EVIDENCE-BASED DIGITAL HEALTH

Michael Bergen

02/22/2019

DISCLOSURE

• ( I have no disclosures )

PURPOSE

• Identify "clinically valid” digital health devices that can be

recommended/purchased by Duke Health for patients as it rolls out digital health

platforms

AIMS

• To evaluate the state of evidence-based literature describing the use of

digital health devices

• To identify problems and limitations of the current state of evidence-

based literature describing these devices

• To, hopefully, identify one or several devices that meet minimum

requirements to be safely recommended to Duke's patient population in

the following categories:

METRIC DEVICE

Glucometer

Sphygmomanometer

Watch

Scale

ECG

Thermometer

Glucose

Blood Pressure

Fitness, Heart Rate

Weight

Heart rhythm

Temperature

FDA MEDICAL DEVICE REGULATION 1

• The Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act

(FDC Act)

• Class I (47%) – These devices present minimal potential for harm to the user (enema kits and elastic

bandages). 47% of medical devices fall under this category

• 95% of these are exempt from the regulatory process.

• Class II (43%) – higher risk than Class I; must undergo special controls (powered wheelchairs, some

pregnancy test kits).

• Must submit a 501(k) demonstrating “substantial equivalence” to a predicate device

• Class III (10%) – usually sustain or support life, are implanted, or present potential unreasonable risk of

illness or injury (implantable pacemakers, breast implants)

• Must submit a Premarket Approval (PMA) - valid scientific evidence collected from human clinical

trials showing the device is safe and effective for its intended use

GLUCOSE

• Why?

• 2019 American Diabetes Association recommendations2

• “Most patients using intensive insulin regimens … should assess glucose levels using self-monitoring of

blood glucose (or continuous glucose monitoring) …”

• “self-monitoring of blood glucose may help to guide treatment decisions and/or self-management for

patients taking less frequent insulin injections”

• “ensure that patients receive ongoing instruction and regular evaluation of technique, results, and their

ability to use data from self-monitoring of blood glucose to adjust therapy. Similarly, continuous glucose

monitoring use requires robust and ongoing diabetes education, training, and support”

• Evidence:

• IDD: evidence clearly supports SMBG (lower A1C, rates of daytime/nocturnal hypoglycemia)3

• NIDD: “A key consideration is that performing SMBG alone does not lower blood glucose levels. To be useful, the

information must be integrated into clinical and self-management plans."

• “Nearly 1 in 6 non-insulin-treated patients practiced SMBG without either the patient or physician using the

results”4

GLUCOSE

• Glucose Meter Accuracy2

• International Organization for Standardization (ISO 15197:2013)

• FDA standard (Class II)

• "In the U.S., currently marketed monitors must meet the standard under which they were approved, which may not be the

current standard.”2

• "Moreover, the monitoring of current accuracy is left to the manufacturer and not routinely checked by an independent source.”2

Association AD. Diabetes Technology: Standards of Medical Care in Diabetes—2019. Diabetes Care. 2019;42(Supplement 1):S71-S80.

GLUCOSE

• The Diabetes Technology Society Blood Glucose Monitoring System Surveillance Program5

• 18 BGM’s representing 90% of products obtained by consumers from 2013-2015

• (only 6 of the top 18 glucose meters met the accuracy standard)

Klonoff DC, Parkes JL, Kovatchev BP,

et al. Investigation of the Accuracy of

18 Marketed Blood Glucose Monitors.

Diabetes Care. 2018;41(8):1681-1688.

GLUCOSE

• Comparative Accuracy of 17 Point-of-Care Glucose Meters6

GLUCOSE

Ekhlaspour L, Mondesir D, Lautsch N, et al. Comparative Accuracy of 17

Point-of-Care Glucose Meters. J Diabetes Sci Technol. 2017;11(3):558-566.

GLUCOSE

• Contour Next One

• MSRP: $19.99 – strips $0.83

• CONTOUR® DIABETES App compatible with iOS and Android

• 1) Data automatically exported from CONTOUR® DIABETES App to Apple Health via HealthKit integration

• Duke MyChart can periodically query Apple Health for updates

• 2) Data integrates into Glooko, which can be accessed by Epic or MyChart via public API

“Through REST-based APIs, Glooko

has integrated directly with… EPIC”

Glooko API

integrated

into Duke

MyChart app

CONTOUR® DIABETES App

GLUCOSE

• Accu-Chek Nano ($9.99 - strips $0.63)

• Accu-Chek Aviva (~$30 - strips $1.58)

iOS

Android

Glooko API integrated

into Duke MyChart app

GLUCOSE

• Overall

• Assortment of peer-reviewed literature on glucometer accuracy, but no standardized,

independent analysis

• Price is difficult to determine (especially for the test strips) due to variation in

insurance coverage

• Consumers likely turn to consumer reporting sites for help, which are fraught with

bias

BLOOD PRESSURE7

• Why?

• 103 million adults in the US with HTN; ~$131 Billion in costs each year

• Self-measured blood pressure (SMBP) is indicated for HTN, DM, ESRD, and others

• “Masked HTN”: ~ 30% in-office false negative rate

• “White coat HTN”: ~ 35% in-office false positive rate

• SMBP plus usual clinical care > usual clinical care alone7

• SMBP more predictive of all-cause and cardiac mortality than clinic BP

• ”Masked” HTN associated with greater risk of death than sustained HTN

BLOOD PRESSURE

• Cuff validation

• FDA class II

• Validation protocols:

• Improving the accuracy of blood pressure measurement: the influence of the European Society of Hypertension International Protocol (ESH-

IP) for the validation of blood pressure measuring devices and future perspectives (Stergiou et al.)8

• 323 home BP monitors, 12 validated in children, 25 validated in pregnancy

• American Pharmacists Association, American Medical Association (AMA), Association for the Advancement of Medical

Instrumentation (AAMI), American Heart Association (AHA), American Society of Hypertension (ASH), and Canadian

Hypertension Education Program (CHEP)

• Coalition for Accurate Measurement of Blood Pressure (CAMBP) with the intent to develop a publicly available Validated Blood

Pressure Device Listing (VDL) by Nov 2017

• So where is it?

BLOOD PRESSURE

• Target: BP (AMA + AHA)

• Minimum recommended requirements

• Automatic inflation functionality.

• Upper arm cuff (unless the patient’s arm circumference is too large—in which case, use of a wrist device with proper technique is acceptable).

• Large screen for patients with poor eyesight.

• Optional Bluetooth connectivity to allow patients to synchronize with other devices.

• Date and time stamp for review of readings.

• Memory to store at least 30 BP readings.

• Ability to average 2 to 3 blood pressure readings taken over 10 minutes or less if possible.

• Clinically validated device tested for accuracy

• Proper cuff sizing

• Public protocol and data collection system for health systems to join

• https://targetbp.org

BLOOD PRESSURE

• Omron 10 Series (BP786, HEM-7321T-Z)• Validated under the European Society of Hypertension International Protocol9

• $69.99

LIMITATIONS & CHALLENGES

• Sharing devices is not always user-friendly

• Lag between new technology and clinical validation

• Major shortcomings of clinical validation protocol

REFERENCES

1. https://www.fda.gov/medicaldevices/resourcesforyou/consumers/ucm142523.htm

2. Association AD. Diabetes Technology: Standards of Medical Care in Diabetes—2019. Diabetes Care. 2019;42(Supplement 1):S71-S80.

3. Garber AJ. Treat-to-target trials: uses, interpretation and review of concepts. Diabetes Obes Metab. 2014;16(3):193-205

4. Grant RW, Huang ES, Wexler DJ, et al. Patients who self-monitor blood glucose and their unused testing results. Am J ManagCare. 2015;21(2):e119-129.

5. Klonoff DC, Parkes JL, Kovatchev BP, et al. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018;41(8):1681-1688.

6. Ekhlaspour L, Mondesir D, Lautsch N, et al. Comparative Accuracy of 17 Point-of-Care Glucose Meters. J Diabetes Sci Technol. 2017;11(3):558-566.

7. Banegas JR, Ruilope LM, de la Sierra A, et al. Relationship between Clinic and Ambulatory Blood-Pressure Measurements and Mortality. N Engl J Med. 2018;378(16):1509-1520

8. Stergiou GS, Asmar R, Myers M, et al. Improving the accuracy of blood pressure measurement: the influence of the European Society of Hypertension International Protocol (ESH-IP) for the validation of blood pressure measuring devices and future perspectives. J Hypertens. 2018;36(3):479-487.

9. Belghazi J, El Feghali RN, MoussalemT, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400