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Digital Medicine - 2018Year in
Review, 2019 Year in Preview
July 2018
John Sharp, PCHAlliance
Ashish Atreja, Mt. Sinai
Brian Van Winkle, Johns Hopkins
Results From a Trial of an Online Diabetes
Prevention Program Intervention
What
Non-randomized trial using comparative
analysis of online (n=268) versus in
person (n=273) participants in DPP.
Significance
The online group
completed more sessions;
online and in person
groups both lost 4+ kg,
and there was no
difference in weight
change. ”An intensive,
multifaceted online DPP
intervention may be as
effective as in-person
DPP and help expand
reach to those at risk.”
Long-term Outcomes of the Effects of Home Blood
Pressure Telemonitoring and Pharmacist Management
on Blood Pressure Among Adults With Uncontrolled
Hypertension
What
Follow-up of a cluster randomized trial of 326
patients with uncontrolled hypertension. home
blood pressure telemonitoring with pharmacist
management lowered blood pressure more than
usual care in the first 18 months, but this was
not sustained through 54 months
Significance
Long-term maintenance
strategies may be needed
to sustain blood pressure
intervention effects over
several years.
Source: JAMA
Rationale and design of a large-scale, app-
based study to identify cardiac arrhythmias
using a smartwatch: The Apple Heart Study
What
Prospective, single arm pragmatic study
that has enrolled 419,093 participants
objective is to measure the proportion of
participants with an irregular pulse
detected by the Apple Watch
.
Significance
provide initial evidence for
the ability of a smartwatch
algorithm to identify pulse
irregularity and variability
which may reflect
previously unknown AF
First large scale study to
use a wearable for
diagnostic purposes
Government Support for Digital Health and Evidence
What
• Startup Days around the country to support
startups through multiple HHS agencies
• FDA – Pre-Certification Program
• CMS – new CPT codes on remote patient
monitoring
• 21st Century Cures Act supporting telehealth
and remote monitoring
• AHRQ – Set Up App Challenge – patient self
assessments
Significance
Support for innovation,
telehealth and reducing
regulatory barriers
12 healthcare algorithms cleared by the FDA
What
• Clinical Decision Support – CT results
for stroke
• Prioritize adults patients likely presenting
with acute intracranial hemorrhage
• Diabetes treatment decision support
product that analyzes data from
continuous glucose monitors, insulin
pumps and self-monitoring to determine
an insulin delivery recommendation
• Atrial Fib algorithm
• Coronary Calcium Scoring algorithm
Significance
As AI cements its role in
healthcare, more and
more intelligent software
offerings are pursuing
510(k) and De Novo
approvals
Source: The Lancet
Building A Regulatory And Payment
Framework Flexible Enough To Withstand
Technological Progress
What
In the face of rapid innovation, it has
been difficult to fit these products and
services into existing regulations of the
Food and Drug Administration and the
Centers for Medicare and Medicaid
Services, particularly when these
frameworks never contemplated what
communications technologies can do
today..
Significance
Both the FDA and CMS
can learn what not to do
from their past and what to
do going forward from
each other. Both have at
their disposal powerful
levers to interpret arcane
statutes and help spur
innovation
Health Affairs
Closed-loop insulin delivery in suboptimally
controlled type 1 diabetes: a multicentre, 12-
week randomised trial
What
Randomized Clinical Trial of 86 patients
randomized to closed-loop therapy and
sensor augmented pump therapy
Source: The Lancet
.
Significance
Hybrid closed-loop insulin
delivery improves glucose
control while reducing the
risk of hypoglycaemia
across a wide age range
in patients with
suboptimally controlled
type 1 diabetes.
New Digital Biomarkers
What
Quantifying beta-agonist utilization:
Occasions or puffs?
Significance
Digital inhaler for asthma
can measure frequency
and number of doses
which can inform
treatment both for the
physician and patient
The Journal of Allergy and Clinical Immunology
Harnessing the Consumer Movement
What
American College of Physicians develops
a position paper on Principles for Patient
and Family Partnership in Care
Significance
The ACP acknowledges
not only patient-centered
care but partnership in
care.
Implications for
patient/consumer-facing
apps and devices.
AMA Digital Health Playbook
What
Practical guide leading from identifying
the need and forming a team to
contracting
To partnering and evaluating the
success.
12 steps
Significance
Largest physician
organization devoting
significant resources to
digital health transforming
the practice of medicine.
Digital Therapeutics Alliance
What
Members from a variety of startups
Published a definition of digital
therapeutics.
dtxalliance.org
Significance
This new field is defining
itself, sharing approaches
and creating significant
partnerships.
Virtual Reality
What
First Virtual Medicine Conference
Brennen Spiegel, MD of Cedars Sinai
Significance
Field is maturing
Multiple use cases
Building an evidence base
What to Expect in 2019?
• Multi-site clinical trials
• More evidence for new technologies
• Chatbots for patient engagement validated
• Expanded support for innovation from
government agencies
• Better measurement of patient reported
outcomes (PROs) via digital
• New models of clinical trial design for digital
health interventions
• Broader collaborations between nodes and
health systems

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Digital medicine - year in review 2018 and forward look to 2019

  • 1. Digital Medicine - 2018Year in Review, 2019 Year in Preview July 2018 John Sharp, PCHAlliance Ashish Atreja, Mt. Sinai Brian Van Winkle, Johns Hopkins
  • 2. Results From a Trial of an Online Diabetes Prevention Program Intervention What Non-randomized trial using comparative analysis of online (n=268) versus in person (n=273) participants in DPP. Significance The online group completed more sessions; online and in person groups both lost 4+ kg, and there was no difference in weight change. ”An intensive, multifaceted online DPP intervention may be as effective as in-person DPP and help expand reach to those at risk.”
  • 3. Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension What Follow-up of a cluster randomized trial of 326 patients with uncontrolled hypertension. home blood pressure telemonitoring with pharmacist management lowered blood pressure more than usual care in the first 18 months, but this was not sustained through 54 months Significance Long-term maintenance strategies may be needed to sustain blood pressure intervention effects over several years. Source: JAMA
  • 4. Rationale and design of a large-scale, app- based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study What Prospective, single arm pragmatic study that has enrolled 419,093 participants objective is to measure the proportion of participants with an irregular pulse detected by the Apple Watch . Significance provide initial evidence for the ability of a smartwatch algorithm to identify pulse irregularity and variability which may reflect previously unknown AF First large scale study to use a wearable for diagnostic purposes
  • 5. Government Support for Digital Health and Evidence What • Startup Days around the country to support startups through multiple HHS agencies • FDA – Pre-Certification Program • CMS – new CPT codes on remote patient monitoring • 21st Century Cures Act supporting telehealth and remote monitoring • AHRQ – Set Up App Challenge – patient self assessments Significance Support for innovation, telehealth and reducing regulatory barriers
  • 6. 12 healthcare algorithms cleared by the FDA What • Clinical Decision Support – CT results for stroke • Prioritize adults patients likely presenting with acute intracranial hemorrhage • Diabetes treatment decision support product that analyzes data from continuous glucose monitors, insulin pumps and self-monitoring to determine an insulin delivery recommendation • Atrial Fib algorithm • Coronary Calcium Scoring algorithm Significance As AI cements its role in healthcare, more and more intelligent software offerings are pursuing 510(k) and De Novo approvals Source: The Lancet
  • 7. Building A Regulatory And Payment Framework Flexible Enough To Withstand Technological Progress What In the face of rapid innovation, it has been difficult to fit these products and services into existing regulations of the Food and Drug Administration and the Centers for Medicare and Medicaid Services, particularly when these frameworks never contemplated what communications technologies can do today.. Significance Both the FDA and CMS can learn what not to do from their past and what to do going forward from each other. Both have at their disposal powerful levers to interpret arcane statutes and help spur innovation Health Affairs
  • 8. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12- week randomised trial What Randomized Clinical Trial of 86 patients randomized to closed-loop therapy and sensor augmented pump therapy Source: The Lancet . Significance Hybrid closed-loop insulin delivery improves glucose control while reducing the risk of hypoglycaemia across a wide age range in patients with suboptimally controlled type 1 diabetes.
  • 9. New Digital Biomarkers What Quantifying beta-agonist utilization: Occasions or puffs? Significance Digital inhaler for asthma can measure frequency and number of doses which can inform treatment both for the physician and patient The Journal of Allergy and Clinical Immunology
  • 10. Harnessing the Consumer Movement What American College of Physicians develops a position paper on Principles for Patient and Family Partnership in Care Significance The ACP acknowledges not only patient-centered care but partnership in care. Implications for patient/consumer-facing apps and devices.
  • 11. AMA Digital Health Playbook What Practical guide leading from identifying the need and forming a team to contracting To partnering and evaluating the success. 12 steps Significance Largest physician organization devoting significant resources to digital health transforming the practice of medicine.
  • 12. Digital Therapeutics Alliance What Members from a variety of startups Published a definition of digital therapeutics. dtxalliance.org Significance This new field is defining itself, sharing approaches and creating significant partnerships.
  • 13. Virtual Reality What First Virtual Medicine Conference Brennen Spiegel, MD of Cedars Sinai Significance Field is maturing Multiple use cases Building an evidence base
  • 14. What to Expect in 2019? • Multi-site clinical trials • More evidence for new technologies • Chatbots for patient engagement validated • Expanded support for innovation from government agencies • Better measurement of patient reported outcomes (PROs) via digital • New models of clinical trial design for digital health interventions • Broader collaborations between nodes and health systems