THE IMPACT OF DIGITAL TECHNOLOGY IN THE COMMUNICATION

THE IMPACT OF DIGITAL TECHNOLOGY IN THE COMMUNICATION WITH PATIENTS Giuseppe Defeudis MD, Ph. D Italian Coordinator of Youngest of Italian Society of Diabetes (SID) Dept. Endocrinology & Diabetes University Campus Bio-Medico, Rome, Italy g. defeudis@unicampus. it Panel 2 - skills and training 1

DISCLOSURE STATEMENT Speakers Name: Giuseppe Defeudis �I have no conflicts of interest to report linked to this speech. G. Defeudis, Bruxelles 2019 2

G. Defeudis, Bruxelles 2019 3

Just few days before… Balint introduced the concept of ‘DOCTOR AS A DRUG’, according to which the quality of the relationship supplements the treatment. Thus, if the relationship is good, the prescribed drug or therapy is more effective. THE PHYSICIAN–PATIENT RELATIONSHIP WORKS BEST WHEN THE PATIENT RECEIVES MORE TIME, INFORMATION AND CARE FROM THE SPECIALIST. …right now THE DOCTOR–PATIENT RELATIONSHIP, which is traditionally based on paternalism and hierarchy, HAS BEEN SIGNIFICANTLY CHANGING mainly due to: 1) THE RISING NUMBER OF PATIENTS WITH CHRONIC CONDITIONS 2) THE DIGITAL ERA bmj 2019 Balint M. 2000. G. Defeudis, Bruxelles 2019 4

…right now NO MATTER WHAT MODEL WE USE, THE TRANSFORMATION OF THE NEW RELATIONSHIP HAS BEEN CATALYSED BY THE DIGITAL ERA. All these lead to fundamental changes in the relationship between patients and physicians. EQUAL LEVEL PHYSICIAN–PATIENT RELATIONSHIP WITH SHARED DECISION-MAKING AND THE DEMOCRATIZATION OF CARE. Mesko B, et al. BMJ Open 2019 G. Defeudis, Bruxelles 2019 5

E-patients use ordinary technologies All participants use digital health technologies that can be divided into two main categories: COMMUNICATION TOOLS (social media channels such as blogs and Twitter, websites, online forums, Open Notes, Skype and Whats. App) and DEVICES OR SENSORS such as Fitbit, insulin pumps, glucose sensors or self-made continuous glucose monitors Mesko B, et al. BMJ Open 2019 G. Defeudis, Bruxelles 2019 6

The evolving digital health regulatory environment (FDA) Current FDA guidance for digital health review includes the following categories: 1. Mobile Wellness Apps: No regulatory oversight is required for these health and wellness apps. The vast majority of apps are in this category. 2. Lower Risk Mobile Apps/Medical Devices: The FDA labels this category of apps as enforced discretion and includes a much smaller number of apps in the following subgroups: - Tools to organize and track health information (not for treating or adjusting medications); - Tools to access health information and communicate with health providers; - Tools that automate simple health care providers’ tasks. 3. Mobile Medical Apps Connected to a Class 2 Medical Device: The few apps in this category require FDA oversight because thet’re intended to be used as an accessory to already regulated medical devices or transform a mobile platform into a regulated device. http: //www. fda. gov/Medical. Devices/Digital. Health/Mobile. Medical. Applications/default. htm G. Defeudis, Bruxelles 2019 7

The digital clinic The concept of a “digital clinic” is evolving, with the digital clinic basically intended to REPLACE some or all of the FACE-TO-FACE CLINICAL ENCOUNTERS with VIRTUAL COMMUNICATION between the patient and the Healthcare team (HCT). The data are collected, analyzed, and presented to the HCT in an easy to read manner. The HCT reviews the data and formulates CLINICAL RECOMMENDATIONS alone or with the assistance of decision support algorithms. The clinical recommendations are conveyed to the patient via DIGITAL WAYS as email, SMS, through the dedicated app, or by telephone or video conference. THE HCT IS ABLE TO MONITOR THE PATIENT’S ADHERENCE TO THE TREATMENT RECOMMENDATIONS AND ASSESS THE CLINICAL OUTCOMES. G. Defeudis, Bruxelles 2019 8 Cahan A, …, Raz I, Journal of Diabetes, 2018

Tech on DIABETES requires regular follow-up and therapy progression… not only BENEFITS FOR PHYSICIANS and PATIENTS TECHNOLOGY The ANYTIME-ANYWHERE nature of digital technology supports the delivery of automated, individualized coaching, enabling patients to address their health issues by sharing data and connecting with their health care team when needed in between scheduled appointments. G. Defeudis, Bruxelles 2019 9

G. Defeudis, Bruxelles 2019 Connected devices for management and monitoring of diabetes 10 Fagherazzi G, Ravaud P. , Diabetes & Metabolism 2018

Evidence of the clinical benefits of clinical technology in the management of T 2 D Lifestyle modification is commonly performed in a face-to-face interaction, which can prove costly. Mobile phone apps provide a more accessible platform for lifestyle modification in diabetes. There is strong evidence for the efficacy of mobile phone apps for lifestyle modification in T 2 D. G. Defeudis, Bruxelles 2019 11 Wu X et al. , JMIR Mhealth Uhealth 2019

Decrease from baseline in glycated hemoglobin (Hb. A 1 c) after 12 and 24 weeks of home use in participants with T 1 D or T 2 D in the meter-only and meter + app groups Results about training… In participants with T 2 D, the reduction in Hb. A 1 c from baseline was more pronounced in the meter + app group than in the meter -only group, especially at 12 weeks (1. 04% vs 0. 58%), P=. 09 G. Defeudis, Bruxelles 2019 12 Grady M et al. , JMIR DIABETES 2017

Results about training… The use of the automated Web-based ANODE e -coaching program in patients with T 2 D and abdominal obesity was associated with a significant control-subtracted improvement in diet quality and several important cardiometabolic risk factors. The program can be delivered remotely with limited human resources, and therefore has potential for cost-effectiveness, and subsequently broad dissemination if generalizability and longer-term sustainability are demonstrated. G. Defeudis, Bruxelles 2019 13 Hansel B et al. , J Med Internet Res 2017

Digital therapy is a GOOD FIT for chronic care (required in T 2 D): MONEY By reducing the burden of chronic diseases such as diabetes, digital therapies can help create a rare win-win in health care. DAY-TO-DAY MANAGEMENT The anytime-anywhere nature of digital technology supports the delivery of automated, individualized coaching, enabling patients to address their health issues. DAILY BEHAVIOURS MATTER Software-based interventions provide a continuous feedback loop that is necessary when building the small daily habits that can have an outsized impact on health and quality of life. G. Defeudis, Bruxelles 2019 14

RISKS ON LINE MEDIA + E-VISITS PATIENT/DOCTOR RELATIONSHIP INCOMPLETE QUALITY OF VISIT MISUNDERSTANDINGS ABOUT THERAPY DOCTOR BURNOUT … G. Defeudis, Bruxelles 2019 15

7. 7 LEARNING, TRAINING AND SUPPORT The basic training and continuing professional development of healthcare professionals should equip them with the ability to operate effectively in the information-rich healthcare environment rather than just providing basic IT skills R 8: We recommend that the higher education institutions and professional bodies (such as the medical Royal Colleges) responsible for the different disciplines adapt their curricula to integrate the use and understanding of healthcare Information and communication technologies (ICTs) into the basic training and continuing professional development of healthcare professionals. R 9: We recommend that local and national health authorities ensure that sufficient funding and time are allocated to provide initial training and ongoing support for healthcare professionals. December 2006 | Digital healthcare The Royal Society 16 G. Defeudis, Bruxelles 2019 In addition to the basic training and continuing professional development, it is essential that healthcare professionals are given training and support on how to use new ICTs when they are introduced. Ongoing access to technical support is essential so that difficulties can be addressed quickly. With the expected increase in patiented care, patients and their carers should also be trained and have access to technical support where appropriate.

TRAINING Technology-enabled self-management (TES) feedback loop Effective technology-enabled self-management (TES) is facilitated by the TES feedback loop between a person with diabetes and their health care team. 4 key elements have been identified and defined the TES feedback loop that contributed to an improved A 1 c: (1) 2 -way communication, (2) PGHD analysis, (3) education, (4) feedback G. Defeudis, Bruxelles 2019 17 Greenwood DA et al. , J Diabetes Sci Technol. 2017

CONCLUSIONS WEB AND SOCIAL MEDIA ARE CHANGING THE RELATIONSHIP PHYSICIAN-PATIENT, AND DIGITAL HEALTH IS SPREADING UP, WITH PROS AND CONS. ABOUT PROS - SOME AND SELECTED SUBJECTS WITH A CHRONIC DISEASE, AS DIABETES, MAY IMPROVE THEIR GLYCEMIC CONTROL - ADVANTAGES ON ECONOMIC EXPENSE ABOUT CONS, SOLUTIONS ARE STRONGLY REQUIRED, AND STRICTLY CONNECTED TO EFFORT EDUCATION AND TRAINING OF PATIENTS AND PHYSICIANS TOO IMPROVE THE USE OF TECHNOLOGIES FOR A HAND MADE TAILORED USE, DEPENDING BY THE SINGLE PATIENT G. Defeudis, Bruxelles 2019 18

thank you Giuseppe Defeudis MD, Ph. D Italian Coordinator of Youngest of Italian Society of Diabetes (SID) Dept. Endocrinology & Diabetes University Campus Bio-Medico, Rome, Italy g. defeudis@unicampus. it 19