patient education: lessons learnt from abacus dr katharine barnard cpsychol afbpss may 2013
TRANSCRIPT
Patient Education: lessons learnt from ABACUS
Dr Katharine Barnard CPsychol AFBPsSMay 2013
Imagine• You have a puzzle that you cannot solve
• Every day you think carefully about the puzzle but there is no solution
• Some days the solution to the puzzle is tantalisingly close
• Other days the solution is elusive
• You ask others if they have the solution but they do not
Imagine• If you had to live life like this every single day ...
• For the rest of your life …
• And that your life depended on …
your being able to solve that puzzle
Sword of damocles• Go blind
• Foot amputation
• Kidney failure
• Cardiovascular disease
Burden of Diabetes
People feel:
• Isolated
• Lonely
• Ugly
• Afraid
• Burned-out
Bolus Calculations• You have insulin
treated diabetes
• You eat carbohydrates
• You need an insulin bolus every time you eat CHO’s
• You have an I:CHO ratio, an ISF and a target range
Example One
• Current blood glucose = 5.5
• I:CHO ratio = 1 unit of insulin for 10g CHO
• ISF = 1 unit of insulin to reduce by 2
• Target range = 4-7
• 100g CHO meal
Example One• Current blood glucose = 5.5
• I:CHO ratio = 1 unit of insulin for 10g CHO
• ISF = 1 unit of insulin to reduce by 2
• Target range = 4-7
• 100g CHO meal
• Units of insulin required = 10 units
Example Two• Current blood glucose = 5.5
• Add exercise after meal = 60 minutes
• 60 minutes’ exercise will drop bg by 6
• I:CHO ratio = 1 unit of insulin for 10g CHO
• ISF = 1 unit of insulin to reduce by 2
• Target range = 4-7
• 100g CHO meal
Example Two• Current blood glucose = 5.5
• Add exercise after meal = 60 minutes
• 60 minutes’ exercise will drop bg by 6
• I:CHO ratio = 1 unit of insulin for 10g CHO
• ISF = 1 unit of insulin to reduce by 2
• Target range = 4-7
• 100g CHO meal
• Units of insulin required = 7 units
Let’s Be More Realistic• What if:
• Current bg level is 9.3
• I:CHO ratio = 1 unit of insulin for 8g CHO
• Meal contains 67g CHO
• Doing 45 minutes of exercise
• ISF = 1 unit to reduce by 2
• How many units now?
Let’s Be More Realistic• What if:
• Current bg level is 9.3
• I:CHO ratio = 1 unit of insulin for 8g CHO
• Meal contains 67g CHO
• Doing 45 minutes of exercise
• ISF = 1 unit to reduce by 2
• Units of insulin required = 7.5 units
Maths Check
“I tried to check the maths.
I have grade A "A level" maths (passed with 100%) and was originally accepted to Cambridge to study physics and despite this, when I checked your numbers, I felt over-whelmed and went to pieces and honestly can't do the sums”.
13
Margin of Error
• ‘Best guess’ approach
• ‘Little bit wrong’ every bolus dose
• What would be the cumulative effect of all of those errors?
Hidden Difficulties• 45% of UK adults have only primary school maths
(aged >10 yrs)
• Approximately 20% of adults lack basic numeracy skills
• Diabetes is non-discriminatory
• GCSE maths (aged 16 yrs) is required to calculate a bolus dose accurately
• CHO counting alone is insufficient
Results of the Automated Bolus Advisor Control and Usability Study (ABACUS)
Ralph Ziegler, David A. Cavan, Iain Cranston, Katharine Barnard, Jacqueline Ryder, Claudia Vogel, Christopher G. Parkin, Walter Koehler, Iris Vesper, Bettina Petersen, Matthias Axel Schweitzer, Robin S. Wagner
Does Use of an Insulin Bolus Advisor Improve Glycemic Control in Patients Not Achieving
Optimal Control Using MDI?
Manual Bolus Calculation Creates Obstacles for Patients
• Discourages adherence to therapy:
– Manual bolus calculation is complex, difficult, time-consuming, and requires mathematical skills and competence in carbohydrate counting
– Patients may skip a bolus or rely on empirical estimates, which can lead to severe clinical consequences1,2
• Compromises patient safety:
– Manual calculation does not account for the effect of active insulin remaining from previous bolus, which can lead to inappropriate “stacking” of boluses, resulting in hypoglycemia3
1. Pickup J et all. Diabetes Care 2002;25:593-598. 2. Bode BW et al, Diabetes Metab Res Rev 2002;18 (Suppl 1):S14-S20.3. DeWitt DE and Hirsch IB. JAMA 2003;289(17):2254-2264.
Study Overview• Primary Objective:
– Determine if use of an insulin bolus advisor improves glycemic control
• Study Goal: – Decrease HbA1c by >0.5% in each participant
• Secondary Objectives:
– Improvements in glycemic variability
– Bolus advisor use and adherence to MDI rules
– Changes in psychosocial factors
– Frequency and severity of hypoglycemia
Accu-Chek® Aviva Expert
The Accu-Chek® Aviva Expert blood glucose meter:
• Contains an integrated bolus advisor
• Presents meal and correction bolus recommendations based upon current bG value, planned CHO intake and patient-specific therapy parameters stored in the device
• Stores blood glucose and meal information in an electronic diary
Study Protocol• All Participants
– 6-month randomised trial using Accu-Chek Aviva Expert meter (EXP) vs Accu-Check Aviva Nano (CNL)
– Baseline CHO Counting/MDI competency assessments and remedial training based on identified deficits (knowledge/DAFNE plates)
– Psychosocial Assessments at baseline and study end
– Structured SMBG (3-Day, 7-Point Profiles) at beginning, midpoint and end of study
– SMBG data downloaded and reviewed at every visit to adjust treatment parameters
– Continuous Glucose Monitoring (CGM) in “blinded” mode (approximately 50% of subjects) at beginning, midpoint and end of study
Study Timeline
Visit 2Train and
Randomize
241240
Visit 1Screening Start CGM
Visit 3Start
BA
Visit 4Tx Check (phone)
Visit 5Therapy Check
Visit 7Therapy Check
Visit 8Start CGM
Visit 6Start CGM
Visit 9Study End
Visit 10Call
Total intervention is 24 weeks
Type 1 and Type 2 >7.5 HbA1c MDI Therapy
Training in MDI/CHO Counting within past 2 years
Interventions• Control Participants (CNL)
– Monitored blood glucose and manually calculated bolus insulin dosages based on test results
– Insulin dosage parameters were checked/adjusted at all visits
• Intervention Participants (EXP)
– Monitored blood glucose and used Bolus Advisor to calculate bolus insulin dosages
– Insulin dosage parameters in Bolus Advisor were checked/adjusted and updated in device at all visits
Screened
n=229
Interventionn=105
Randomized
n=218
Controln=113
Completersn=100
Completersn=93
Drop-outsn=5
Drop-outsn=20
Drop-outsn=11
8 eligibility not met
3 withdrew consent
9 withdrew consent
4 noncompliant
3 withdrew consent
and noncompliant
1 surgery/illness
3 lost to follow up/other
2 noncompliance
1 withdrew consent
and noncompliant
1 surgery/illness
1 pregnancy
Participant Disposition
%Completers Achieving >0.5% HbA1c ReductionAll Completers
• Bolus advisor use was associated with a 63% greater chance for achieving HbA1c reduction of >0.5%
• Average HbA1c reduction of -1.2% in both groups
Glycemic Variability (CGM)Mean Amplitude of Glucose Excursion (MAGE)3-Day Profile Days: All CGM Completers
Changes in MAGE correlated with SD of glucose values (r = 0.87) and were independent of education level, diabetes duration, duration of MDI and gender
Frequency of bG <50 mg/dL / 2.8 mmol/L All Completers
Use of the Bolus Advisor not associated with increased frequency of severe hypoglycemia
Val
ues
<50
mg/
dL /
2.8
mm
ol/L
(%
) p=0.5880 p=0.1251 p=0.0764 p=0.0519 p=0.4698 p=0.1639 p=0.8876 p=0.87038
7
6
5
4
3
2
1
0
-1 V1-2 V2-3 V3-4 V4-5 V5-6 V6-7 V7-8 V8-9
Control Intervention
86 92 50 75 86 90 85 91 85 91 85 91 86 91 86 92N =
CHO and MDI Knowledge Assessments and Checklists
CHO and MDI Knowledge Association with Baseline HbA1c
28
High competency (Perfect Score) in CHO/MDI knowledge was associated with lower HbA1c values
Carbohydrate Counting AssessmentDAFNE Plates
CHO Counting CompetencyCompleters
Significant improvement in MMAE (- 2.8 (8.2), p<0.01) and a trend towards improvement in MME in the EXP group but no change in CNL
Baseline V9
Baseline V9
Control (N=113)
Intervention (N=105)
MME (Accuracy) gMMAE (Variability) g
1.6 (10.1) / 14.6 (9.7) 1.0 (9.7) / 13.3 (9.9)
1.0 (10.1) / 15.2 (9.0) 0.3 (7.1) / 12.4 (7.3)
Use of MDI Rule SetsControl
Patient-recorded bolus calculations from 3-day profiles were checked to determine if their stated I:CHO and ISF rules were used
in a mathematically correct manner for each bolus calculation
Bolus Advisor Utilization Intervention
All(n=105)
Advice used during study (SD), % 73.5 (21.9)
Advices sought per day (SD), n 2.8 (1.2)
Advices accepted per day (SD), n 2.5 (1.1)
Advices modified per day (SD), n 0.3 (0.5)
Doses adjusted up per day (SD), n 0.1 (0.2)
Doses adjusted down per day (SD), n 0.2 (0.4)
• High percentage of use, overall; however daily frequency of advice sought decreased significantly (-0.2 per day, p<0.01) by study end
• Patients were twice as likely to reduce their insulin vs. increase dose
• Significantly more EXP than CNL patients had changes in their insulin sensitivity factor (ISF) settings at Week 4 (24.5% vs. 10.8%, p<0.05) and Week 12 (29.3% vs. 8,6%, p<0.01).
• The number of different ISF settings used during the day were increased significantly in EXP vs. CNL patients at all visits (p<0.05).
• The number of ISF settings significantly increased longitudinally from baseline to study end in EXP but not CNL patients (p<0.05).
• The number of changes in I:CHO settings showed a similar not statistically significant trend, with more EXP than CNL patients receiving I:CHO changes at Week 4 (35.7% vs. 25.8%, p=NS) and Week 12 (44.4% vs. 33.0%, p=NS).
• The number of I:CHO settings significantly increased longitudinally in EXP but not CNL patients from the start to the end of the study (p<0.05).
Bolus Advisor Utilization Changes of Parameters
Treatment Satisfaction Improvement in DTSQ score from Baseline: Completers
• EXP patients reported significantly greater improvement in treatment satisfaction from baseline than CNL patients
• Baseline for CNL and EXP: 27.9 (6.1) vs. 28.0 (6.1); p=NS
• More EXP participants achieved >0.5% HbA1c reduction than CNL
• Use of Bolus Advisor was a/w reduced glycemic variability but not higher frequency of severe hypos
• Overall, participants sought/accepted bolus advice around 75% of the time
• Participants using manual bolus calculation followed their “Rule Sets” only 26% to 47% of the time
• Use of bolus advisor is a/w improved CHO competency
• Participants who used the bolus advisor had more frequent changes in and more different I:CHO and ISF parameters
Summary
Key Messages• CHO-counting and MDI skills at baseline are
variable (despite education – so should such education include an assessment of skills learnt?)
• There was an improvement in CHO estimation in the Expert group and an overall benefit in the Expert group
• Bolus calculators can facilitate greater diabetes control
• People use devices differently - use should ‘best fit’ with individual needs and personal circumstances
Key Questions:• Do people with diabetes really understand and
value the importance of accurate CHO counting?
• How easy is it to fit accurate CHO counting into daily living realistically?
• Do we support self-efficacy in CHO counting in the personal context of diabetes?
• Is it possible to put education into context of everyday living against competing priorities?
