DIABETES TECHNOLOGY & THERAPEUTICSVolume 3, Number 4, 2001© Mary Ann Liebert, Inc.

The Future of Sensor Technologies in Diabetes: Impacton Healthcare Delivery

MEGHNA CHOWDARY, B.S.

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Health Technology Center, San Francisco, California.

Commentary

INTRODUCTION

THE HEALTH TECHNOLOGY CENTER (HealthTech)recently convened scientists, developers,

and clinical users of sensor technologies to ex-amine how these emerging technologies will impact healthcare delivery in the future.HealthTech’s research explored the staging andlikely timing of market entry for these tech-nologies and their impact. HealthTech’s ExpertPanel projected that the effect of sensor tech-nologies on diabetes could potentially reducehospital admission rates for hypoglycemia byup to 50% and those for diabetic ketoacidosis by15%. While this considerable reduction is not ex-pected to be realized for several years, health de-livery systems are closely following the devel-opment of sensor-based diabetes products toprepare for their impact.

HealthTech is an independent, nonprofit re-search organization that produces forecasts forhospitals, delivery systems, and health plansabout emerging technologies that are expectedto have a significant impact on healthcare de-livery in the future. As the pace of introductionof new technologies accelerates, health deliv-ery systems are challenged to adopt and deploythese innovations effectively, while simultane-ously addressing aging facilities, inadequateinformation systems, and rising concerns aboutthe quality and cost of healthcare. Delivery sys-tems and health plans face this bulging pipeline

of medical products and services under devel-opment with few impartial sources of infor-mation and almost no evaluation of the poten-tial effects of each technology. HealthTechworks to satisfy this need for accurate and un-biased forecasting information through com-prehensive, independent research and the pub-lication of information about new technologies.HealthTech’s members include many well-rec-ognized delivery systems and plans, such asVHA Inc., Premier, Inc., Kaiser Permanente,Sutter Health, Mills-Peninsula Health Services,WellPoint Health Networks, Ascension Health,Providence Health System, and Group HealthCooperative. (For more information on theHealth Technology Center, please visit www.healthtechcenter.org.)

HealthTech’s research methodology is adaptedfrom existing technology assessment and fore-casting methods and is composed of literaturereviews, expert interviews, developer reviews,stakeholder analyses, expert panels, and fore-cast reports. In June 2001, HealthTech conveneda panel of experts in sensors for monitoring todiscuss the impact of this technology on health-care. The panel considered a broad range of sen-sor technologies targeting several diseases andconditions, and the projected effect on diabeteswas among the most extensive. This article isbased upon the forecasts derived from the ex-pert panel, interviews, and report, Sensors forMonitoring.

For the purposes of this article, sensors aredefined as devices that are able to detect achange in physical, biological, or chemicalproperties or events and produce signals capa-ble of analysis. Initially employed in the man-ufacturing industries, sensor technologies en-tered the healthcare arena in the mid-1970swith the commercialization of the first glucosemonitor. Even today, nearly 90% of the biosen-sor industry remains dedicated to researchingalternate methods of glucose sensing. The ad-vantage of sensor technologies in glucose mon-itoring is the ability of sensors to enhance therapidity, accuracy, and stability of measure-ments. The future of sensors in diabetes carelies in the capacity of the technology to achievelong-term continuous measurement, allowingassessment of daily, weekly, and monthlytrends, more precise control, and the preven-tion of acute and chronic complications of thedisease. Diabetes is unique among all illnessesfor the extent to which the complications havebeen studied and effective interventions andmanagement methods established. With theDCCT study and other trials demonstrating theclinical importance of tight glycemic control,the clinical effectiveness of sensor-based tech-nologies can be relatively easily and clearlydemonstrated.

HealthTech asked the expert panel to exam-ine the probable staging of specific sensor-based devices. Because these are forecasts, it isimportant to point out that the most significantaspects of the expert panel’s statements abouttimelines are the direction of trends and prob-able sequencing of events, as specific dates willshift due to environmental factors, drivers, bar-riers, and wildcard events (1).

HealthTech’s expert panel anticipated thatthe next generation of noninvasive continuousglucose monitors acceptable to clinicians forautonomous use from fingersticks will enterthe market in the next two to five years. In ad-dition, implantable glucose monitors thatrecord glucose levels for extended periods of time will be available within five years.HealthTech’s expert panel expected that issuesof biocompatibility, stability, and accuracy inimplantable sensors will be resolved to permitthe development of devices capable of long-term monitoring. The panel estimated impacts

on delivery systems based on their expectationsthat the artificial pancreas will be in clinical use within 10 years, combining technologicalprogress in smart sensors, insulin delivery, andbiocompatible materials. The smart sensor, asystem that continuously monitors a value (sig-nal) and initiates a therapeutic response whenvalues fall outside of set limits, will control thefeedback mechanism required to create aclosed-loop insulin delivery device.

IMPACT ON QUALITY OF CARE

A growing emphasis on quality and consis-tency in care and outcomes is evident in thehealthcare system, with an accompanyingsearch for evidence-based therapeutic ap-proaches. The recent Institute of Medicine re-ports, To Err is Human and Crossing the QualityChasm, consider these issues in discussing theprevention of medical errors and the improve-ment of clinical standards of care. In general,regulators and payers express a decreasing tol-erance for wide variations in care and out-comes, and an increasing interest in individu-alized, yet evidence-based, healthcare. Inaddition, health professionals and facilities willcontinue to be challenged by patients who de-mand greater participation in health decisionsand more accountability for consistent out-comes from healthcare service providers.

The use of sensor technologies in blood glu-cose monitoring and smart insulin delivery willmeet these growing demands for individual-ized, evidence-based care. Continuous glucosemonitoring by noninvasive or implantable sen-sor devices provides important information notcaptured by the current methods of glucosereadings. By facilitating tight glycemic controlfor both type 1 and type 2 individuals, this newdata stream should improve the quality of careand outcomes for many diabetics. Trend analy-ses of glucose levels by physicians and patientswill provide a more complete picture of eachpatient’s condition, supporting effective indi-vidualization of diabetes management regi-ments. With the coupling of smart sensors andinsulin delivery devices, automatic adjustmentof doses will reduce the need for active patientor physician intervention. This will decrease

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the possibility of error in drug administrationand further promote the personalization of careservices.

IMPACT ON HEALTHCARE DELIVERY SYSTEMS

Unlike some classes of emerging technologies,sensor technologies used in glucose monitoringand smart insulin delivery for diabetes care isunlikely to significantly change the settings inwhich care is provided. There will be reductionsin overall utilization of ambulatory and acutecare services, however. Admission rates for acuteand chronic complications of diabetes are ex-pected to fall, together with emergency depart-ment visits and average length of stay for suchadmissions. HealthTech’s expert panel offeredestimates of the range of magnitude for each ofthese forms of care, and further disucssed the im-pact on physician office visits as new technolo-gies are introduced. For example, implanted de-vices for glucose monitoring or drug deliverymay require more follow-up care than noninva-sive devices. In addition, sensor-based monitor-ing devices may require the examination of databy a clinician to ascertain the effectiveness of dis-ease management and to make appropriate mod-ifications. Monitoring the operation of these de-vices will also be a critical component of patientcare, because of the high degree of reliance uponthem, creating another new demand on cliniciancare teams. While physicians will direct the care,nurses and technicians are likely to do the ma-jority of the monitoring and tracking of the con-tinuous stream of patient data, according to theexpert panel.

While the expert panel expected sensor-based continuous glucose monitoring to beavailable in five years, they expressed concernabout physician resistance to this technology.As with other emerging technologies, physi-cian resistance—based on the status quo modelof care, skepticism about the quality and safetyof the technology, the potential lack of reim-bursement for the technology and physicianservices to support patient use of the technol-ogy, and the eventual decline in physician of-fice visits—will impede the uptake of the newtechnology by several years. Physician opposi-

tion to using emerging technologies that serveas intermediates between the patient and thephysician will limit patient access to new sen-sor-based monitoring devices. In addition,there will continue to be strong resistance totechnologies that keep the physician from di-rect care decisions in monitoring patients.Thus, the full impact of sensor-based devicesin diabetes care may be delayed for a few yearsbeyond market introduction of these products.

HEALTH INSURANCE COVERAGEIMPLICATIONS

As in the case of other beneficial medicaltechnologies, approval for coverage and pay-ment by health insurance companies will be apowerful determinant of the rate of adoptionfor these emerging sensor technologies. Insur-ers use highly variable criteria in decidingwhether to approve new technologies. Typi-cally, new devices must surmount two hurdles:(1) examination of evidence for the effective-ness of the technology and (2) comparativeevaluation of the new device against compet-ing new and older technologies for cost andquality. Future sensor-based glucose monitor-ing and insulin delivery devices seem likely toeventually satisfy the general criteria for tech-nology effectiveness. Further scrutiny of cost-effectiveness data may indicate that these sen-sor-based products result in incremental healthimprovements at significant cost for some dia-betic individuals. HealthTech’s expert panelsuggested that the segment of diabetic patientscapable of satisfactorily managing their condi-tion with current technologies may be excludedfrom health insurance coverage of new sensor-based devices. The experts agreed that brittlediabetics will be the first patient group to becovered, with the possibility of more clinicallystable patients following several years later.

DIRECT TO CONSUMER (DTC)MARKETING AND THE PATIENT

AS A CONSUMER

Product developers unable to demonstratesubstantial improvements in health outcomes

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and cost-effectiveness for nonbrittle diabeticsmay bypass the approval processes of govern-ment and private insurance policy bodies.These companies will release their products di-rectly to the consumer as lifestyle-enhancingtechnologies that may or may not requirephysician prescription. It is expected that DTCadvertising will have a very large impact on theadoption and diffusion of emerging sensor-based monitoring products for diabetes. As thepharmaceutical industry has demonstrated,DTC advertising is already a very powerfultool. Through media, marketing, and the In-ternet, patients will become increasingly awareof sensor-based devices, and may choose topurchase these products for their lifestyle ap-plications, not medical necessity. In this situa-tion, the patient acts as a consumer, choosingto pay for healthcare products and services thathave only marginal increases in clinical bene-fit. Generally, informed consumers who are ac-tive in managing their health may be earlyadopters of sensor-based diabetes technology,in addition to brittle diabetics with health in-surance coverage. These early adopters will an-ticipate greater convenience, mobility, and sim-plicity in use from sensor-based products,driving the rapid adoption and diffusion ofthese blood glucose monitoring and insulin de-livery devices.

As an emerging class of technology, sensor-based diabetes products will impact many ar-eas of healthcare. Several important policy and

regulatory factors will influence the adoptionand diffusion of sensor technologies in diabetesmanagement, including the impact on qualityand consistency of care, coverage and reim-bursement, and consumer demand and will-ingness to pay out-of-pocket for such medicaldevices. As the pace of adoption will bestrongly affected by these drivers and barriers,sensor technologies hold the promise of signif-icantly advancing diabetes management andsubstantially reducing the cost of clinical care.

ACKNOWLEDGMENTS

I wish to thank Molly Coye, M.D., and RobinCherry for their expert advice, review, and sup-port of this article.

REFERENCE

1. Armstrong JS: Long-Range Forecasting: From CrystalBall to Computer, 2nd ed. New York: Wiley, 1985.

Address reprint requests to:Meghna Chowdary, B.S.Health Technology Center

118 Second Street, Fifth FloorSan Francisco, CA 94105

E-mail: mchowdary@healthtechcenter.org

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