An Evaluation of the Barriers to Patient use of Glucometer

6/18/2014
AADE14
ANNUAL MEETING & EXHIBITION
An Evaluation of the Barriers
to Patient use of Glucometer
Control Solutions: A Survey of
Patients, Pharmacists, and
Providers
AUGUST 6-9, 2014
ORLANDO, FL
Katherine S. O’Neal,
Pharm.D., MBA, BCACP,
CDE, BC-ADM, AE-C
Jeremy L. Johnson,
Pharm.D., BCACP,
CDE, BC-ADM
Diabetes Educator
The University of Oklahoma College of Pharmacy,
The University of Oklahoma School of Community Medicine:
OU Physicians Internal Medicine
Tulsa, OK
Diabetes Educator
The University of Oklahoma College of Pharmacy,
The University of Oklahoma School of Community Medicine:
OU Physicians Tulsa Family Medicine
Tulsa, OK
Overview
• The Importance of self-monitoring of blood glucose (SMBG)
and control solution
• Research
• Results and practice implications / opportunities
Presentation Objectives
• Describe the role of control solution
• Identify 1 pharmacy, patient and provider barrier each to
control solution usage
• Discuss provider, pharmacy and patient education
opportunities
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6/18/2014
Diabetes Standards of Care
For Glycemic Control
The Importance of SMBG and
Control Solution
• A1c
• Normal: 4.0-5.6%
• General Goal: < 7%
• Individualize
• SMBG values
• Normal: 70-100 mg/dL
• Fasting target: 70-130 mg/dL
• 2 hour post prandial target: < 180 mg/dL
ADA 2014 Standards of Care
Therapeutic Decision Making
• SMBG useful for:
• Evaluating responses to diet, exercise, or medications
• Preventing or treating hypoglycemia (patient safety)
• Making adjustments
• Medication (prandial insulin doses)
• Medical Nutrition Therapy
• Physical activity
Micro- and Macrovascular
Complications
• A1c < 7%
• ↓ microvascular complications (retinopathy, nephropathy,
neuropathy)
• DCCT and UKPDS
• If achieved soon after diagnosis, associated with longterm reduction in macrovascular disease
• DCCT, UKPDS, ACCORD, ADVANCE, VADT
• SMBG frequency correlated with lower A1c
• SMBG can facilitate achievement of goal A1c
ADA 2014 Standards of Care
Miller KM. Diabetes Care 2013;36:2009-2014
SMBG Indications and Frequency
• Dictated by patient specific needs / goals
• Patients using multiple-dose insulin or pump
• Check prior to meals and snacks, occasionally
postprandially, at bedtime, prior to exercise, when
suspect low, prior to critical tasks (driving)
• Patients using noninsulin regimen or basal
• Results may be helpful to guide treatment decisions
• For success, integrate results into clinical and selfmanagement plans
ADA 2014 Standards of Care
ADA 2014 Standards of Care
Miller KM. Diabetes Care 2013;36:2009-2014
Glucometer Accuracy
• Dependent on both the glucometer and user technique
• Monitor patient technique
• Monitor glucometer accuracy
• Glucometers are regulated by the FDA using guidelines from
the International Organization for Standardization (ISO)
• ISO 15197:2003
• Requires 95% results in range within +/- 20% true value
• ISO 15197:2013
• Requires 99% results in range within +/- 15% true value
ADA 2014 Standards of Care
ISO 15197:2003
ISO 15197:2013
AADE Practice Advisory Blood Glucose Meter Accuracy; September 16, 2013
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6/18/2014
Glucometer Accuracy
Role of Control Solution
• Many glucometers fall short of the ISO 2003 accuracy
standard of 95% +/- 20%
• 438 reports to FDA regarding glucometer errors*
• Incorrect display of SMBG results
• Incorrect glucose readings
• Many manufacturers fail to investigate incorrect glucose
readings due to the lack of control solution use by patient /
provider
• When control solution is applied to a test strip, a reading
out of range indicates a problem with either the
glucometer or the lot of test strips
*MAUDE FDA Manufacturer and User Facility Device Experience
AADE Practice Advisory Blood Glucose Meter Accuracy; September 16, 2013
Diabetes Technol Ther. 2010;12(3):221-31
Melker RJ. Diabetes Care 2003;26(11):3190
• Manufacturer recommendations:
• Use control solution to confirm proper function of
glucometer and lot of test strips when there is a
suspected error or malfunction of either
• Use control solution when either a new glucometer or
new vial of test strips is used
Chaudhry T. Diabetes Educ. 2013;39(5):689-95.
Is it being used?
• Chaudhry and Klonoff
• Purpose: Determine prevalence of control solution use in
patients who perform SMBG
• Methods:
• 18 patients with type 1 diabetes surveyed to measure
knowledge and usage of control solution
• Determined availability of control solution in all
pharmacies in San Mateo County, California
• Results:
• 82% patients had knowledge of control solution
• 58% patients never use it (only 26% use it as intended)
• Only 15% of pharmacies stocked it
Research
Chaudhry T. Diabetes Educ. 2013;39(5):689-95.
Research Objective
Primary Outcomes
• Identify potential barriers to control solution use from multiple
perspectives including patient, pharmacy and provider
• Patient utilization of control solution
• Determine whether patient demographic factors influence
the use of control solution
• Barriers to control solution use
• Determine availability of control solution in a sampling of
community pharmacies
• Identify whether patient, pharmacist, or prescriber
perceptions of control solution use may influence proper
use
• Identify whether the type of clinic or level of provider
influences use of control solution
Project was IRB approved
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6/18/2014
Setting and Sample
Patients:
• Type 1 and type 2 diabetes
• Academic health system:
• Internal Medicine
• Family Medicine
• General Pediatrics
• Specialty Diabetes Pediatrics
Providers:
• Physicians (faculty and residents) in the respective clinics
Pharmacies:
• Community and independent pharmacies in the Tulsa, OK
metropolitan area
Study Design
• Prospective, observational survey design
• Pharmacy environmental audit
Phase 1
• Pharmacist telephone interview
Phase 2 • Patient telephone interview
Phase 3
Pharmacy Selection
• Environmental Audit
• Tulsa, OK divided into 5 geographical sections (North,
South, East, West, and Central)
• 4 chain and 1 independent pharmacy randomly selected
from a master list of pharmacies located in each
geographical section
• Audit guide:
• Location of control solution (if visible) and available
brands
• 1 investigator visited each pharmacy for an on-site audit
for visible presence of control solution
Pharmacist
• Pharmacist from each of the 25 stores audited were
interviewed via telephone
• Telephone interview script:
• Knowledge of control solution
• Perception of use and recommendation habits
• Availability and brands
• Location
• Ordering process
• Insurance coverage
Patient Selection
• Institution’s electronic medical record system used to
generate a report for each clinic identifying patients with type
1 or type 2 diabetes
• 15 patients randomly selected from each clinic and screened
for inclusion eligibility:
• ‘Active’ patient within the clinic
• Diabetes diagnosis for at least 1 year
• Utilize SMBG at least once a week
• Provider web-based survey
Patient Telephone Script
•
•
•
•
•
•
•
•
•
Frequency of SMBG and perception of importance
Glucometer brand
Pharmacy
Control solution knowledge, use / barriers, recommendation
and perception
Received diabetes education
Works with CDE or specialist
Medication usage
Perception of diabetes control and obtaining A1c
Demographics (age, years diagnosed, insurance, type of
diabetes, clinic, and A1c)
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6/18/2014
Provider Selection
• All faculty and medical residents in each clinic emailed a
brief explanation of survey along with the web link with 2weeks to complete
• Web-based survey created using Qualtrics:
• Knowledge and perception of control solution
• Practice habits and frequency of recommendation
• Clinic
• Level of provider
Results
Pharmacy Audit
Visible Control Solution
Visual Inspection of Pharmacies
No
Independent
Yes
Retail
0
5
10
15
20
Number of Pharmacies (n=25)
Only 1 of the 25 pharmacies audited had
visible control solution
Control Solution Knowledge,
Perception, and Use
100% were
familiar with
control
solution
Pharmacist Survey
Reasons:
• Not a high
priority
• Patients
never ask
• Time
constraints
• Not
stocked
61% feel
usage should
be routine
practice
14% always
recommend it
43%
recommend
only in certain
situations
43% never
recommend
n=23
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6/18/2014
Stocks Control Solution
39%
• 29% (4) state
there is no
demand
61%
• 36% (5) don’t
know or had
misunderstanding
Yes
• 56% (5) stock it behind
the pharmacy counter
• 33% (3) ‘stock it’ with
the OTC diabetes
supplies
• 11% (1) didn’t know
Patient Survey
No/Don't Know
87% (20) state they can order if the patient asks
Demographics
•
•
•
•
•
Diabetes History
15 patients from each of the 4 clinics (n=60)
43% (26) type 1 and 57% (34) type 2
Age range 6-94 (mean 36 yoa)
30% (18) patients pediatrics and 70% (42) adults
Insurance coverage
• Medicaid / Medicare 62% (37)
• Private 33% (20)
• Self-pay 5% (3)
• Years with diagnosis
• 1-9 years = 57% patients (34)
• 10-20 years = 33% patients (20)
• 21 yrs or longer = 10% patients (6)
• Level of diabetes control
• < 7% = 28% (17)
• ≥ 7% = 72% (43)
• 72% of patients (43) received formal diabetes education
Perceived Importance of SMBG
2%
Control Solution Knowledge and
Use
45% (14)
patients use
control solution
Yes
No
48%
52%
57% (8) use an
independent
pharmacy
98%
not aware
aware
using if aware
Only 14 (23%) of the 60 patients use control solution
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6/18/2014
Patient Characteristics
30
26%
Formal Diabetes Education
Use
25
Don't Use
31%
20
70%
Don't Use
15
17%
10
Use
100%
30%
Don't Use
P=0.7
80%
5
61%
60%
0
1-9 yrs
10-20 yrs
Years with diagnosis
(p=0.9)
≥ 21 yrs
83%
Use
20%
0%
39%
Pediatric
2-3 times/day
1 time/day
21%
40%
60%
Received education
Level of Diabetes Control
22% use
Control
Solution 30%
77%
18%
17%
20% use
Control
Solution
82%
53%
Use
100%
Did not receive education
74%
23%
80%
Adult
Testing Frequency
26%
20%
17%
0%
≥ 4 times/day
79%
40%
0%
20%
Don't Use
40%
60%
80%
100%
< 7%
• Of the patients testing 4+ times/day, 19 are type 1 (6 use control
solution) and 4 are type 2 (0 use control solution)
• 3 of the 4 type 2 patients using control solution, see a CDE
Insurance
≥ 7%
25% use
Control
Solution
No A1c documented
Clinic
7% use Control
Solution
100%
90%
5%
80%
70%
60%
21% use
Control
Solution 34%
80%
60%
73%
93%
50%
40%
30%
20%
10%
Medicaid/Medicare
Private
Self-Pay
61%
72% use
Control
Solution
40%
20%
27%
7%
0%
Internal Medicine
Pediatrics
Use
Diabetes Pediatrics Family Medicine
Don't use
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6/18/2014
Control Solution Usage
• 67% (31) don’t
use because
they don’t
know about it
(p=0.05)
Type 1
38%
77%
Provider Survey
P=0.03
23%
Type 2
15%
• 28% (13) lack
understanding
• 2% (1) stated
pharmacy
doesn’t stock
Don't Use
Use
Demographics
Provider Type
Number
Resident
13
Faculty
18
Endocrinologist
1
Clinic
Number
Family Medicine
13
Internal Medicine
8
Pediatrics
8
Pediatric Diabetes
1
Med/Peds
2
Provider Survey
Reasons:
• Not sure
needed with
new technology
• Use a clinic
glucometer to
compare
against for
accuracy
• Don’t think
about it
62% were
familiar with
control solution
50% feel usage
should be
routine practice
56%
recommend
44% never
recommend
n=29
Knowledge and Use by Clinic
Knowledge and Use by Provider
Clinic
Recommend
Patient knowledge Patient use of CS
using CS (p=0.2) of CS (p=0.04)*
(p=0.2)
Provider Type
Recommend using CS (p=0.5)
Family
Medicine
13% (1)
Resident
15% (2)
Faculty
27% (4)
Internal
Medicine
80% (4)
73% (11)
20% (3)
Endocrinologist
100% (1)
Pediatrics
25% (1)
40% (6)
27% (4)
Pediatric
Diabetes
100% (1)
67% (4)
40% (6)
CS: Control Solution
27% (4)
7% (1)
CS: Control Solution
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6/18/2014
Opportunities for Educators
Implications
• Pharmacists may have lack of understanding of importance
or ‘logistics’ of control solution
• Pharmacies are not visibly stocking control solution
• Patients may have lack of understanding of importance or
may not know where to purchase
• Providers may have a lack of understanding of importance
• Is there a difference between pediatric vs. adult
populations?
• Is there a difference between type1 vs. type 2 patients?
What Ideas Do You Have???
AADE14
ANNUAL MEETING & EXHIBITION
AUGUST 6-9, 2014
ORLANDO, FL
References
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Miller KM, Beck RW, Bergenstal RM, et al. T1D Exchange Clinic Network. Evidence of a strong association between
frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D Exchange clinic registry participants.
Diabetes Care 2013;36:2009–2014
International Organization for Standardization. Standard 15197. In vitro diagnostic systems – requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus. Accessed from
http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1749. October 28, 2013.
International Organization for Standardization. Standard 15197:2013. In vitro diagnostic systems – requirements for
blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Accessed from
http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1749. October 28, 2013.
America Association of Diabetes Educators. Practice Advisory: Blood Glucose Meter Accuracy; issued September 16,
2013. Accessed from
http://www.diabeteseducator.org/export/sites/aade/_resources/pdf/research/Practice_Advisory_BGM_FINAL.pdf
US Food and Drug Administration MAUDE Database [online]. Available from
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextResults.cfm. Accessed September 2013
Freckmann G, Baumstark A, Zschornack E, et al. System accuracy evaluation of 27 blood glucose monitoring systems
according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31
Melker RJ. Test strips for blood glucose monitors are not always accurate. Diabetes Care 2003; 26(11):3190
Chaudhry T, Klonoff DC. SMBG out of control: the need for educating patients about control solution. Diabetes Educ.
2013 Sep-Oct;39(5):689-95. doi: 10.1177/0145721713495791. Epub 2013 Jul 29.
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