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Home Blood Pressure Monitoring and Diabetes

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					                                        P R A C T I C A L                P O I N T E R S




        Home Blood Pressure Monitoring and Diabetes
                                      John R. White, Jr., PharmD, PA-C, and Jason Schick, PharmD




                                                    Several trials have also demonstrated   HBPM for patients with type 2 diabetes

H
         ome blood pressure monitoring
         (HBPM) may be useful in the           the importance of blood pressure–lower-      and hypertension and states that,
         management of many patients           ing in hypertensive patients with dia-       “Patients with type 2 diabetes and
with hypertension and diabetes. Blood          betes. Two of the most significant of        hypertension should monitor their blood
pressure monitoring traditionally has          these trials were the United Kingdom         pressure frequently with home blood
been carried out in providers’ offices.        Prospective Diabetes Study (UKPDS)           pressure self-monitoring.”6
However, many patients visit their             and the Hypertension Optimal Treatment
providers only once or twice a year,           (HOT) study. The HOT study reported a        Potential Benefits
which limits their ability to monitor          51% reduction in cardiac events in the       As is evident from the paragraph above,
hypertension. Over the past several            diabetes subpopulation (n = 1,501) who       the role of HBPM in the diagnosis and
years, HBPM technology has evolved to          were randomized to the more intensive        treatment of hypertension is not yet fully
a point where accuracy and ease of use         blood pressure arm (goal: diastolic blood    delineated. Potential benefits of HBPM
now make this form of monitoring feasi-        pressure of 80 vs. 90 mmHg).2 The            include distinguishing sustained hyper-
ble and useful in many cases.                  UKPDS reported significant reductions        tension from white-coat hypertension,
     This evolution has been similar in        in its intensive blood pressure arm (mean    assessing response to antihypertensive
some ways to that of blood glucose             result: 144/82 vs. 154/87 mmHg in the        medication, improving adherence to
meters. When relatively accurate and           standard arm) in all diabetes-related end-   treatment, and potentially reducing
easy to use blood glucose monitors were        points, deaths, stroke, and microvascular    costs. The World Health Organization–
first produced, their role was a subject of    endpoints.3                                  International Society of Hypertension
debate. Today, they are widely accepted             Currently, the American Diabetes        Guidelines acknowledge most of these
as a standard part of care. Whether            Association (ADA) recommends a blood         potential benefits with the exception of
HBPM will follow a similar course              pressure goal of < 130/80 mmHg.4 The         cost reduction.7
remains to be seen.                            seventh report of the Joint National              White-coat hypertension, also known
     This article provides a brief overview    Committee on Prevention, Detection,          as “isolated office hypertension,” is a
of methods of blood pressure measure-          Evaluation, and Treatment of High            condition in which otherwise normoten-
ment, recommendations from expert              Blood Pressure (JNC 7) also recom-           sive patients have consistently elevated
groups on the use of this technology,          mends a blood pressure goal of < 130/80      blood pressure during medical office vis-
potential benefits and problems, and a         mmHg for patients with diabetes.5            its.7,8 Most patients treated for hyperten-
review of some of the more useful                                                           sion who have persistently high office
devices.                                       HBPM Recommendations                         readings also have high out-of-office
                                               The ADA is neutral on the issue of           readings.8 However, the potential for
Diabetes and Hypertension                      HBPM and does not mention it in the          increased cardiovascular risk in patients
Individuals with diabetes are at great         position statement “Standards of             with white-coat hypertension is still
risk for cardiovascular disease. Part of       Medical Care for Patients With Diabetes      being debated. Studies have demonstrat-
this increased risk is because of hyper-       Mellitus.”4 JNC 7 suggests that HBPM         ed a link between white-coat hyperten-
tension. There is a very high incidence        may benefit patients by providing infor-     sion and carotid artery atherosclerosis,
of hypertension in patients with dia-          mation on response to antihypertensive       changes in left ventricular structure, and
betes. One survey estimated that 54.8%         medication, improving compliance with        endothelial function.9–11
of Caucasians, 60.4% of African                therapy, and evaluating “white-coat               The American Society of Hyperten-
Americans, and 65.3% of Mexican                hypertension”5 (discussed below). The        sion suggests using HBPM as a screen-
Americans who had diabetes also had            American Association of Clinical             ing test for white-coat hypertension.12 If
hypertension.1                                 Endocrinologists strongly recommends         a normal blood pressure is found at


28                                                                                            Volume 22, Number 1, 2004 • CLINICAL DIABETES
                                                P R A C T I C A L             P O I N T E R S




home, it should be confirmed by ambu-               Potential savings from the use of            aneroid monitor possesses drawbacks
latory monitoring. If a high blood pres-            HBPM have not yet been evaluated ful-        similar to the mercury sphygmo-
sure is found, no further testing is need-          ly in clinical trials but include reduc-     manometer because a stethoscope must
ed and treatment should be initiated.               tions in costs of medication for patients    be used to recognize the Korotkoff
Because of its high specificity and rea-            with white-coat hypertension, less need      sounds. The aneroid monitor uses a
sonable cost, HBPM may also be appro-               for clinic visits, and, possibly, reduc-     mechanical bellow and lever system that
priate for the long-term follow-up of               tions in costs associated with cardiovas-    can require frequent calibration to pro-
patients with white-coat hypertension.              cular morbidity.12,13                        duce consistent and accurate readings.
Unfortunately, the question of whether                                                           Aneroid monitors are less expensive,
patients with white-coat hypertension               Monitors for Home Use                        but also less accurate, than mercury
should be treated remains unanswered.               There are four different configurations      sphygmomanometers.16
     HBPM clearly can be useful in                  of blood pressure monitors for home               The last major two HBPM devices
assessing response to antihypertensive              use: the mercury sphygmomanometer,           are digital, with either semi-automatic or
therapy and may allow for more rapid                the aneroid manometer, and semiauto-         completely automatic inflatable cuffs.
titration to goal. It can be used to ensure         matic manual-inflation or automatic-         The blood pressure reading is displayed
adequate blood pressure control across              inflation digital devices. The majority of   on an easy-to-read screen that is also
the drug-dosing intervals during awake              patients probably should be encouraged       available in large formats for patients
hours. HBPM may be used to evaluate                 to choose a digital monitor. These sys-      with visual impairment. Digital monitors
effects of increasing or decreasing doses           tems are accurate, easy to use, and asso-    almost exclusively use oscillometric
of antihypertensive agents during titra-            ciated with less user error. Automated       measurement, in which small oscilla-
tion. It may also be used to evaluate the           monitors offer both simplicity and ease      tions or changes in cuff inflation pres-
relation of blood pressure levels to sus-           of use for patients who lack the techni-     sure are used to obtain the mean systolic
pected or possible side effects of therapy          cal skills required to properly use the      and diastolic pressure and, in some cas-
(hypotension).                                      more sophisticated monitors.                 es, pulse. There is a great degree of con-
     HBPM may increase adherence to                      The device with the longest history,    sistency between auscultation readings
pharmacological and nonpharmacologi-                first invented back in 1733, is a standard   obtained by practitioners and oscillomet-
cal interventions. Hypertension is a                mercury sphygmomanometer. The repu-          ric devices.12 The cost of a digital blood
silent disease, often without signs or              tation of the mercury sphygmomano-           pressure monitor depends on the features
symptoms, and this technology can pro-              meter in clinical settings would seem to     it offers. Extra large displays, printers,
vide tangible signs of disease control. It          recommend it for home use. Unfortu-          pulse readings, and voice-announced
may increase patients’ participation in             nately, a number of contributing factors     readings are some of the optional avail-
their own care and possibly help them               usually make it impractical for use at       able features.
cope with the disease. In general, it may           home. The mercury sphygmomanometer                In addition to arm band monitors,
improve their adherence.                            is composed of a glass tubular gauge, a      there are also wrist and finger models.
     HBPM can provide a simple and                  reservoir of mercury, and a manually         Although convenient, the finger monitor
cost-effective means of obtaining a large           inflated cuff. Because it uses gravity to    has not been proven to produce accurate
number of blood pressure readings. A                measure blood pressure, the readings are     blood pressure readings. The device
study of 200 patients randomized to                 usually consistent and accurate. As the      occludes a digital artery in the finger to
either usual care or home monitoring in             cuff inflates, back sound pressure causes    calculate blood pressure. Because the
a closed model health maintenance                   the mercury to rise. The Korotkoff           peripheral blood vessels are susceptible
organization found that self-measure-               sounds are observed by auscultation with     to vasoconstriction, the use of a finger
ment of blood pressure may be cost-                 a stethoscope.15 Many patients do not        monitor is not recommended. Another
effective. At the end of 1 year, the costs          possess the skills and dexterity required    factor that influences both finger and
of care were 29% lower in the self-moni-            to use a mercury blood pressure monitor      wrist monitors is position of the limb.
toring group, and blood pressure was                at home. Because of the toxicity of mer-     Wrist monitors have improved, but their
equally well controlled in both groups.13           cury, the U.S. Environmental Protection      readings are dependent on the position
     However, widespread use of HBPM                Agency is in the process of mandating        of the arm. Because of these issues, it is
could be costly. One group estimated                that mercury sygmomanometers be              probably most reasonable to recom-
that the costs of routine use of HBPM               phased out.                                  mend an arm monitor and to stress the
on all 50 million people with hyperten-                  The aneroid sygmomanometer is the       importance of having a large enough
sion in the United States would be $2.5             second type of HBPM device. This             cuff based on the device manufacturer’s
billion.14 This figure assumes that there           meter is composed of a numbered dial         recommendations and patients’ arm
would be no savings from HBPM.                      and manually inflatable cuff. The            measurements.


CLINICAL DIABETES • Volume 22, Number 1, 2004                                                                                           29
                                       P R A C T I C A L               P O I N T E R S




Accuracy                                     HEM 737 with Intellisense.                   the cuff design to enable the cuff to mold
The greatest barrier that HBPM device            The market is flooded with HBPM          itself better to a user’s arm. The Easycuff
manufacturers have had to overcome is        device manufacturers offering closely        system can record a blood pressure and
the questionable accuracy of these prod-     competitive products. These products         pulse rate reading without interference
ucts. This industry historically has         continue to change with respect to the       from any type of irregular heartbeat. The
lacked strict guidelines for manufactur-     variety of functions and, therefore,         Wall Street Journal recently named this
ing processes and overall performance.       degree of complexity. Providers should       monitor best overall.22
A device can give inaccurate data for        stress the crucial importance of accuracy
many reasons. However, operator error        as the primary goal for patients’ device     Patient Information
and device malfunctions are the most         selection.                                   Patients who begin using HBPM should
common. An occasional reading of ±5              The sheer number of products avail-      be instructed on proper technique.
mmHg has never proven to be clinically       able can cause patients understandable       Generally speaking, the automated sys-
significant and is usually considered        confusion and afford pharmacists and         tems are easier for patients to master.
acceptable.                                  care providers the opportunity to provide    Patients should have an understanding
    Before the Association for the           their patients with sound information        of what their goal blood pressure is and
Advancement of Medical Instrumenta-          before they buy a monitor. Most patients     when to be concerned about a high or
tion (AAMI) standards were applied to        will purchase monitors from retail phar-     low reading. Patients should also under-
blood pressure devices, many of these        macies where they can seek the advice        stand that their blood pressure will fluc-
products were inaccurate. The govern-        and assistance of pharmacy staff. Inter-     tuate. Finally, they should be advised to
mental regulatory group responsible for      net-based medical device retailers are       bring their meters to their medical
the HBPM device sector is the Food and       another common venue for purchasing          appointment to have them tested against
Drug Administration (FDA).16,17 The          monitors.                                    an office standard.
FDA uses the AAMI standards as the               Data gathered by Information                 It is probably also useful to help
American national standards.                 Resources, Inc., showed that at least        patients determine a regular testing
    A device expected to be sold or dis-     65% of HBPM devices in the United            schedule. The ad hoc panel of the Ameri-
tributed in the United States should meet    States are sold by Omron Healthcare          can Society of Hypertension recom-
AAMI standards. However, a manufac-          Corporation.19 Along with Omron, man-        mends that patients take at least a single
turer can still market a device without      ufacturers such as A & D Medical Life-       or double reading in the morning and
evidence that it has passed the AAMI         Source, Lumiscope, Mark of Fitness,          evening. When assessing the influence of
standards because testing is not required.   Panasonic, Samsung, and many others          work-related stressors into blood pres-
The manufacturer is prohibited only          are producing high quality, clinically       sure management, patients should be
from making claims about accuracy if         tested monitors for home use.                encouraged to take readings on both
their device has not been tested and             A recent Consumer Reports article        work and non-work days of the week.
shown to meet AAMI standards. Patients       tested 16 of the top-selling home moni-
can protect themselves from inferior         tors. The number one recommended             Conclusions
products by purchasing only monitors         automatic inflation monitor was the          HBPM technology has advanced in
bearing the AAMI seal.                       Omron Intellisense HEM-711AC,                recent years such that affordable, sophis-
    The most rigorous testing to date        which can detect irregular heartbeats in     ticated, accurate, and easy to use auto-
was conducted by the Working Group on        addition to accurate blood pressure.20       mated systems are now available.
Blood Pressure Monitoring of the Euro-       The Intellisence monitors have incorpo-      Incorporation of this technology into the
pean Society of Hypertension (ESH)           rated design technology known as             therapeutic plans of patients with dia-
using two of the most popular protocols:     “fuzzy logic,” which is potentially capa-    betes and hypertension may be benefi-
the AAMI standards and the British           ble of calculating an anticipated systolic   cial. HBPM may increase patients’
Hypertension Society (BHS) protocol.18       blood pressure so as to keep over-infla-     adherence to therapeutic plans, facilitate
The ESH group classified devices as          tion of the cuff to a minimum. This fea-     titration of pharmacological regimens,
“recommended,” “questionable recom-          ture has reduced the level of discomfort     and reduce patients’ overall health care
mendation,” or “not recommended.” Of         often associated with high cuff pres-        costs.
23 devices tested, only five received the    sures and is now integrated by most
ESH recommended rating. These moni-          manufacturers.                                             REFERENCES
tors, which all use the upper arm for            The latest A & D Medical LifeSource
monitoring, are Omron HEM 705-CP,            home monitor, model #UA-787, intro-             1
                                                                                               Harris M: Racial and ethnic differences in
Omron HEM 722 C, Omron HEM                   duces the Easycuff system.21 It features a   health care access and health outcomes for adults
                                                                                          with type 2 diabetes. Diabetes Care
735C, Omron HEM 713C, and Omron              semi-rigid plastic component added to        244:454–459, 2001



30                                                                                          Volume 22, Number 1, 2004 • CLINICAL DIABETES
                                                P R A C T I C A L                  P O I N T E R S




    2
      Hansson L, Zanchetti A, Carruthers SG,        ular structure and function in patients with white   Evaluation: Use of standards in substantial equiv-
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     U.S. Department of Health and Human Ser-       Hunkeler EM, Hurley LB, Tekawa IS, Vogt TM:              22
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express.pdf )                                       pressure monitoring and blood pressure self-         John R. White, Jr., PharmD, PA-C, is a
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nologists: Medical guidelines for the manage-       hypertension. Ann Intern Med 118:867–882,            professor and vice-chairman of research
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                                                        15
                                                           Beevers G, Lip GY, O’Brien E: ABC of          at Washington State University College
2002                                                hypertension: blood pressure measurement. Part
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    7
      Chalmers J, MacMahon S, Mancia G, Whit-       of auscultatory blood pressure measurement.          Schick, PharmD, is a private consultant
worth J, Beilin L, Hansson L, Neal B, Rodgers A,    BMJ 322:1043–1047, 2001
Mhurchu CN, Clark T: 1999 World Health Orga-                                                             in Spokane, Wash.
                                                        16
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Hypertens 17:151–183, 1999                          Devices and Radiologic Health, Office of Device      Note of disclosure: Dr. White has
                                                    Evaluation: Non-invasive blood pressure (NIBP)
   8
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Wilkins, 1998                                                                                            ments from Omron Healthcare Corp.,
                                                        17
                                                           U.S. Department of Health and Human Ser-      which manufactures home blood pres-
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    Muscholl M, Hense H, Brockel U, Doring A,
Riegger G, Schunkert H: Changes in left ventric-    Devices and Radiologic Health, Office of Device      sure monitoring devices.




CLINICAL DIABETES • Volume 22, Number 1, 2004                                                                                                           31

				
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