Getting2Goal SM Type 2 Diabetes Pumping Protocol

Transcription

1 MiniMed for TYPE DIABETES GettingGoal SM Type Diabetes Pumping Protocol A simplified approach to insulin pump therapy for patients with type diabetes

2 With guidance from: Bruce W. Bode, MD, FACE Bruce Bode, MD is a Clinical Associate Professor of Medicine at Emory University in Atlanta, Georgia. He is an internationally known speaker and author on insulin pump therapy and continuous glucose monitoring. Professor Ohad Cohen Ohad Cohen, MD is an Associate Professor of Medicine at the institute of Endocrinology at the Ch. Sheba Medical Center and Sackler School of Medicine, Tel-Aviv University, Israel. He is active in promoting better care of diabetes with the use of technology through research and education of health care providers and patients. He is also Director of Medical Affairs for Medtronic Diabetes Western Europe and Canada. Scott Lee, MD Scott Lee, MD, is an Associate Professor of Medicine and former Medical Director of the Diabetes Treatment Center at Loma Linda University Medical Center in Loma Linda, California. He is also the Medical Director of Global Clinical Research and Medical Affairs for Medtronic Diabetes. Contents Purpose Patient Selection Calculate Starting Dose Initiation of Pump Therapy Adjust Pump Settings Assessing Unexplained High Glucose 4 Treatment of Hypoglycemia 4 Type Insulin Pump Initiation Settings Form CareLink Pro Reports 6 Type Insulin Pump Tips and Detailed Follow Up Plan 8 Purpose The GettingGoal SM Type Pumping Protocol is a stepwise approach to prescribing and managing insulin pump therapy for type patients. This simple approach, can help the patient transition from injections to pump therapy. This booklet includes information on patient selection, guidelines for initiating and fine-tuning pump settings, optimization with CareLink software and ongoing management. Patient Selection: Who is a type insulin pump candidate for GettingGoal SM? Professor Yves Reznik Yvez Reznik, MD, is a Professor of Endocrinology, Diabetes and Metabolic Diseases at Caen University, Normandie, France. He is active in the field of Diabetes Technologies and has an extensive experience with the management of insulin pump in type diabetes. Insulin requiring type patients -6 on daily injections sub optimally controlled with optimum injection regimen and CLINICAL CRITERIA HbAc > 8% Suboptimal glycemic control High insulin requirements Recurrent hyperglycemia/ high glucose excursions Overweight/obese PATIENT PREFERENCES AND NEEDS Fewer injections Discreet, convenient, ease of delivery Lifestyle flexibility Achieve HbAc goals Improve adherence to management plan 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. PATIENT CRITERIA: Willing to monitor at least BG/day routinely Capable of using simple technology, e.g., cell phone/calculator Willing to try alternative method of insulin delivery Have sufficient vision or hearing to allow recognition of the pump signals and alarms * Latent Autoimmune Diabetes in Adults (LADA) is often misdiagnosed as type. These patients demonstrate characteristics of both type (autoimmunity) and type (adult-onset and initial control with OAD) diabetes and progress to insulin dependency more quickly than type patients. 7 If you suspect a patient may be LADA, perform a GAD testing to confirm. NOTE: This approach is not intended for the intensive management that is needed for most type and LADA* patients and pregnancy management.

3 Calculate Starting Dose 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 00 mg/dl, start full pump basal. If BG< 00 mg/dl or patient was on long acting insulin and took a bedtime insulin dose or morning dose, program a temporary basal rate of 0% for 8 0 hours. INJECTION DOSE METHOD WEIGHT METHOD Sum up ALL current daily insulin injection doses OR Take current weight in kg ( lb = 0.4 kg). Adjust other glucose lowering medications Stop sulfonylureas and meglitinides. Multiply by 0.8 to.0 0.8: Nonadherent with dosing, HbAc 7-9%.0: Adherent with dosing, HbAc > 9% Multiply by 0. to units/kg/day 0.: Normal build, at risk of hypoglycemia 0.7: Overweight, insulin resistant.0: Obese, very insulin resistant, HbAc > 9% 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. PUMP TOTAL DAILY DOSE (TDD) 0% 0%. Change in insulin requirements Expect reduction in insulin requirement as a result of improvement in lipotoxicity and glucotoxicity. TOTAL DAILY BASAL DOSE TOTAL DAILY BOLUS DOSE If no change in insulin requirements and suboptimal glucose control: Consider reinforcing lifestyle changes (i.e., exercise and decreased calorie consumption). Divide by 4 HOURLY BASAL RATE (units/hr) Divide by Meal may be adjusted for portion size (Large, Medium, Small). BOLUS/MEAL (units/meal) Adjust Pump Settings Example Type Patient: 8 kg HbAc = 9.% Takes all insulin injections. Eats similar-sized meals. INJECTION DOSE METHOD (units/day) 0 units x (rapid acting) + 46 units (glargine) at bedtime = 06 units/day. For initial pump adjustments (Week ), ask patient to take 4 BGs/ day ( pre-meal + bedtime). Adjust settings when 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: NOTE: Consider using the weight method if bolus to basal ratio of the patient s pre-pump total daily injection dose is significantly different from 0:0 (e.g., bolus/ total dose = 60%) Multiply by.0 No reduction because patient is taking all their insulin doses and HbAc > 9%. PUMP TOTAL DAILY DOSE (TDD) = 06 units/day Total Daily Basal = 06 units/day x 0. = units/day Hourly Basal Rate = units/day 4 hrs =. units/hr 0% 0% Total Daily = 06 units/day x 0. = units/day per Meal = units/day = 8 units/meal A B C Overnight Basal If bedtime (HS) BG is in target, pre-breakfast BG > target, increase overnight basal by 0 0% from am to 8am. If bedtime (HS) BG is in target, pre-breakfast BG < target, decrease overnight basal by 0 0% from am 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 0% from 8am am. If all pre-meal bedtime BG < target, decrease basal 0 0% from 8am am. If patient is willing to delay or skip a meal, consider doing a daytime basal test. Have patient test BG every hours to make sure BG is stable in the absence of food. If pre-meal BG > target, increase prior meal bolus 0 0%. If premeal BG < target, decrease prior meal bolus 0 0% If unable to determine correct bolus dose using pre-meal BGs, ask patient to take. hour postmeal BG. Adjust bolus dose meal at a time - If post-meal (. hr hr) BG target, increase bolus 0 0%. If post-meal BG < target, decrease bolus 0 0%. NOTE: Adjust no more than settings at a time. If BG is low (<70 mg/dl), instruct patients to treat immediately. Fine tuning of pump settings is best accomplished if patient does more BG testing. Refer to the Forms section for a detailed example of pump setting adjustments.

4 Assessing Unexplained High Glucose WHAT TO CHECK QUESTIONS TO ASK IF YES Infusion site Is it red, irritated or painful? Is it wet, or does it smell like insulin? Do you suspect an infection? Change infusion set, reservoir and insulin Treat infection as indicated Type Insulin Pump Initiation Settings Form Prescriber s Instructions to Type Patient HbAc: Patient Name: Weight: Height: BMI: DOB/Age: Current Insulin Regimen Premix ( or /day) Basal: Lantus / Levemir / NPH /Humulin N : Humalog / Novorapid (Novolog) / Apidra Pre-Pump Total Daily Dose (TDD) Total Morning Bedtime Breakfast: Lunch: Dinner: Basal + = Infusion set tubing Are there bubbles (larger than champagne bubbles) in the tubing? Change infusion set, reservoir and insulin units units am units HS units units units units/day Is there blood in the tubing? Pump TDD (select ONE of the following) Connection between reservoir and infusion set Are there leaks/breaks? Is connection loose/easily moved? Change infusion set, reservoir and insulin if unable to correct the problem by tightening Injection Dose Method 0.8: Nonadherent with dosing, HbAc 7 9%.0: Adherent with dosing, HbAc >9% Pump TDD = units/day x = units/day OR Weight Method 0.: Normal build, at risk for hypoglycemia 0.7: Overweight, insulin resistant.0: Obese, very insulin resistant, HbAc >9% Pump TDD = kg x units/kg/day = units/day Prepump TDD Patient weight 0..0 Reservoir Is it loaded incorrectly? Is the reservoir empty? Are there excessive bubbles? Change infusion set, reservoir and insulin if unable to correct the issue Basal Rate (hourly) Dose (per meal) Total Daily Basal = x 0% = units/day Total Daily = x 0% = units/day Pump TDD % Basal Pump TDD % Hourly Basal Rate = units 4 hrs = units/hour Dose/Meal = units = units/meal Insulin Has insulin vial expired? Has insulin been exposed to high temperatures or direct sunlight? Change infusion set and reservoir using a new vial of insulin. (When in doubt, change it out!) Total Daily Basal Total Daily If portion size varies, modify doses to fit patient s diets and habits Breakfast: Lunch: Dinner: Snack: Units: CHECK INSULIN PUMP SETTINGS ON PUMP SCREEN OR CARELINK PRO REPORT Medication Adjustment Checklist Delivery Was last meal bolus missed? Remind patient to take meal bolus. Retrain on easy bolus or missed bolus reminder. STOP: Premix/intermediate/long-acting insulin day of pump start CONSIDER STOPPING: YES NO Sulfonylureas (Amaryl) CONTINUE: Metformin. CONSIDER CONTINUING: YES NO Incretin mimetics (GLP) Basal Rates Time Are basal rates set incorrectly? Is time (AM/PM) set correctly? Reset basal rates Set time correctly Meglitinides (Prandin) Insulin sensitizer (TZD) Incretin enhancers (DPP-4) BG Targets Insulin pump Is insulin pump not working or inoperable? Call the Medtronic Diabetes HelpLine ADA BG Targets (Pre-prandial 70 0 mg/dl, post-prandial <80 mg/dl, bedtime mg/dl) Fasting/Pre-prandial to mg/dl Post-prandial mg/dl Bedtime (HS) to mg/dl Pump Adjustments: Make adjustments when out of days of BG are outside these ranges Treatment of Hypoglycemia A common problem in diabetes is over-treating hypoglycemia, which causes hyperglycemia. To help patients prevent this, ask them to follow the Rule when BG falls below 70 mg/dl. RULE. Overnight Basal. Daytime Basal. Dose. If pre-breakfast BG > 0, increase overnight basal 0 0% (am 8am). If pre-breakfast BG < 70, decrease overnight basal 0 0% (am 8am). If all pre-meal BG > 0, increase basal 0 0% (8am am). If all premeal BG < 70, decrease basal 0 0% (8am am) Notes. If next period pre-meal BG > 0, increase prior meal bolus 0 0%. If next period pre-meal BG < 70, decrease prior meal 0 0%. If post-meal (. hr hr) BG 80, increase bolus 0 0%. If post-meal BG < 70, decrease bolus 0 0% Consume grams of a fast-acting carbohydrate. Recheck BG in minutes. These instructions shall be valid for 6 months unless otherwise specified here: months. If BG < 70 mg/dl, repeat steps one and two until BG returns to normal range. (If BG is < 0 mg/dl, patient can start treatment with 0 grams). Prescriber Name: Signature: Date: Call your physician or health care provider for severe low BG. Call Medtronic for technical issues.

5 CareLink Pro Reports 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. Sensor & Meter Overview The 4 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. _ Review average TDD, daily basal vs. bolus (%) _ Review BG readings above/below target _ Identify whether there are trends or patterns 84% of BGs are high Sensor & Meter Overview ( of ) Generated: 8/6/0 :4:4 PM Page of Data Sources: Ascensia CONTOUR 0//0 - /8/0 4-Hour Meter Glucose Overlay - Readings & Averages (mg/dl) Statistics 0/ - /8 Avg BG (mg/dl) 07 ± 66 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. BG Readings Readings Above Target Readings Below Target Sensor Avg (mg/dl) Avg AUC > 40 (mg/dl) Avg AUC < 70 (mg/dl) Avg Daily Carbs (g) 6 4./day 84% 0% Carbs/ Insulin (g/u) Avg Total Daily Insulin (U) 80. ±. Number of BG Readings Number of 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 Avg Daily (U) 84.0 % Meter Glucose Overlay Bedtime to Wake-Up and Meal Periods Readings & Averages (mg/dl) Bedtime to Wake-up Breakfast: 6:00 AM - 0:00 AM Lunch: :00 AM - :00 PM Dinner: 4:00 PM - 0:00 PM Meals Analyzed: 0 Meals Analyzed: 0 Meals Analyzed: 0 Bedtime: 8:00 PM - :00 AM Wake-up: :00 AM - 9:00 AM Avg Carbs: Avg Carbs: Avg Carbs: High BG throughout Basal/bolus ratio: 47%/% Avg Insulin: Avg Insulin: Avg Insulin: Avg Carbs/Insulin: Avg Carbs/Insulin: Avg Carbs/Insulin: Avg Daily Basal (U) % Glucose Measurements Sensor BG Duration Readings Events Manual es Wizard Events With Food With Correction Overridden Fill Events Rewind Cannula Fills Cannula Amount (U) Tubing Fills Tubing Amount (U) Suspend Duration THIS EXAMPLE SHOWS: Doses are OK (47% basal/% bolus) Generally high (84% high). From the data, discuss with patient to assess/ identify potential causes. Consider:. Increasing basal rate;. Consider dietary causes;. Ask patient to do post-prandial BG Sunday 4//0 0.6 Monday 4//0 4 BG reading BG reading Off chart Average within target range Average outside target range Tuesday 4//0 Wednesday 4/4/0 Thursday 4//0 Friday 4/6/ 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. Saturday 4/7/ Sunday 4/8/0 Summary./day 0m.8/day 0.0/day 0.U /fill.8u/fill 0m Displays patient s basal rates at the time device was uploaded Device Settings Snapshot Thursday 6/0/0 8:4 AM Basal Sensor Maximum Basal Rate 4.00 U/hr Maximum.0 U Temp Basal Type Percent of Basal Dual/Square (Variable) Off Standard (active) Pattern A Pattern B Blood Glucose Reminder Off GOOD IF: SUBOPTIMAL IF: /day boluses/day < BG/day <, assess causes (e.g., forgets to bolus or skipping meals) Prime every days, more frequent with high TDD. At each set change, should see rewind, cannula, tubing fill. Prime < per days => extended use of infusion sets Blank or short duration suspends > hours/day, assess reasons (e.g. low BG) 4-Hour Total 0:00 :00 :0 6:00 8:0 6:00 9:00 : U U/hr Hour Total :0 :00 8:00 8:00 U/hr Hour Total :00 4:0 6:0 :0 9:00 U/hr Easy (Audio) On Entry (Step).00 U Wizard Off Units g, mg/dl Active Insulin Time Insulin Concentration Carbohydrate Ratio (g/u) Ratio Insulin Sensitivity (mg/dl per U) Sensitivity Missed Reminder Start Blood Glucose Target (mg/dl) Off End Low High Glucose Alerts 0:00 6:00 :00 On Low (mg/dl) High (mg/dl) Alert Repeat 0:0 :0 THIS EXAMPLE: Patient is doing BG/day Patient is bolusing for all the main meals Patient is compliant with infusion set change Patient did not suspend Insulin adjustments can be written directly on the form and put in chart. Predictive Alert Low High (mins) On Rate Alert: Fall Rise (mg/dl/min) Notes

6 4 - Type Insulin Pump Tips and Detailed Follow Up Plan GettingGoal is a simple, stepwise approach to pump therapy to help patients better transition to pumps. Additional features and tools can be implemented as needed. 4-hour post pump initiation Address major BG issues If high BGs are not responding to boluses, change out infusion set and reservoir. If problem reoccurs, then retrain, observe patient s technique and troubleshoot the pump as necessary with Medtronic helpline assistance. If low BGs (<70 mg/dl) are occurring, adjust pump settings as required. Assess patient s comfort and confidence in basic pump functions. Infusion set changes (changed and rotated every days) Reinforce good infusion site care principles with patients. Proper site rotation pattern and avoidance of scar tissue or lipohypertrophy areas. Awareness of pain, discomfort, redness, swelling, possible infection, and irritations caused by adhesives. Assess patient s comfort and confidence with infusion set change. Address any issues associated with pain, discomfort, itch caused by tape reactions. Consider using Sure-T 0mm as it does not require a serter and has a easy 90 insertion. It works especially well for Type patients who have higher subcutaneous fat. If an infection occurs It is likely bacterial, consider oral antibiotic treatment. If it is recurrent, cleanse the site before inserting the set, apply an antibiotic ointment immediately after removing the infusion set. If an abscess occurs, drain the area and culture the fluid. If skin irritation occurs, different treatments are recommended depending on the irritant. Tape: Change type of tape. Tubing: Place tape under and over tubing (sandwich technique). Assess BGs/Adjust pump settings Adjust overnight basal first, then daytime basal, then adjust bolus. Continue to adjust pump settings as needed. Fine tuning of pump settings is accomplished faster if patient does more BG tests/day (e.g., post-prandial BG, am). If patient is experiencing nocturnal polyuria, check nocturnal BG and correct if needed. Once pump settings are appropriate, instruct the patients to do a minimum of BGs/ day. If high BG (pre-meal and/or bedtime) trend exists for weeks, ask patient to call the healthcare provider as adjustments might be needed. Sickness or infection can cause high BG. If BG is low, instruct patient to correct with a fast-acting carbohydrate. If consistent, ask patient to call the healthcare provider. Address Alerts/Alarms (Key Question: Ask patient if alarm occurred and how they addressed it) Low reservoir alert Did patient remember how to clear alarm? Does the default setting of 0 units remaining need to be adjusted? Make sure the low reservoir alert provides enough time to change infusion set and fill new reservoir. No delivery/occlusion alarm Reinforce the need to change infusion set, fill new reservoir and insert into new site to address this alarm. Reinforce having backup pump supplies available as well as syringes if needed to give insulin right away. Low battery Remind patient to: Use only AAA alkaline batteries. Have a new battery available before removing old one. Reprogram time on pump if several minutes passes without new battery insertion. Routine follow up visits Evaluate progress to determine whether patient has reached goals. Address major BG issues. Assess BG: Evaluate BG log, review CareLink Pro reports (Adherence, Meter Overview, Device Settings). Adjust settings at a time if BG log, CareLink Pro report show glycemic patterns. If patient is not at goal, consider ipro evaluation to get continuous glucose reading for further insights. Assess patient s comfort and confidence with pump therapy. Assess skin/infusion set site. Address any site issues. Assess whether adjustments to medications are needed (insulin and other medications). Based on glucose control (HbAc, BG logs), TDD (increasing), weight gain. Reinforce lifestyle habits (e.g., diet, exercise, weight management) and dietary principles (carbohydrate counting, portion control). Teach patients to identify carbohydrate and fat amount and ask them to try to limit the consumption of carbohydrate or calories to help with weight gain. If patient is not at goal, consider additional pump features and assess readiness for additional education. Use of Wizard Calculator High BG correction: for patient who is still experiencing hyperglycemia, consider using the Wizard to calculate the correction dose. Start by using Insulin Sensitivity Factor (ISF) = 700/TDD. Food: for patient who needs to better match insulin with carb-intake to reduce both high and low BGs, consider using the Wizard to calculate the suggested bolus dose based on amount of carbohydrates. Start by using Insulin to Carbohydrate Ratio (ICR) = 00/TDD. Food and BG correction: For optimum glucose control, the Wizard can calculate the suggested bolus dose based on patient s current BG, ICR, ISF and active insulin. Tracking active insulin helps prevent insulin stacking and subsequent lows. Start by using an active insulin time of 4 hours. Use of temporary basal to resolve hypoglycemia or hyperglycemia.

7 References. Edelman SV, Bode BW, Bailey TS, Kipnes MS, Brunelle R, Chen X, Frias JP. Insulin pump therapy in patients with type diabetes safely improved glycemic control using a simple insulin dosing regimen. Diabetes Technol Ther. 00 Aug;(8):67-. Labrousse-Lhermine F, Cazals L, Ruidavets JB, Hanaire H, Long-term treatment combining continuous subcutaneous insulin infusion with oral hypoglycaemic agents is effective in type diabetes. Diabetes Metab. 007;: 60. Reznik Y, Morera J, Rod A, Coffin C, Rousseau E, Lireux B, Joubert M. Efficacy of continuous subcutaneous insulin infusion in type diabetes mellitus: a survey on a cohort of 0 patients with prolonged follow-up. Diabetes Technol Ther. 00 Dec;(): Nielsen S, Kain D, Szudzik E, Dhindsa S, Garg R, Dandona P. Use of continuous subcutaneous insulin infusion pump in patients with type diabetes mellitus. Diabetes Educ :84 848, 00. Wainstein J, Metzger M, Boaz M, Minuchin O, Cohen Y, Yaffe A, Yerushalmy Y, Raz I, Harman-Boehm I. Insulin pump therapy vs. multiple daily injections in obese type diabetic patients. Diabet Med :07 046,00 6. Raskin P, Bode BW, Marks JB, Hirsch IB, Weinstein RL, McGill JB, Peterson GE, Mudaliar SR, Reinhardt RR. Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type diabetes: a randomized, parallel-group, 4-week study. Diabetes Care 6:98 60,00 7. Brahmkshatriya PP, Mehta AA, Saboo BD, Goyal RK. Characteristics and Prevalence of Latent Autoimmune Diabetes in Adults (LADA). ISRN Pharmacol. 0;0:800. Epub 0 Apr Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 0 Jun;(6):64-79 Europe Medtronic International Trading Sàrl. Route du Molliau Case postale CH- Tolochenaz Tel: +4 (0) Fax: +4 (0) United Kingdom/Ireland Medtronic UK Ltd. Building 9 Croxley Green Business Park Watford Hertfordshire WD8 8WW UK Tel: +44 (0)9 Fax: +44 (0) Wizard, ipro, CareLink and Sure-T are registered trademarks of Medtronic MiniMed, Inc. UC008 EE 04 Medtronic International Trading Sarl. All Rights Reserved. No part of this brochure may be reproduced or utilized in any form or by any means without the written permission of Medtronic International Trading Sarl. Printed in Europe.