responsibility for errors or omissions, nor for the uses made of the materials contained herein and the decisions based on such use. This document does not contain all of the information necessary for the proper care and treatment of patients with diabetes. As such, no individual may rely on the information presented herein in forming a comprehensive treatment program or in treating any patient with diabetes. No warranties are made, expressed or implied, with regard to the contents of this work or to its applicability to specific patients or circumstances. Neither the author, sponsor, nor the publisher shall be liable for direct, indirect, special, incidental or consequential damages arising out of the use or inability to use the contents of this guide.

19 Getting2Goal Type 2 Diabetes Pumping Protocol Initiation of Pump Therapy. Instruct patient not to take premix, intermediate, long acting insulin injection the day of the pump start Upon completion of pump training, ask patient to do a BG. If BG 200 mg/dl, start full pump basal. If BG< 200 mg/dl or patient was on long acting insulin and took a bedtime insulin dose or morning dose, program a temporary basal rate of 50% for 8 0 hours. 2. Adjust other glucose lowering medications Stop sulfonylureas and meglitinides. Continue metformin and consider continuing incretin mimetics, insulin sensitizers and other glucose lowering agents. Once at goal, consider discontinuing medications one at a time to determine if BG control can be maintained. Consider discontinuing TZD if patient has edema or weight gain.. Change in insulin requirements Expect reduction in insulin requirement as a result of improvement in lipotoxicity and glucotoxicity. If no change in insulin requirements and suboptimal glucose control: Consider reinforcing lifestyle changes (i.e., exercise and decreased calorie consumption). While every reasonable precaution has been taken in the preparation of this guide, the author, sponsor and publisher assume no responsibility for errors or omissions, nor for the uses made of the materials contained herein and the decisions based on such use. This document does not contain all of the information necessary for the proper care and treatment of patients with diabetes. As such, no individual may rely on the information presented herein in forming a comprehensive treatment program or in treating any patient with diabetes. No warranties are made, expressed or implied, with regard to the contents of this work or to its applicability to specific patients or circumstances. Neither the author, sponsor, nor the publisher shall be liable for direct, indirect, special, incidental or consequential damages arising out of the use or inability to use the contents of this guide.

20 Getting2Goal Type 2 Diabetes Pumping Protocol Adjust Pump Settings. For initial pump adjustments (Week 2), ask patient to take 4 BGs/day ( pre-meal + bedtime) 2. Adjust settings when 2 out of days of BG are outside BG targets BG targets 8 : Pre-meal 70 0 mg/dl, post-prandial peak <80 mg/dl, Bedtime mg/dl. Consider individualizing BG targets if there are concerns about hypoglycemia.. Adjust pump settings in this order: A B C Overnight Basal If bedtime (HS) BG is in target, pre-breakfast BG > target, increase overnight basal by 0 20% from 2am to 8am. If bedtime (HS) BG is in target, pre-breakfast BG < target, decrease overnight basal by 0 20% from 2am to 8am. If bedtime is high, consider increasing dinner bolus before making overnight basal changes. Daytime Basal If all pre-meal and bedtime BG > target, increase basal 0 20% from 8am 2am. If all pre-meal bedtime BG < target, decrease basal 0 20% from 8am 2am. If patient is willing to delay or skip a meal, consider doing a daytime basal test. Have patient test BG every 2 hours to make sure BG is stable in the absence of food. Bolus If pre-meal BG > target, increase prior meal bolus 0 20%. If premeal BG < target, decrease prior meal bolus 0 20% While every reasonable precaution has been taken in the preparation of this guide, the author, sponsor and publisher assume no responsibility for errors or omissions, nor for the uses made of the materials contained herein and the decisions based on such use. This document does not contain all of the information necessary for the proper care and treatment of patients with diabetes. As such, no individual may rely on the information presented herein in forming a comprehensive treatment program or in treating any patient with diabetes. No warranties are made, expressed or implied, with regard to the contents of this work or to its applicability to specific patients or circumstances. Neither the author, sponsor, nor the publisher shall be liable for direct, indirect, special, incidental or consequential damages arising out of the use or inability to use the contents of this guide. If unable to determine correct bolus dose using pre-meal BGs, ask patient to take.5 2 hour post-meal BG. Adjust bolus dose meal at a time - If post-meal (.5 hr 2 hr) BG target, increase bolus 0 20%. If post-meal BG < target, decrease bolus 0 20%. UC205028EE 204 Medtronic, Inc. All Rights Reserved. Printed in Europe.