Digital data in diabetes, August 2016

August 12th, 2016 Azadi Parsian Hotel,
Tehran, IRAN
Translation of Digital to Clinical Practice
Seyed Adel Jahed, M.D.
Gabric Diabetes Education Association

August 12th, 2016
Azadi Parsian Hotel, Tehran, IRAN
Introduction
• As the number of people with diabetes rises, and with an inadequate number of specialists and
lack of resources in developing countries, there is an opportunity and growing need to develop
cost-effective supporting tools for DSME to improve overall diabetes outcomes.
• The wireless broadband and smartphone market reached 1.5 billion globally in 2013, expected
to rise to 6.5 billion by 2018.1
– As of September 2012, 51% of the 234 million Americans using a mobile device owned a smartphone.2
• With increasing numbers of smartphone users, it is possible to apply mobile app technology to
empower patients to better manage their diabetes.
1. Ericsson. http://www.ericsson.com/res/docs/2012/ericsson-mobility-report-november-2012.pdf. Accessed January 20, 2013.
2. Marketing Charts Staff. http://www.marketingcharts.com/wp/interactive/ smart phone-penetration-crosses-majority-threshold-of-mobile-market-24540/.
Accessed January 20, 2013.

August 12th, 2016
Classification of diabetes management systems according to whether or
not they are wireless or mobile
Klonoff DC, et al. J Diabetes Sci Technol 2013;7(3):749-58.

August 12th, 2016
What is mHealth?
• Mobile health (mHealth) is a term for using mobile communications devices for health
services and information.
– mobile phones, tablets, patient monitoring devices, PDA, or other wireless devices
Purposes of mHealth
• To provide enhanced access to health information to patients, HCPs, and researchers
• To facilitate remote monitoring and diagnosing of patients
• To deliver timely recommendations for health care
Klonoff DC, et al. J Diabetes Sci Technol 2013;7(3):749-58.

August 12th, 2016
The journey of digital data in diabetes
Measurement & documentation
• simply to perform SMBG
• to transfer SMBGs to a log book
• CGMS, simple or with hypo-alarm
• to share the patient BGs with the physician
Education
• to educate on diet & physical activity
• carbohydrate counting
• social support
Treatment facilitation
• notifications
• insulin dose adjustment
• pump treatment, open and closed loop

August 12th, 2016
Self-monitoring of blood glucose
Barriers in poor adherence to SMBG include
• inaccurate meters
• big and bulkier device
• need to poke a finger multiple times
• need to carry an additional device all the time
• paper log book entry
With the advances in blood glucose meters and mobile technology, it has become
possible to address several of these issues.
iBGStar is an external device that fits easily to an iPhone and functions as a glucose
meter that helps patients carry their glucose meter along with a smartphone.
• Studies have shown that iBGstar use is associated with higher patient satisfaction
and better glycemic outcomes in adults with T1DM.1
iBGStar’s blood glucose tracking trend chart
1. ShahV HW, et al. The Remote-T1d Study. Diabetes Technol Ther. 2015;17:A25–6.

August 12th, 2016
Glucometers, CGMS, BG charts
• Most manufacturers have designed clinical decision supporting websites to download blood glucose meter to
analyze the glycemic pattern and trends to help patients and clinicians with treatment decision.
• Most glucose meter manufacturers are now planning to integrate insulin calculators with traditional blood
glucose meters to help patients on multiple daily injections take their bolus insulin dose.
• The Dexcom G5 Mobile CGM System (the first and only fully mobile CGM system approved by the FDA for both
adults and children > 2 yrs) provides a simplified mobile interface with color dials and directional
arrows that allow for easy viewing, identification and assessment of glucose status.
– It integrates with the Health App on iPhone, allowing users to share glucose data with other apps and,
with user permission, enabling data to flow seamlessly from the G5 app into EHR software.
• The InPen connects to smartphones via bluetooth and send data back, including insulin dosage
and timing.
 The app allows patients to track and calculate doses, and set alarms for future doses.
http://www.meddeviceonline.com/doc/dexcom-g-cgm-now-available-on-apple-watch-0001. Accessed Aug 7, 2016.
http://legacymedsearch.com/companion-medical-wins-fda-510k-approval-for-wireless-enabled-inpen-insulin-pen-mobile-app/. Accessed Aug 7, 2016.

August 12th, 2016
Diabetes self-management
• Management of diabetes is generally self-directed, and individuals need to make day-to-day
decisions related to controlling their disease.
• Effective management requires patients to understand and use appropriate technologies for
glucose monitoring and medication compliance as well as complex treatment strategies.
• DSME is recognized as a crucial component in diabetes care and in limited pilot studies.1
– It has been shown to be cost-effective and efficacious in lowering A1c and blood pressure.2
1. Brunisholz KD, et al. J Multidiscip Healthc. 2014;7:533–42.
2. Tshiananga JK, et al. Diabetes Educ. 2012;38:108–23.

August 12th, 2016
Diabetes self-management goes digital
• The conventional education for diabetes self-management
has been supplemented with several web portals, blogs, and
structured online educational materials.
• The online portals and apps may be cost-effective,
convenient, easy to use and learn anywhere at anytime to
understand diabetes, its complications, and how to
individualize and self-manage.
Shah et al. Managing diabetes in the digital age. Clinical Diabetes and Endocrinology. 2015; 1:16

August 12th, 2016
Medication adherence
• Medication non-adherence remains a common health problem resulting in about 50 % of
medication related hospitalization and accounts for about $100 billion in health care cost.
• The advantages of using the adherence apps are simple to use and navigate, data storage,
medication instruction, and features to download and print a medication chart.
Osterberg L, Blaschke T. N Engl J Med. 2005;353:487–97.

August 12th, 2016
Insulin dose calculators
• Accurate bolus insulin doses require calculations based on factors such as current and target
blood glucose, carbohydrate-to-insulin ratios, total grams of carbohydrate in meals, insulin
sensitivity factors, and insulin on board.
1. Gross TM, et al. Diabetes Technol Ther. 2003;5:365–9.
2. Schmidt S, et al. J Diabetes Sci Technol. 2014;8:1035–41.
3. Rossi MC, et al. Diabetes Technol Ther. 2013;15:670–9.
• Introduction of automatic bolus calculators integrated in the insulin pump
(bolus wizard) have shown to help patients to more accurately meet prandial
insulin dosage requirements, improve postprandial glycemic excursions, and
achieve optimal glycemic control.1-3
– The majority of people with diabetes do not use insulin pumps due to cost, lack
of insurance coverage, or other unrelated issues.
– Apps such as Insulin Calculator, Bolus Calc, Insulin Dose Calculator Pro, and
Diabetes Personal Calculator for non-pump users are available to help patients in
insulin dosing.

August 12th, 2016
An Iranian tool for diabetes education & self-management
• Four applications supported by
a comprehensive diabetes site:
o Food Meter
o Easy Syringe
o Easy Insulin
o Easy Diabetes
www.hafezsalamat.ir

August 12th, 2016
Outcomes with the use of digital tools for diabetes self-management
• The use of digital health tools has increased. Almost one third of U.S. smartphone owners were
using health apps in 2014, and half of them were using fitness-related apps.
• Still data is lacking on its benefits and cost-effectiveness. Small studies have shown better
glucose control, improved SMBG frequencies, better patient satisfaction, moderate weight loss,
and medication adherence with the use of digital tools.
• Most of these studies are underpowered and of short duration.
– lacked a sufficient sample size or intervention
– length to determine whether the results are clinically meaningful
– high variability between studies and methodological weaknesses

August 12th, 2016
Number of diabetes mHealth articles by year of publication (n=212)
Garabedian, et al. Mobile phone and smartphone technologies for diabetes care and self-management. Curr Diab Rep (2015) 15:109

August 12th, 2016
Number of diabetes mHealth articles by type of article (n=212)
• Robust studies utilized one of the
following study designs:
o RCTs
o controlled before-after (CBA) studies
o interrupted time series (ITS) studies
with at least 3 time points before
and after the intervention
Garabedian, et al. Mobile phone and smartphone technologies for diabetes care and self-management. Curr Diab Rep (2015) 15:109

August 12th, 2016
Mobile applications for diabetics: a systematic review and expert-based usability
evaluation considering the special requirements of diabetes patients age 50 years or older
Aim: To examine all currently available diabetes apps for
Android and iOS (iPhone) operating systems to look at
functions, target user groups, accessibility, and ratings vs.
costs
Methods: All available diabetes apps in the Google Play Store
and Apple App Store were found by keyword and category
search.
• an expert-based usability evaluation was conducted with
three experts to determine whether applications serve the
needs of patients aged ≥ 50.
Results: 656 apps: 276 exclusively on iOS, 266 exclusively on
Android, and 114 available for both
Arnhold M, et al. J Med Internet Res 2014; 16: e104
• 54% offered just one function and 53% provided a
documentation function for users to document and track
blood sugar levels.
• 96% of users were patients.
• 54% were free apps; median price of paid apps was €1.90.
• Users rated the apps 3.6/5 stars, no significant differences
between free and paid apps.
• < 5% of the apps had an interface to measurement devices.
• 73% of apps offered the ability to read the screen content
aloud.
• The number of functions was significantly negative
correlated with usability.
Conclusions: while many apps for diabetes exist, most offer
similar functions and only offer a few functions in each app.

August 12th, 2016
Range of functions of diabetes apps available as of April 2013
Arnhold M, et al. J Med Internet Res 2014; 16: e104

August 12th, 2016
Are patients with diabetes mellitus satisfied with technologies used to assist with
diabetes management and coping?: a structured review
Aim
• To examine patient perceptions and satisfaction
regarding technologies such as SMS reminder
systems, online educational programs, and
electronic patient-physician communication
Methods
• Four databases (Embase, Psychinfo, Medline, CINAHL)
were searched.
Results
• 26 studies: 8 on T1DM, 9 on T2DM, and 9 on both.
• Studies reported high satisfaction from patients
regarding most devices, with little to no difference
based on intervention type or outcome measured.
Harrison S, et al. Diabetes Technology & Therapeutics 2014; 16: 771–83
• Satisfaction appeared to strongly correlate to ease
of use and improved management.
• Technical difficulties were barriers to both use and
satisfaction (web devices being the easiest to use and
devices such as smartphones being slightly more difficult).
• Devices that encouraged or facilitated interaction
between patients and either HCPs or peers were
valued and produced higher patient satisfaction
for increasing support.
Comment
• People are not looking for stand-alone
interventions but prefer those that are sponsored
by and integrated into therapeutic relationships.

August 12th, 2016
Physical activity
• Key components of weight loss management are self-monitoring of physical activity by means of recording
frequency, intensity, time, type of activity, and a healthy diet.
The use of videogames, gamification, and virtual environments in the self-management of diabetes:
a systematic review of evidence1
Aim: To examine behavioral, knowledge-based, biological, and psychological outcomes of studies on the
use of games in patients with diabetes.
Methods: PubMed, Web of Science, Scopus, and PsychINFO were searched for relevant articles
published in 2000-2014.
Results: 10/307 initially identified articles met the inclusion criteria.
 5 quantitative, 1 qualitative, 4 mixed, Only 1 was a RCT.
 Small sample sizes, short durations, heterogenous in intervention type
Conclusions: The use of games seems to be beneficial in aiding the management of diabetes, though
there is a relative lack of studies on the subject.
1. Theng Y-L , et al. Games Health J 2015; 4: 352–61 [Epub ahead of print]; 10.1089/g4h.2014.0114

August 12th, 2016
eHealth interventions for the prevention and treatment of overweight and obesity in adults:
a systematic review with meta-analysis1
Aim: to study the efficacy of eHealth interventions in the prevention & treatment of obesity and weight gain in adults
Methods: English-language studies from 1995 to September 2014 from eight databases were reviewed.
Results: 84 studies with 183 intervention arms:
 61 studies had the primary aim of weight loss, 10 weight loss maintenance, 8 weight gain prevention, and 5
weight loss and maintenance.
 eHealth interventions were predominantly delivered using the Internet, but also email, text messages,
monitoring devices, mobile applications, computer programs, podcasts and PDAs.
 45% of interventions used > 1 type of technology, and 43% were delivered solely using eHealth technologies.
 Meta-analyses demonstrated signiﬁcantly greater weight loss (kg) in eHealth weight loss interventions vs.
control (MD −2.70 [−3.33,−2.08], P < 0.001).
Conclusions: eHealth weight loss interventions demonstrated statistically significant, though modest, weight loss
compared with no or minimal treatment. There is still insufficient evidence to determine whether eHealth weight
loss maintenance or weight gain prevention interventions are effective.
1. Hutchesson MJ , et al. Obesity Reviews 2015; 16: 376–92

August 12th, 2016
Internet delivered diabetes self-management education: a review1
Aim
• To review various delivery methods of Internet diabetes
education, and their effectiveness in improving diabetes-
related outcomes
Materials and Methods
• Six databases were searched: CINAHL, PubMed, Medline,
EBSCO, the Cochrane Library, and the Web of Science
• English language articles published in the last 10 years
• 14/111 articles met inclusion criteria.
• Nine studies were RCTs.
• A total of 2,802 participants
• Study lengths from 2 weeks to 24 months
1. Pereira K, et al. Diabetes Technol Ther 2015; 17: 55–63
Results
• DSME delivered via the Internet was more effective at
improving measures of glycemic control and diabetes
knowledge compared with usual care.
• Improved eating habits and increased attendance at clinic
appointments occur after the online DSME, but usage of
Internet materials waned over time.
• Interventions that included an element of interaction with
HCPs were seen as attractive to participants.
Conclusions
• Internet-delivered diabetes education has the added benefit
of easier access for many individuals, and patients can self-
pace themselves through materials. More research on the
cost-benefits of Internet diabetes education and best
methods to maintain patient engagement are needed.

August 12th, 2016
Technology and diabetes self-management: an integrative review1
Aim
• An integrative review to evaluate different types of
technology used to facilitate diabetes self-
management and the effects of technologies on
diabetes outcomes
Methods
• Three databases (Medline, PubMed, and PsychINFO)
were searched.
• Articles from 2008–2013 were included.
• The articles relied on secondary data (editorials,
systematic reviews) or only described study protocol
were excluded.
1. Hunt CW. World J Diabetes 2015; 6: 225–33
Results
• 14 studies including qualitative, quasi-experimental,
and RCTs
• Data on outcomes such as HbA1c levels, self-
management behaviors, and diabetes self-efficacy
were extracted and compared.
Conclusions
• Technology-enabled interventions had mainly positive
impacts, but some interventions only had short-term
or no improvements in HbA1C levels, diabetes self
management behaviors, and diabetes self-efficacy.
• Technological interventions can benefit people with
T2DM when used in conjunction with diabetes care
delivered by HCPs.

August 12th, 2016
Barriers to use digital tools for diabetes management
1. Cost (smartphone, internet, insurances)
2. Accessibility (proper infra-structure, rural areas)
3. Insufficient scientific evidences (safety, efficacy, cost-effectiveness)
• source information available on the blogs or through social media that are not
regulated may not be scientific and may mislead patients.
4. Not useful in certain populations
• elderly, non-English speakers, physically challenged, and lower income
5. Data overload and time shortage for physicians
6. Data protection (server, ownership)
7. Data security (bluetooth, electromagnetic devices, cyber hackers)
8. Regulatory barriers

August 12th, 2016
Regulatory barriers
• The FDA considers any computer- or software-based devices (including apps) intended to be used for the
electronic transfer, storage, display, and/or format conversion of medical device data as a Medical Device
Data Systems (MDDS).
• The MDDS are classified in three different classes [Class III being high-risk to Class I being low-risk] based
on the potential risks of using the software or a digital tool.
• It has been recommended for the software or device developer to follow the regulatory requirements
such as Establishment registration, Medical Device listing, Quality System (QS) regulation, Labeling
requirements, Medical Device Reporting, and Reporting Corrections and Removals depending on the
device or software risk.
• Similarly, the European Union has also issued regulatory framework for the mHealh.
U.S FDA. Draft guidance for industry and FDA staff, mobile medical applications.
Available from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf. Accessed May 5, 2015
European Commission. Green paper on mobile Health (mHealth).
Available from http://ec.europa.eu/information_society/newsroom/cf/dae/document.cfm?doc_id=5147. Accessed on May 5, 2015.

August 12th, 2016
Future of digital health for diabetes-1
• The digital health industry is growing at a fast pace.
 globally $60 billion investment in 2013, expected to reach $233 billion by 2020
• Less barriers by U.S. government for digital innovations
• Integration of all EHR systems using a common platform
• Mobile software capable of calculating nutritional information based on their food intake
• Apps to remotely monitor a patient’s health (iExaminer)
• More videogames to change health behaviors

August 12th, 2016
Future of digital health for diabetes-2
• More patients will use insulin pump and CGM (sensor augmented therapy) with better glucose
control, less hypoglycemia, and reduce glucose excursion.
• Medtronic and Animas insulin pumps have integrated CGM data on insulin pumps. Still patients
have to wear CGM and insulin pumps separately.
o The research is under way to:
 prolong life of CGMs
 replace finger stick blood glucose monitoring to non invasive ways
 integrate CGM with an infusion set (Pod Talk and Medtronic in-Duo)
Closed-loop artificial pancreas development is rapidly going to integrate
algorithms in apps and come to real life.
Shah VN, et al. Diabetes Technol Ther. 2014;16:477–90.

August 12th, 2016
Conclusion
• There is much enthusiasm amongst industry and patients to use
digital tools for diabetes self-management.
• Large RCTs are needed to establish the effectiveness and cost-
benefits of digital tools in improving diabetes related outcomes.
• Despite many challenges to overcome, the future of the digital health
industry is promising.

Digital data in diabetes, August 2016

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