1. Using the Accu-Chek Aviva Expert Bolus Advisor Diabetes Education Network May, 2012 Dr K Barnard CPsychol AFBPsS

2. Overview Diabetes and personal motivation Hidden challenges facing people with diabetes Accu-Chek Aviva Expert Bolus Advisor How can we use the bolus advisor to support patient self-management

3. The Here and Now – Diabetes is Tough Sustained daily effort to maintain ‘good’ diabetes control Lots of new rules ….. BUT no cure Abundant and sometimes competing medical advice from HCPs and family/friends No obvious immediate benefit No guarantees

4. What Does Motivation Look Like?

6. Does You Feel Like This Sometimes?

7. Ignorance? Assumption: simply increasing patients' knowledge of treatment would be an effective means of reducing non-compliance (Ley 1988) We know that this is not true. One of the biggest barriers to optimal self management is the ability to calculate bolus doses

8. Hidden Difficulties Complex mathematical calculations required to work out bolus insulin requirements 45% of UK adults have only primary school maths ability i.e. aged 7-10 years GCSE maths or above is required for effective bolus calculations Approx 80% of people struggle with the maths a/w bolus dosing

9. Barriers to Intensification Many patients do not intensify their insulin regimens because of fear of hypoglycemia. One severe hypo can be a strong deterrent from having another one A significant percentage of patients with diabetes remain well above their glycemic goals Intensification of therapy can improve glycaemic control and reduce risk of complications

10. Sub-optimal Self-Management Despite the proven benefits of effective diabetes management, many people with diabetes are reluctant or unable to follow and/or adjust their insulin regimens as needed Many people with T1DM perform self- monitoring of blood glucose (SMBG) at suboptimal levels

11. Support for Self Management Structured education e.g. DESMOND, EXPERT, DAFNE, BERTIE Individualised treatment plans in collaboration with patient Carbohydrate counting tools e.g. carbs and cals Bolus advisor

12. Bolus Calculation Requirements Calculation of an insulin dose is a complex process requiring knowledge of: – Pre-prandial glucose level – grams of carbohydrate – insulin sensitivity – insulin-to-CHO ratio – active insulin on board

13. Why So Hard? Maths: 1 unit of insulin for 10g carbs. Eating 100g carbs. BG 4.8; no exercise planned. BUT: how often in reality is it that straightforward?

14. More Typically … 1 unit of insulin for 13g carbs. Eating 68g carbs. BG 9.4; (ISF 1.5 units to lower bg by 3) no exercise planned. OR: 1 unit of insulin for 8g carbs. Eating 115g carbs. BG 12.3; (ISF 1.2 units to lower bg by 2); stressful meeting planned

15. Bolus Calculations Based on 3 meals a day, no snacks: – 21 calculations a week – 84 calculations a month – 1095 calculations a year

16. Bolus Calculations So if you throw in a biscuit with your morning coffee and a bit of supper: Based on 3 meals a day, plus 2 snacks: – 35 calculations a week – 150 calculations a month – 1,825 calculations a year

17. Accu-Chek Avia EXPERT Meter An insulin bolus advisor (BA) can help reduce the burden of diabetes self management – The BA recommends the appropriate insulin dose according to the carbohydrate contf content of meals, current blood glucose level and patient target range – Difficult calculations can be avoided; enabling greater accuracy in insulin boluses; and reduced risk of long term complications BA use is safe and effective in managing postprandial glucose excursions Gross et al, 2003; Zisser et al, 2010.

18. Existing Use of Bolus Advisors bolus advisors have been very effective in insulin pump therapy to help people accurately calculate their insulin doses Once a person’s individual parameters have been set into the device, in association with clinical team, the only requirement is to tell the device how many carbs are in a meal and what the current b.g. level is

19. Pilot Data Survey of 1,412 T1DM patients treated with MDI at 270 hospitals in the UK and Republic of Ireland Aim: to assess attitudes and behaviors regarding insulin therapy after use of a bolus advisor Participants: 588 respondents; age 0-70 years, diabetes duration of 0 - >15 years. Respondents had 4-12 weeks prior experience using the bolus advisor.

20. Pilot Data Results: – 52.0% of respondents indicated that fear of hypoglycemia was reduced (39.0%) or significantly reduced (13.0%) – 78.8% indicated that confidence in the insulin dose calculation improved (50.8%) or significantly improved (28.0%) – 89.3% indicated that the bolus advisor made bolus calculation easy or very easy compared with manual calculation Barnard et al. J Diab Sci Tech, 2012

21. What Does That Mean? No more difficult and complicated mathematical equations to work out every time you eat Less stress a/w meal times Parents report reduced anxiety and increased confidence in their children’s ability to self- manage at school

22. What Participants Said “It has changed my life, HbA1c is 8 from 12.” “It has made me a healthier person and made living with diabetes a lot easier” “Makes me feel more secure in my control.” “HbA1c is down from 10.9 to 8.3 mmol/l and is a great tool for my driving ability and convenience.”

23. What Participants Said “I have much more confidence now and don’t fear hypos because of it.” “I feel more confident about the insulin dose I have to take when eating.” “It has given us the confidence to move to MDI and made the transition an awful lot easier.”

24. Conclusions Using the bolus advisor was easier than manual bolus calculation Reduced fear of hypoglycemia Increased confidence in bolus calculation Improved ability to control bG levels and achieve glycemic goals, Sense of increased flexibility in lifestyle, and improvement in overall well being

25. Hvidovre Hospital Data The BolusCal Study Use of Flexible Intensive Insulin Therapy and an Automated Bolus Calculator in MDI Treated Type 1 Diabetes A study of the effects of carbohydrate counting and and automated bolus calculator in patients with poorly controlled type 1 diabetes treated with multiple daily injections PI: Signe Schmidt, Dept of Endocrinology

26. Hypotheses Non-optimally treated, carbohydrate counting- naïve patients with type 1 diabetes can achieve better metabolic control, treatment satisfaction and quality of life by counting carbohydrates The benefits can be further improved by concurrent use of an automated bolus calculator HbA1c primary outcome Secondary psychosocial outcomes and change in distribution of bg values

27. Design A 16-week randomized controlled study Inclusion criteria : Age 18-65 years; Diabetes duration ≥ 12 months; HbA1c 8-10.5%; MDI therapy (rapid-acting analog for meals; long-acting analog as basal) Exclusion: Current or former practice of carbohydrate counting; Gastroparesis; Pregnancy or nursing 3 parallel study arms: - Control (MDI) - CarbCount (MDI and carb count) - CarbCountABC (MDI, carb count, bolus advisor)

28. Method

29. Results Baseline16 weeksChangeChange Adjusted for Baseline HbA1c Control9,1 ± 0,7%8,9 ± 1,1%-0,1% (-1,0 – 0,7%) 0,0% [Reference] Carb Count 9,2 ± 0,6%8,4 ± 0,9%-0,8% (-1,3 – -0,3%) -0,6% (-1,2 – 0,1%) Carb Count ABC 8,8 ± 0,7%8,1 ± 0,4%-0,7% (-1,0 – -0,4%) -0,8% (-1,4 – -0,1%) p = 0.056

30. Conclusions Non-optimally treated, carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control, treatment satisfaction and quality of life by counting carbohydrates The benefits can be further improved by concurrent use of an automated bolus calculator

31. UK/Germany Next Steps Design: Prospective, randomized, multi-centre study (17 German centres; 16 UK centres) Duration: 26 weeks from November 2011 Sample Size: 285 – assuming a drop-out rate of 20% Sample size of 228 (114 per study group) results in ≈80% power to detect a mean difference of 0.5%, with SD of 0.9% presuming a one-sided 5% significance level, by taking two age strata (18-30 years & >30 years) into account

32. RCT Primary Outcome Determine whether use of a BA improves glycemic control in people treated with multiple daily insulin injections (MDI)

33. Secondary Outcomes Change in time spent within blood glucose (bG) target range Frequency and severity of hypoglycaemia Change in glycaemic variability parameters Change in magnitude of postprandial glucose excursions Frequency of bolus advisor use Frequency of participant adjustments to proposed bolus amounts Self Monitoring of Blood Glucose test frequency Change in participants’ therapy adherence and use of rule sets

34. Results The BA has the potential to: Help patients on MDI therapy safely and more effectively manage their diabetes, thus reducing both acute and long-term complications Reduce the burden of diabetes self- management, contributing to improved diabetes control and quality of life

35. So What Difference Will It Make? Using the bolus advisor removes a major barrier to effective self-management Helping patients to overcome a major hurdle increases self-efficacy Increased self-efficacy is associated with improved diabetes control (both biological and psychosocial)

36. Goals – Who Knows Best? We may (and often do) know the best medical advice to achieve optimal diabetes control BUT Only our patients know whether they are willing or able to achieve it

37. Diabetes Well controlled diabetes is the leading cause of ……. NOTHING Optimising biomedical control alongside psychosocial management is crucial Removing a major barrier to optimal diabetes control is a massive step forward

38. Thank you Any questions? For further information, please contact: K.barnard@soton.ac.uk