Telemedicine Medication/ Wearable Central Automation Monitoring - - PDF document
10/10/2018 Smart Technologies to Disclosures Enhance Diabetes Management and Communication None Robert J. Rushakoff, MD Professor of Medicine University of California, San Francisco robert.Rushakoff@ucsf.edu Telemedicine Medication/
Robert J. Rushakoff, MD Professor of Medicine University of California, San Francisco robert.Rushakoff@ucsf.edu
None "Each blind man perceived the elephant as something different: a rope, a wall, tree trunks, a fan, a snake, a spear..."
inpatient/outpatient
Personal/central
Journals
JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY DIABETES TECHNOLOGY & THERAPEUTICS
National/International DM technology
meetings
International Inpatient DM meetings
Romeo
a six-ounce, hand-held device that resembles a pocket calculator. Glucose Monitor Programmed to beep at set times as reminder when to test blood sugar, take insulin, eat meals and exercise 3 month storage Records blood sugar With push of button, records insulin doses, amount of food eaten, intensity of exercise done and the times at which all those activities took place
Juliet
device produces printouts Can send data to provider using a telephone modem.
Robert Ratner, MD: It's not perfect for everybody. It's a lot of work, a lot of effort, and a lot of patients are unwilling to do that. And, frankly, for a lot of patients, it's not necessary. Patient’s MD: Those who benefit most those whose diabetes is out of control and those who are newly diagnosed and need to become aware of how different things affect them. Most people can use the system, for several months and then "graduate" to using just a diary and a simple blood sugar monitor. Those who want to, can buy their own system - hospitals lend or rent them to patients - but the system is expensive and not always reimbursable by insurance. Romeo costs about $495; Juliet, $275.
metabolic control
the DIANET vs conventional treatment, and a significant reduction of hypoglycemic reaction in both group
Chemstrip bG When strip gone -
Chemstrip bG When strip gone - - device worthless Technology limited to single device
(expensive and was not covered by insurance)
Time consuming ? Who really needed it Who will pay
Make stuff easier to do
For the patient; For the MD/Nurse/Pharmacist
Integration Supports normal Workflow Scalable Sustainable Cost effective
Numbers, numbers and more
Potential to overwhelm patients,
clinicians or other care givers
? How to actually interpret all the
data and actually make real time use
Wrong time on meters Wrong time on pumps
While new technology is cool - -
Have to show some improved
Not short term studies
Generally - - still have to prick finger You get glucose value ? Remains on value for patients not on
insulin
Patients on insulin - - more is better
CGM devices continue
to improve, with interfaces that wirelessly transmit data to smartphones
example, the Dexcom G5 mobile CGM helps caregivers to monitor their family members with diabetes and also allows physicians to monitor several of their patients at once
Glucose Meters: Abbot Freestyle Libre/Flash
interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin and held in place with a small adhesive pad.
can be worn on the back of the upper arm for up to 14 days
sensor to get a glucose result painlessly in less than one second.
sensor is under clothing
Case 1: 54 yr old man with hx kidney transplant
The good…
The not-so-good…
consistent)
(for now - - phone in Europe)
Supplies, Byram Healthcare, Solara Medical Supplies, Edwards Health Care Services, Better Living Now, and Mini Pharmacy)
Next Gen CGMs
calibration per day, 8.8% with no calibrations INTERACT WITH SOME PUMPS
platform
*mean absolute relative deviation
Newer pumps more user friendly Some integration with CGM Touch screen, small BUT - - still just pumps and requires a user who really
knows how to interpret data, make changes, input correct information.
Medtronic Pumps/CGM
SmartGuard™
when the glucose levels are predicted to hit the low limit in the next 30 minutes
glucose levels hit the low limit.
infusion for a maximum of 2 hours when sensor glucose (SG) levels are predicted to approach a pre-determined threshold and, without intervention, will resume basal insulin delivery to its pre- set rate.
Tslim/ (Dexcom)CGM
>8 units of insulin/day
user
programed by user. Insulin suspended if CGM value falls below threshold.
programmed by user. Insulin suspended if CGM value predicted to fall below threshold.
system automatically adjusts basal insulin based on CGM values to target of 120 mg/dL (or 150 mg/dL during exercise). User must still manually deliver insulin during meals and ”announce” exercise. No automated correction boluses based on CGM. Suggests correction amounts based on fingerstick result (similar to current bolus wizard).
Sensor MARD Avg Guardian 3 - 10.55% Enlite - 14% Dexcom G5 - 9%
Median and Interquartile range of sensor glucose values midnight to midnight Gray and dotted line = Run In Pink and solid line = Study
Other Closed Loop Systems in Development
Tandem (t:slim x2) – Dexcom G6 (launched 2018 with
autosuspend) – (automode expected 2019)
Bigfoot Biomedical – meal announcement will not require
carb estimation
Beta Bionics (dual hormone – glucagon and insulin) Insulet – Dexcom G6 (expected launch 2020) International Diabetes Closed Loop Consortium Diabeloop
Diabetes Technology: 2017 Update 37
Greater peace of mind Improved sleep quality Reduced fear of hypoglycemia More time in range Waking up more mornings with on-target BG Less time at extreme high and low
Less diabetes hassle Decreased sense of regimen burden Increased freedom to participate in activities
correctional boluses
1.
The algorithm doesn’t really “learn” you. It adapts to past 6 days.
2.
The system is relatively conservative.
3.
You lose a lot of flexibility.
4.
It chooses sensitivity factors / correction automatically. You only change carb ratios.
5.
Sensors can be somewhat unreliable.
6.
Some patients may lose a sense of being in control.
It still takes a lot of work and patient input, but, most of the time you have to “let go”
Here is what 670G use looks like…
Simplified Artificial Pancreas System (APS)
medical devices, commodity hardware, and open source software
simplicity, and interoperability with existing treatment approaches as well as existing devices.
be both safer and more effective than current state-of-the-art standalone insulin pump therapy, and that this can be demonstrated far more easily than for the completely novel therapy approach employed by the full APS systems that have been in clinical trials for years and are still years away from FDA approval.
Arnhold M, et al. J Med Internet Res. 2014.
EndoGoddess: gone Bant: .99 too much 3 others gone 1 still there - -out of date info
Diabetek – (2016 – now gone) Diabetic Connect Diabetes Pilot Pro. Food database Diabetes Tracker BG Monitor Diabetes OnTrack Diabetes Diabetes in Check Glucosio
Smartphone apps for calculating insulin dose: a systematic assessment
46 calculators that performed simple mathematical
measured blood glucose.
59% (n = 27/46) of apps included a clinical disclaimer
30% (n = 14/46) documented the calculation formula.
91% (n = 42/46) lacked numeric input validation,
59% (n = 27/46) allowed calculation when one or more values were missing
48% (n = 22/46) used ambiguous terminology
9% (n = 4/46) did not use adequate numeric precision
4% (n = 2/46) did not store parameters faithfully. BMC Medicine 2015 13:106
Smartphone apps for calculating insulin dose: a systematic assessment
67% (n = 31/46) of apps carried a risk of inappropriate output dose recommendation that either violated basic clinical assumptions (48%, n = 22/46) or did not match a stated formula (14%, n = 3/21) or correctly update in response to changing user inputs (37%, n = 17/46).
Only one app, for iOS, was issue-free
No significant differences were observed in issue prevalence by payment model or platform.
majority of insulin dose calculator apps provide no protection against, and may actively contribute to, incorrect or inappropriate dose recommendations that put current users at risk of both catastrophic overdose and more subtle harms resulting from suboptimal glucose control.
BMC Medicine 2015 13:106
Every company has different platform
Patient shows up, you can quickly pull up one but spend 10 minutes figuring out how to do downloads
Multiple reports on platform and can take 10 more minutes to find best report
Would be nice to say -- everyone use this meter/pump/cgm but insurance companies (and patients) have other ideas
Devices and software with more sophisticated algorithms that can perform pattern recognition. The question is how well that type of advancement can work.
Glooko’s Product Line Glooko Suite of Solutions
Glooko MeterSync Device and Mobile App For personal use Improves self-management Glooko Kiosk for Offices For clinical use Improves office workflow MyGlooko Web App + Glooko Population Tracker For remote monitoring Enables on-demand care Glooko APIs EHR and other system integrations
nonprofit company based in San Francisco, is currently building three applications
Uploader: uploading data from insulin pumps, CGMs and blood glucose meters to the platform. Blip:
Nutshell: mobile app, helps patients with diabetes to better manage the meals they eat and to properly dose insulin for them.
Initial Download Permissions
82% full network access 64% modify USB storage 30% read phone status and identity 14% find accounts on phone 11% view wifi connections 4% modify users contacts 4% view call logs
Transmission Analysis
82% collected and shared data
(insulin/glucose) with 3rd party
82% placed cookies
Sharing of sensitive Health info by apps
not prohibited by HIPAA
Patients might mistakenly believe that
health information entered into an app is private (particularly if the app has a privacy policy), but that generally is not the case. Medical professionals should consider privacy implications prior to encouraging patients to use health apps.
Sanofi, Aetna-Inova JV target diabetes with digital therapeutic pilot program
September 25, 2017 Sanofi and Innovation Health — an insurance company jointly run by Inova and Aetna —have announced a pilot program examining the impact of digital health strategies to improve care for Type 2 diabetes patients. The program will tap One Drop, a diabetes self-management app and Bluetooth blood sugar monitor, and Gocap, a mobile- friendly device and insulin dose management platform that emphasizes physician involvement, in an effort to improve medication adherence and patient
Make stuff easier to do Improve glucose
control
Increase in glucoses in
range
Reduce hypoglycemia
Improve outcomes
Infections Mortality
Reduce errors
Orders Administration Documentation
Reduce Costs
Reduced length of
stay
Reduced rate of
readmission
all adult inpatients) :
– 2 or more glucoses>225 mg/dl – Glucose <60 mg/dl – On insulin pump – Dx type 1 DM
glucose management service.
APEX, we remotely entered recommendations for insulin changes in a glucose management note which could be seen by all clinicians.
Trend in hyperglycemia rate before and after introduction of the Virtual Glucose Management Service
(Number per 100 hospitalized patients with 2 or more POC glucose reading ≥ 225 mg/dL) Hyperglycemia rate decreased slightly (P = 0.11) throughout the 12 months prior to the introduction of vGMS and more steeply (P<0.001) during the 24 months afterwards.
Rushakoff et al. Ann Int Med May 2017
Trend in hyperglycemia rate before and after introduction of the Virtual Glucose Management Service
(Number per 100 hospitalized patients with 2 or more POC glucose reading ≥ 225 mg/dL)
2018OCT
The impact of the Virtual Glucose Management Service
Decrease in Hyperglycemia: – 39% decrease in number of patients on daily hyperglycemia morning list Decrease in Hypoglycemia: – 38% decrease in glucoses <70 mg/dl* – 64% decrease in glucoses <40 mg/dl* (only 15 total last year)
glucoses for more than 1 day
hyperglycemic
Rushakoff et al. Ann Int Med May 2017
Number of vGMS notes in past 4 years:
7000
Time to complete task:
First months: 45-90 minutes Now:
20-40 minutes
Change in number of Formal Endocrinology
Consults: no
Significant infrastructure in place Trained motivated staff Notes short, provided just in time
education
Staff did not want to receive a vGMS
note - - a sign of failure!
Disagree 1% Agree 38% Strongly Agree 61% Disagree 1% Neutral 22% Agree 63% Strongly Agree 14%
How often does implementation of these recommendations lead to improvement in your patient's glucose?
Never 1% Sometimes 11% Often 66% Always 22%
How often do you find the glucose management note recommendations to be helpful?
Never 1% Sometimes 8% Often 49% Always 42%
The vGMS is a useful educational tool for the management of diabetes. Past vGMS recommendations have changed the way you manage diabetes in your patients.
vGMS Resident Survey Results: 2017
Joshua A Rushakoff, Zachary Kornberg. Medical Education, in press
“I know that for my interns, the feedback really drives their own improvements because they want to avoid getting a “glucose note" in the chart the next morning. And it works as a perfect "just-in-time" teaching mechanism to inform appropriate responses to high blood sugars for inpatients.”
Physicians Can be Trained Physicians have knowledge Remain afraid to implement insulin
dosing; afraid of lows
Need permission to make changes and
be aggressive
Can be shamed! “Rushakoff’d”