Use of the Estimated Average Glucose (eAG) in Patient Care, Part 2

Use of the Estimated Average Glucose
(eAG) in Patient Care
Part 2 of 2
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ADAG Study: Glucose Monitoring
• CGM – mean of ~ 2,400 measurements per
participant
• LifeScan meter ~ mean of 300 measurements per
participant
– Mean of ~ 25 measurements per week
– Goal was a minimum of 21 tests per week
• Total ~ 2,700 measurements/participant during 12
weeks
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ADAG Study: Analyses
• CGM results corrected upward by 5% to be
consistent with BG
• Each glucose measure weighted in proportion to
the inverse of total number of measurements on
that day (each day had equal weight)
• Arithmetic mean glucose calculated for each
participant
• Linear regression model used to estimate
relationship between average glucose and the
3-month HbA1c
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ADAG Study: Study Success
18
16
90% of
cohort values
fall in this range
14
12
10
8
6
4
2
0
HbA1c (%)
90% of values fell within +/- 15%
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AG (mg/dl)
ADAG Study: Correlation of AG
With HbA1c
AG (mg/dl) = 28.7 x HbA1c – 46.7
R2 = 0.84
P < 0.0001
HbA1c (%)
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ADAG Study: Correlation of AG
with HbA1c: CGM data vs. Meter
18
CGM calc. AG = 1.649x - 2.645
Calc. AG (mmol/L)
16
2
R = 0.768
14
12
No difference in
relationship (P=0.18)
whether LifeScan or
CGMS data used
10
8
6
4
2
0
3
4
5
6
7
8
9
10
11
12
HbA1c (%)
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13
ADAG Study: Other Factors Examined
• Does the HbA1c-Average Glucose relationship
differ by:
- Type 1 or type 2 diabetes NO
- Diabetes or no diabetes NO
- Amount of glucose variability NO
- Gender NO
- Age NO
- Ethnicity/Race NO
(but trend toward higher HbA1c per AG in African
and African-American participants vs. whites, P=0.07)
- Smoking NO
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ADAG Study Excluded Known Sources
of “Inaccuracy” of HbA1c
•
•
•
•
•
Hemoglobinopathy
Anemia
Pregnancy
Hepatic or renal disease
Etc.
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ADAG Study Conclusion:
HbA1c Correlates Highly With AG
450
400
AG (mg/dl)
350
AG (mg/dl) = 28.7 x HbA1c – 46.7
300
250
200
150
100
50
3
4
5
6
7
8
9
10
11
12
13
Measured HbA1c (%)
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Implications
• Tight correlation between HbA1c and AG
allows us to translate HbA1c into an
estimated Average Glucose (eAG)
• eAG will apply to the majority of patients
with diabetes
– Barring “traditional” conditions interfering
with the assay or the relationship between
glycemia and HbA1c
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ADAG Study: “Translation” of
HbA1c into eAG
HbA1c (%)
5
6
7
8
9
10
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eAG
(mg/dl)
(mmol/l)_
97
5.4
126
7.0
154
8.6
183
10.2
212
11.8
240
13.4
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Note that the numbers are different
HbA1c (%)
6
7
8
9
10
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ADAG
DCCT
(mg/dl)___(mg/dl)______
126
135
154
170
183
205
212
240
240
275
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Consensus Statement FCC, EASD, IDF,
ADA Sept 2007)
• HbA1c assay to be standardized
worldwide using the new IFCC standard
and expressed as:
– % as currently used (DCCT values)
– IFCC units in mmol HBA1c/mol HbA
– eAG in mmol/l or mg/dL (if ADAG study meets its data
acceptability goals)
• This paved the way for reporting both
HbA1c and EAG on lab reports
Diabetes Care and Diabetologia, 2007
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What Won’t Change…And What’s New
• To a clinician, there is no change in the
HbA1c assay
• To clinical chemists, there is a new IFCC
standard in the background
• We have the potential for a valuable
educational tool for patients
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A Typical Patient Encounter
“So, Mrs. Smith, it looks like you do
have diabetes. Your average blood
sugar is around 200. When people
don’t have diabetes, this number is
below 125. We need to work with
you to try to get this number, the
average glucose, down below 150
over the next few months with
some weight loss, exercise, and a
medication. Let’s talk some more
about what you can do…”
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A Typical Patient Encounter
“Wow, I’m not happy to hear
that…I know that diabetes
can do some bad things. Tell
me what I can do to get my
average glucose down.”
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What is ADA Doing to Promote
Use of eAG in Patient Care?
• Health care provider education
–
–
–
–
ADA Scientific Sessions, June ’08
American Association of Clinical Chemists, August ‘08
AADE Annual Meeting, August ‘08
eAG calculators (handheld and on professional.diabetes.org)
• Patient education
–
–
–
–
Website
Diabetes Forecast magazine, books
Pamphlets and brochures
ADA will include term “average glucose” in all consumer pieces
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What Can Clinicians and
Educators Do?
• Choose which term—A1C or Average Glucose—
to use with each patient (some may already be
used to A1C)
• In verbal communications, no need to say
“estimated”
• We want to keep the A in A,B,Cs
• Use updated table, calculator on
www.diabetes.org, or other tools to convert A1C
to average glucose
• “Lobby” your lab to report both numbers
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What Can Clinical Chemists Do?
• Even with tools, most clinicians will not take the
time to calculate conversions
• Reporting both HbA1c (DCCT-aligned) AND eAG
on lab reports will do the most to promote wide
use of the term
• Professional and patient education may drive
demand
• Conversion is a simple regression equation
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Average Glucose
Blood pressure
Cholesterol
to help make the “A” understandable!
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