UNCOVERING THE BENEFITS OF THE ACCU- CHEK BOLUS ADVISOR MICHAEL PORTER CDE

Transcription

1 UNCOVERING THE BENEFITS OF THE ACCU- CHEK BOLUS ADVISOR MICHAEL PORTER CDE 1

2 LEARNING OBJECTIVES By the end of this session participants should be able to understand: The benefits of bolus advisors The physiological rationale for the settings within the Accu-Chek Bolus Advisor The way the Accu-Chek Bolus Advisor corrects to mid target and handles active insulin The effects of changes in the bolus advice parameters The bolus delivery alterations available to cover various health events The key differences between the Accu-Chek Bolus Advisor and other bolus advice systems

3 Part 1: Part 2: Part 3: Part 4: Part 5: Part 6: Part 7: Part 8: Part 9: Mealtime Insulin and Bolus Advisors Meeting the new ISO standard for BGL accuracy A Wide Range of Programmable Parameters The Effects of Changing Parameters Correcting to Target Handling of Active Insulin Health Events Putting it all Together Accu-Chek Bolus Advice Simulator Workshop OUTLINE

4 Mealtime rise and post-meal hyperglycaemia Post-meal hyperglycaemia is a risk factor for: Macrovascular disease (heart attack, stroke ) Microvascular disease (retinopathy, nephropathy ) Cancer Impaired cognitive function in the elderly A meal rise of greater than 2.8mmol/L is associated with increased development of atherosclerosis 1. Slama et al. 2006, Diabetes Metab 32: Esposito et al 2008, J Clin Endo Metab 93(4):

5 Rapid-acting insulin Manufacturers product information NovoRapid Humalog Apidra Rapid-acting insulins Novo Nordisk Eli Lilly Sanofi Max effect: 1-3 hr Max effect: minutes Max effect: 55 minutes Duration of effect: 3-5 hr Duration of effect: 4 hr Duration of effect: 4 hr Maximum effect, BG starts to fall again = Offset time (1hr) Duration of effect = Acting time (4hr) References: Respective companies product information leaflets

6 Complexity of bolus calculations Everyone is different Calculations need to take into account: Current BGL Target BGL Amount of carbs to be eaten Insulin sensitivity (reduction of BGL per unit of insulin) Insulin to carb ratio Individual, situation-specific influencing factors (i.e. sport, illness, active insulin etc.)

7 Benefits of bolus advisors Reduce barriers to bolusing and improve compliance 1 Reduce number of calculation mistakes 1 Improve metabolic control 1 Less need for correction boluses or supplementary snacks respectively 2 Pre-programming allows for alternative care givers to deliver care 3 1. Glaser NS et al. J Pediatr Endocrinol Metab Gross TM et al. Diabetes Technol Ther ISPAD. Paediatric Diabetes 2007:8;88-102

8 ABACUS study 1 Participants and design Randomised 218 patients who had received carb counting training, and were on flexible daily insulin therapy Prospective, randomized, multi-center, controlled study of ~26 weeks duration Control group: Manually calculated insulin dose using on BGL and CHO intake, based on their healthcare professional s guidance Intervention group: Used the Accu-Chek Bolus Advisor, in consultation with their healthcare professional Published in Diabetes Care, Ziegler R. et al. 2013, Diabetes Care 36:

9 Achieved >0.5% HbA1c reduction ABACUS study Improved glycaemic control Patients achieving >0.5% HbA1c reduction 80% 60% 40% 20% 0% 34.4% n=32 p<0.01 Control (n=93) 56.0% n=56 In participants with poorly controlled diabetes, 63% more intervention patients achieved an HbA1c reduction of >0.5% than control participants All completers 1. Ziegler R. et al. 2013, Diabetes Care 36:

10 Achieved >0.5% HbA1c reduction ABACUS study HbA1c reduction in younger people Patients aged yrs achieving >0.5% HbA1c reduction 80% 60% 40% 20% 0% 15.0% p< % Younger participants showed particular benefit from the Accu-Chek Bolus Advisor: 3.5 times as many achieved the goal HbA1c reduction vs. control Control Accu-Chek Bolus Advisor Completers aged years* * Patient numbers not provided for this metric 1. Ziegler R. et al. 2013, Diabetes Care 36:

11 ABACUS study No increase in severe hypoglycaemia Use of the Accu-Chek Bolus Advisor was associated with: No significant increase in frequency of severe hypoglycaemia (bg <2.8 mmol/l) Significantly greater improvements in treatment satisfaction 1. Ziegler R. et al. 2013, Diabetes Care 36:

12 Bolus advisors Not all bolus advisors are equal All available bolus advisors offer similar basic characteristics: Consideration of active insulin or insulin on board Acting time setting Different bolus options Carbohydrate input Correction bolus advice Hyper/hypo warnings

13 Bolus advisors Not all bolus advisors are equal Essential differences between the Accu-Chek Bolus Advisor and other systems include: Independent certification of accuracy at the new ISO standard 1 A wide range of programmable parameters Correction to target range Handling of active insulin Consideration of health events 1. Data on file

14 Appropriate insulin dosing requires accurate BGLs Bolus calculators rely on an accurate BGL to calculate an appropriate insulin dose According to the old ISO standard, manufacturers only needed to deliver accuracy within 20% of the true BGL For a BGL of 9 mmol/l, this would mean a reading would only need to fall between 7.2 and 10.8 mmol/l This could have a significant impact on the insulin dose recommended

15 Appropriate insulin dosing requires accurate BGLs All Accu-Chek meters meet the new ISO 15197:2013 guidelines for accuracy in diabetes management, according to independent assessments 1 Independent local studies support the accuracy and precision of Accu-Chek strips, 2, 3 for example: Adapted from Roser et al, Data on file 2. Roser M et al., St Vincents Hospital, Sydney. Presented at AACB Annual Scientific Meeting, Oct Kitchener L & Freitas G, Liverpool Hospital, Sydney. Presented at AACB Annual Scientific Meeting, Sep 2008

16 A wide range of programmable parameters The Accu-Chek Bolus Advisor has additional programmable parameters to better simulate rapidacting insulin action Meal rise Offset time Snack size This enables patients and HCPs to adjust the bolus advice settings to their individual needs and, most importantly, better manage post-meal BGLs

17 Blood glucose level (mmol/l) Meal rise (2.8 mmol/l) Insulin acting time (hours) The Accu-Chek Bolus Advisor Overview Offset time Length of time after a bolus until a reduction in BG begins Meal rise Expected rise in BGLs in response to a meal 8.8 Offset time (1 hr) Acting time Total length of time the insulin is expected to be lowering BG Target range Normal time course of insulin action Acting time (4 hr) Accu-Chek Bolus Algorithm Allowable BG range while insulin is acting Correction Bolus Calculation Out of range BGLs during the acting time trigger corrections

18 Blood glucose level (mmol/l) Meal rise (2.8 mmol/l) The Accu-Chek Bolus Advisor Step by Step Offset time Length of time after a bolus until a reduction in BG begins Meal rise Expected rise in BGLs in response to a meal 8.8 Offset time (1 hr) Acting time Total length of time the insulin is expected to be lowering BG Target range Normal time course of insulin action Acting time (4 hr) Accu-Chek Bolus Algorithm Allowable BG range while insulin is acting Correction Bolus Calculation Out of range BGLs during the acting time trigger corrections Insulin acting time (hours)

19 Blood glucose level (mmol/l) Insulin acting time (hours) The Accu-Chek snack size function Meals vs snacks Meal Snack Physiologically, there is a minimal rise in the BGL expected after a snack compared to a meal

20 The Accu-Chek snack size function Definition Every carb intake entered into Bolus Advisor will trigger calculation However, the activation of the Meal Rise feature for the a depends on the Snack Size parameter (set between 0 24g c The Snack Size setting defines a certain threshold above w Meal Rise bg pattern is triggered When a user enters carbs that are within the Snack Size se a bolus is calculated but the Meal Rise is not triggered For example: If Snack Size setting = 15g One biscuit is eaten, in this case = 12g

21 The Accu-Chek Bolus Advisor Allows for adjustments with snacks The snack size function: Prompts a meal-centric dose to cover small amounts o For carbs within the Snack Size setting, a meal-rise is no allowing high BGLs between meals to be addressed With a meal rise Without a meal rise od glucose level (mmol/l) Pre-meal level Meal Snack Insulin acting time (hours) These high post-meal BGLs will no receive a correction recommend

22 Without snack size functionality bg level FREQUENT MEALS COULD CAUSE A CONSTANT MEAL RISE ELEVATED BGLS WOULD BE CONSTANTLY ALLOWED NO RECOMMENDATION SUGGESTED POORER CONTROL AND HIGHER HBA1C

23 Blood glucose level (mmol/l) The Accu-Chek Bolus Advisor Allows for adjustments with snacks The snack size function: Prompts a meal-centric dose to cover small amounts For carbs within the Snack Size setting, a meal-rise is n allowing high BGLs between meals to be addressed Meal Snack Meal Snack Meal Insulin acting time (hours)

24 Blood glucose level (mmol/l) The Accu-Chek Bolus Advisor Allows for adjustments with snacks The snack size function: Prompts a meal-centric dose to cover small amounts For carbs within the Snack Size setting, a meal-rise is n allowing high BGLs between meals to be addressed Without a snack size funct this high BGL would have b left unaddressed due to th larger allowable range Meal Snack Meal Snack Meal Insulin acting time (hours)

25 The Accu-Chek Bolus Advisor Allows for adjustments with snacks So if Mary is only eating a small amount Snack size allows the user to designate an amount of carbs above which a meal rise will be triggered* This is extremely useful for frequent eaters, such as children More than this meal rise * A meal bolus will still be recommended to cover the carbs Less than this no meal rise

26 Blood glucose level (mmol/l) Meal rise (2.8 mmol/l) The Accu-Chek Bolus Advisor Offset time Length of time after a bolus until a reduction in BG begins Meal rise Expected rise in BGLs in response to a meal Target range Offset time (1 hr) Normal time course of insulin action Acting time (4 hr) Snack eaten No meal rise 4 Acting time Total length of time the insulin is expected to be lowering BG Accu-Chek Bolus Algorithm Allowable BG range while insulin is acting Correction Bolus Calculation Out of range BGLs during the acting time trigger corrections Snack Size Eating more than this amount of carbs will trigger a meal rise Insulin acting time (hours)

27 The Accu-Chek Bolus Advisor The Accu-Chek Bolus Advisor allows a wide range of parameter settings, increasing your ability to personalise healthcare: Acting time: 1:30 to 8:00 hours Offset time: 0:45 to 7:45 hours Meal BG rise: 2.8 to 11.1 mmol/l Snack size: 0 to 24 g

28 Blood glucose level (mmol/l) The Accu-Chek Bolus Advisor Adjusting acting time With shorter acting time, bolus recommendations may be higher. If acting time is too short it may increase the risk of excess insulin and of hypos With longer acting times, bolus recommendations are more moderate Insulin acting time (hours)

29 Blood glucose level (mmol/l) The Accu-Chek Bolus Advisor Adjusting offset time With shorter offset time*, bolus recommendations may be higher With longer offset times, bolus recommendations are more moderate Insulin acting time (hours) *For added safety, minimum offset time is 45 minutes

30 Blood glucose level (mmol/l) The Accu-Chek Bolus Advisor Adjusting meal rise With lower meal rise, bolus recommendations may be higher With higher meal rise, bolus recommendations are more moderate Insulin acting time (hours)

31 The Accu-Chek Bolus Advisor Adjusting snack size Allows users to determine their level of control in managing BGLs For tighter control the snack size may be set at the highest level (24 grams) Some users prefer to avoid potential insulin stacking over-correction caused by the first bolus after the snack (and potential hypoglycaemia) - so may set the snack size to 0 grams

32 The Accu-Chek Bolus Advisor Overview of parameter adjustments Expanding the allowable range (trapezoid) up or right allows higher BGLs, and moderates the recommendations Shrinking the allowable range (trapezoid) down or left leads to higher insulin dose recommendations Looser control Tighter control

33 Blood glucose targets Upper and lower targets can be specified BG targets for the Accu-Chek Bolus Advisor are calculated as the mid-point between the upper and lower limits If an individual s target range is 4-8 mmol/l, the mid-point will be 6 mmol/l Upper Limit Lower Limit Middle of target range

34 Why treat to the middle of the target range? Tighter control in response to high BGLs Return to a more normal BGL in response to low BGLs

35 Accu-Chek bolus advice Correction to middle of target range No mealtime insulin dose required Mealtime insulin dose required No correction Middle of target range

36 Corrections when not taking mealtime insulin Accu-Chek Medtronic Animas Insulinx 8 No correction No correction No correction 4 As there is no mealtime insulin dose being taken, the Accu Bolus Advisor does not recommend an extra injection/ e unless BGLs are above the target range

37 Corrections when taking meal insulin Accu-Chek Medtronic Animas Insulinx 8 No correction No correction 4 The Accu-Chek Bolus Advisor offers the tightest correc recommendations, to optimise high and low BGLs

38 Insulin (units) Correcting to target Better glycaemic control with Accu- Chek Accu-Chek Medtronic Animas Correction dose Meal dose Mealtime bolus dose recommendations with pre-prandial BGL = 9.7 mmol/l: All bolus advisors recommended 5.3 units to cover carbs ( ) Accu-Chek and Animas systems recommended a correction dose of 1.3 units; the Medtronic system only suggested 0.6 units ( ) 1. McDaniel, A, et al. 2nd Intl Conference on Advanced Technologies & Treatments for Diabetes, A237, 2009

39 HANDLING OF ACTIVE INSULIN Two distinct targets for BG control For people with Type 1 Diabetes, treatment needs to: 1. Provide insulin to store mealtime glucose: Mealtime or meal-centric insulin Only maintains the pre-meal BGL 2. Provide insulin to correct high BGLs: Correction or glucose-centric insulin Will not address mealtime carbs Reduces BGL These are addressing different issues with the person s diabetes and shouldn t be merged together

40 Putting it together Mary is high and hungry Mary s carb ratio is 1:15 and her ISF is 1: 3 Mary is about to eat 60g of carbs, and her BGL is 12 mmol/l. How much insulin should she have with her meal? To cover the carbs? To bring BGL down to 6? Mary s total dose? 4 Meal-centric 2 Glucose-centric (Correction/Active Insul Total = 6 units of insulin

41 Active insulin and other bolus advisors Most bolus calculators will recommend meal and correction doses at mealtime However, only the Accu-Chek Bolus Advisor keeps meal and glucose-centric insulin separate in its memory for later bolus calculations Accu-Chek Other bolus advisors 4 Meal-centric: To address carb intake 6 Active insulin or insulin on board 2 Glucose-centric or active insulin: To address high BGLs

42 * Insulinx allows single target or target range to be selected Active insulin and other bolus advisors The Accu-Chek system recognises that there is a smaller amount of insulin available to lower BGLs Accu-Chek 2 Glucose-centric or active insulin Medtronic 6 Animas Insulinx* Active insulin, or insulin on board 6 Active insulin, or insulin on bo Higher probability of correction! Lower probability of correction! Lower probability of correction! The Accu-Chek Bolus Advisor is more likely to recommen correction doses than other bolus advisors

43 Insulin (units) Handling of active insulin Tighter post-meal control with Accu-Chek Correction recommended Accu-Chek Medtronic Animas * Animas 2020 and Medtronic Paradigm bolus calculators 2-hour postprandial bolus recommendations, for BGL of 13.7 mmol/l: Other systems* overestimated the active insulin ( ) The Accu-Chek Bolus Advisor was the only system to recommend correction insulin to address postprandial hyperglycaemia 2 hours after the meal ( ) 1. McDaniel, A, et al., 2009, 2nd Intl Conference on Advanced Technologies & Treatments for Diabetes, A237

44 Meals Handling of active insulin Tighter post-meal control with Accu-Chek 1 Number of correction boluses recommended at 2 hr n= n= Accu-Chek Medtronic 72 meals 69 meals The Accu-Chek Bolus Advisor recommended more correction boluses at 2 hrs post-meal than the Medtronic Paradigm bolus wizard, with more BGLs returning to target at 6 hours This was achieved without an increase in hypoglycaemia 1. Zisser H, et al. Diabetes Technol Ther. 2010; 12(12):

45 Health events No two days are the same A number of different circumstances can affect insulin needs on a day-to-day basis, such as: Sickness Exercise Stress Being pre-menstrual In the past, people had to guess how to account for these variations when estimating insulin

46 Consideration of health events The Accu-Chek Bolus Advisor is the only system that incorporates Health Events : Exercise 2 programmable event fields to allow for different exercise regimens Stress Illness Premenstrual Helps adjust bolus advice to individual needs Helps people understand and remember factors that they should consider with their bolus delivery!

47 The Accu-Chek Bolus Advisor Health events settings to support bolus advice Exercise increases insulin sensitivity Health Events allow you to account for lower insulin needs around exercise Other life factors may increase insulin needs (Stress, Illness, Premenstrual status)

48 Blood glucose level (mmol/l) Meal rise (2.8 mmol/l) Insulin acting time (hours) IN SUMMARY The Accu-Chek Bolus Advisor Offset time Length of time after a bolus until a reduction in BG begins Meal rise Expected rise in BGLs in response to a meal Target range Offset time (1 hr) Normal time course of insulin action Acting time (4 hr) Snack eaten No meal rise 4 Acting time Total length of time the insulin is expected to be lowering BG Accu-Chek Bolus Algorithm Allowable BG range while insulin is acting Correction Bolus Calculation Out of range BGLs during the acting time trigger corrections Snack Size Eating more than this amount of carbs will trigger a meal rise

49 1. Check bgl Simple, discreet delivery of recommended bolus doses 3. Deliver Insulin Blood glucose Active insulin Enter carbs Health 2. Enter Carbs and any adjustments Correction Meal insulin insulin Health Bolus adjustment

50 1. Data on file The Accu-Chek Bolus Advisor Summary of advantages 1. Independent certification of accuracy - at the new ISO standard 1 2. Corrects to midpoint of target range - provides bolus recommendations for better control 3. Only correction insulin is treated as active - ability to recommend higher corrections when required 4. Offers a wider range of programmable parameters - meal rise, offset time and snack size to better fit individual needs 5. Offers additional parameter of health events - offers quick customisation to changing daily circumstances

51 The Accu-Chek Bolus Advisor Evidence-based insulin management The Accu-Chek Bolus Advisor is used in both the Accu- Chek Combo insulin pump system and the Accu-Chek Aviva Expert meter Peer-reviewed research confirms the value of the Accu- Chek Bolus Advisor: 1. Ziegler R. et al. 2013, Diabetes Care 36: 3613

52 Questions?

53 Presentation endorsed by ADEA for 2 CPD Points.