Using the Accu-Chek Aviva Expert Bolus Advisor Diabetes Education Network May, 2012
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Using the Accu-Chek Aviva Expert Bolus Advisor
Diabetes Education NetworkMay, 2012
Dr K Barnard CPsychol AFBPsS
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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
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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
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What Does Motivation Look Like?
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What Does Motivation Look Like?
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Does You Feel Like This Sometimes?
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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
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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
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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
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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
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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
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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
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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?
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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
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Bolus Calculations
Based on 3 meals a day, no snacks:– 21 calculations a week– 84 calculations a month– 1095 calculations a year
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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
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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.
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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
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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.
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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
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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
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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.”
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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.”
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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
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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
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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
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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)
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Method
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Results
Baseline 16 weeks Change Change Adjusted for Baseline HbA1c
Control 9,1 ± 0,7% 8,9 ± 1,1% -0,1% (-1,0 – 0,7%)
0,0% [Reference]
CarbCount
9,2 ± 0,6% 8,4 ± 0,9% -0,8% (-1,3 – -0,3%)
-0,6% (-1,2 – 0,1%)
CarbCountABC
8,8 ± 0,7% 8,1 ± 0,4% -0,7% (-1,0 – -0,4%)
-0,8% (-1,4 – -0,1%)
p = 0.056
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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
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UK/Germany Next StepsDesign: • 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
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RCT Primary Outcome• Determine whether use of a BA improves
glycemic control in people treated with multiple daily insulin injections (MDI)
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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
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ResultsThe 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
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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)
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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
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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