an evaluation of the barriers to patient use of glucometer ... · glucometer accuracy • many...

6/18/2014

1

AADE14ANNUAL MEETING & EXHIBITION AUGUST 6-9, 2014ORLANDO, FL

An Evaluation of the Barriers to Patient use of Glucometer

Control Solutions: A Survey of Patients, Pharmacists, and

Providers

Katherine S. O’Neal, Pharm.D., MBA, BCACP, CDE, BC-ADM, AE-CDiabetes Educator The University of Oklahoma College of Pharmacy, The University of Oklahoma School of Community Medicine: OU Physicians Internal MedicineTulsa, OK

Jeremy L. Johnson, Pharm.D., BCACP, CDE, BC-ADMDiabetes Educator The University of Oklahoma College of Pharmacy, The University of Oklahoma School of Community Medicine: OU Physicians Tulsa Family MedicineTulsa, 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

6/18/2014

2

The Importance of SMBG and Control Solution

Diabetes Standards of CareFor Glycemic Control

• 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

• SMBG frequency correlated with lower A1c

ADA 2014 Standards of CareMiller KM. Diabetes Care 2013;36:2009-2014

Micro- and MacrovascularComplications

• A1c < 7%• ↓ microvascular complications (retinopathy, nephropathy,

neuropathy)• DCCT and UKPDS

• If achieved soon after diagnosis, associated with long-term reduction in macrovascular disease

• DCCT, UKPDS, ACCORD, ADVANCE, VADT

• SMBG can facilitate achievement of goal A1c

ADA 2014 Standards of CareMiller 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 self-management plans

ADA 2014 Standards of Care

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 CareISO 15197:2003ISO 15197:2013AADE Practice Advisory Blood Glucose Meter Accuracy; September 16, 2013

6/18/2014

3

Glucometer Accuracy• 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

*MAUDE FDA Manufacturer and User Facility Device ExperienceAADE Practice Advisory Blood Glucose Meter Accuracy; September 16, 2013Diabetes Technol Ther. 2010;12(3):221-31Melker RJ. Diabetes Care 2003;26(11):3190

Role of Control Solution• 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

• 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

Chaudhry T. Diabetes Educ. 2013;39(5):689-95.

Research

Research Objective• Identify potential barriers to control solution use from multiple

perspectives including patient, pharmacy and provider

Project was IRB approved

Primary Outcomes• 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

6/18/2014

4

Setting and SamplePatients:• 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 clinicsPharmacies:• Community and independent pharmacies in the Tulsa, OK

metropolitan area

Study Design• Prospective, observational survey design

Phase 1• Pharmacy environmental audit

Phase 2• Pharmacist telephone interview• Patient telephone interview

Phase 3• Provider web-based survey

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

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)

6/18/2014

5

Provider Selection• All faculty and medical residents in each clinic emailed a

brief explanation of survey along with the web link with 2-weeks 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

Visual Inspection of Pharmacies

0 5 10 15 20

Yes

No

Independent

Retail

Number of Pharmacies (n=25)

Visi

ble

Con

trol S

olut

ion

Only 1 of the 25 pharmacies audited had visible control solution

Pharmacist Survey

Control Solution Knowledge, Perception, and Use

100% were familiar with

control solution

61% feel usage should

be routine practice

14% always recommend it

43% recommend

only in certain situations

43% never recommend

n=23

Reasons:• Not a high

priority• Patients

never ask• Time

constraints• Not

stocked

6/18/2014

6

Stocks Control Solution

39%

61%

Yes No/Don't Know

• 56% (5) stock it behind the pharmacy counter

• 33% (3) ‘stock it’ with the OTC diabetes supplies

• 11% (1) didn’t know• 29% (4) state

there is no demand

• 36% (5) don’t know or had misunderstanding

87% (20) state they can order if the patient asks

Patient Survey

Demographics• 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)

Diabetes History• 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

98%

2%

Yes

No

Control Solution Knowledge and Use

48%

45% (14) patients use

control solution

57% (8) use an independent

pharmacy

52%

not aware using if awareaware

Only 14 (23%) of the 60 patients use control solution

6/18/2014

7

Patient Characteristics

39%17%

61%83%

0%

20%

40%

60%

80%

100%

Pediatric Adult

Use Don't Use

0

5

10

15

20

25

30

1-9 yrs 10-20 yrs ≥ 21 yrs

Use

Don't Use31%

17%

26%

Years with diagnosis (p=0.9)

Formal Diabetes Education

79%

70%

21%

30%

0% 20% 40% 60% 80% 100%

Use

Don't Use

Received education Did not receive education

P=0.7

Testing Frequency

18%

23%

26%

82%

77%

74%

0% 20% 40% 60% 80% 100%

1 time/day

2-3 times/day

≥ 4 times/day

Use Don't Use

• 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

Level of Diabetes Control

17%

53%

30%

< 7% ≥ 7% No A1c documented

22% use Control Solution



Insurance

61%

34%

5%

Medicaid/MedicarePrivateSelf-Pay




Clinic

20% 27%40%

7%

80% 73%60%

93%

0%10%20%30%40%50%60%70%80%90%

100%

Internal Medicine Pediatrics Diabetes Pediatrics Family Medicine

Use Don't use

6/18/2014

8

Control Solution Usage

77% 23%

Don't Use Use

Type 1 38%

Type 2 15%

• 67% (31) don’t use because they don’t know about it (p=0.05)

• 28% (13) lack understanding

• 2% (1) stated pharmacy doesn’t stock

P=0.03 Provider Survey

Demographics

Clinic NumberFamily Medicine 13Internal Medicine 8Pediatrics 8Pediatric Diabetes 1Med/Peds 2

Provider Type NumberResident 13Faculty 18Endocrinologist 1

Provider Survey

62% were familiar with

control solution

50% feel usage should be

routine practice

56% recommend

44% never recommend

n=29

Reasons:• Not sure

needed with new technology

• Use a clinic glucometer to compare against for accuracy

• Don’t think about it

Knowledge and Use by Clinic

Clinic Recommend using CS (p=0.2)

Patient knowledge of CS (p=0.04)*

Patient use of CS (p=0.2)

Family Medicine

13% (1) 27% (4) 7% (1)

Internal Medicine

80% (4) 73% (11) 20% (3)

Pediatrics 25% (1) 40% (6) 27% (4)Pediatric Diabetes

100% (1) 67% (4) 40% (6)

CS: Control Solution

Knowledge and Use by Provider

CS: Control Solution

Provider Type Recommend using CS (p=0.5)Resident 15% (2)Faculty 27% (4)Endocrinologist 100% (1)

6/18/2014

9

Implications

Opportunities for Educators• 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???

AADE14ANNUAL MEETING & EXHIBITION AUGUST 6-9, 2014ORLANDO, FL

References• 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 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.

• 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.

an evaluation of the barriers to patient use of glucometer ... · glucometer accuracy • many...

Documents