Efficacy of a Digital Educational Intervention in Patients With Type 2 Diabe-tes Mellitus. A Multicenter, Randomized and Prospective 6-month Follow-up Study

This was a multicenter, randomized, prospective and interventional study that included adults with T2DM that started treatment with GLP-1 receptor agonists, had poor metabolic control (HbA1c >7%), were able to use a smartphone-based home digital tool, and access to social networks and webinars focus on diabetes education. In addition, the patients had to be on stable doses of oral antidiabetics for at least the previous 90 days. By contrast, patients with lack of motivation or unable to use social networks, unable to read or write in Spanish, previous history of psychiatric disorder or serious organic disease, using systemic corticosteroids (>10 days in treatment), or being pregnant, were excluded. Outpatients were recruited during one year from the Endocrinology Depart-ments of the Virgen Macarena Hospital (Seville), and Juan Ramón Jiménez Hospital (Huelva).

All patients received specific information about DM, treatments and potential complications. Then, patients were randomized to the digital intervention group or usual care. Those patients randomized to the intervention group were educated in the use of different social networks with access to information re-lated to healthy lifestyle habits, dietary support, optimization of physical activity, insulin titration, therapeutic targets, self-care, based on validated material from scientific societies and endorsed in diabetes education. Patients also had the valuable resource of a Digital Diabetes Coach: an online expert specializing in therapeutic education. This virtual guide provided patients with the flexibility to interact in both unidirectional and bidirectional ways, using methods such as chat boxes, audio messages, videos, and more. Through this digital medium, patients could seek guidance and have their questions resolved. The Digital Diabetes Coach operated under the supervision of a multidisciplinary team, endocrinologists, nutritionists, and certified diabetes educators. This team en-sured that patients received comprehensive support and guidance tailored to their individual needs. Patient interactions were facilitated through a variety of digital platforms, which were selected based on the patient's preferences and in consultation with their Digital Diabetes Coach. These interactions aimed to provide essential support and motivation for patients. The communication channels employed included email, Skype, WhatsApp, telephone calls, and video conferencing, allowing for flexibility and convenience in connecting with patients. The main communication channels used in this study included tele-phone calls, WhatsApp, email and Skype video calls. Among them, WhatsApp was the preferred application by patients to ask questions and share information with professionals, regardless of their educational and socioeconomic level. Patients with higher educational levels also felt comfortable with communication through videoconferencing, while this medium was not the most desired by patients with a lower educational level or those from rural areas. In addition, webinars through Instagram in real time or recorded were also used. Furthermore, a comprehensive diabetes education program was introduced on a weekly basis, with 30-45 minutes sessions. This program covered a wide spectrum of critical topics, including proper injection techniques, dosage adjustments for medications, strategies for managing adverse events, personalized recommendations for physical activity, guidance on blood glucose profiling and interpretation, strategies for handling hypoglycemia and hyperglycemia, portion controlled dietary plans, and insights into potential health conditions associated with poor macro and microvascular control. The educational materials used for these sessions were sourced from scientific societies, external companies endorsed by these societies, as well as materials developed by our center. To ensure effective communication and timely assistance, a two-way communication system was established. Patients were encouraged to seek answers to their questions and access information on-demand through messenger apps and other digital platforms. This approach allowed for a responsive and patient-centered approach to addressing individual needs and concerns. During the different interventions, patients were promoted to send data on weight, capillary blood glucose, activation of pedometers on their mobile phone etc.

In the control group, visits to the specialists (i.e., endocrinologist) were performed every 3 months, that included diabetes education intervention by the nursing staff (i.e., use of medication, adherence to treatment and basic guidelines for the management of their diabetes), for around 30 minutes in each consultation.

At baseline, demographic data, educational level, employment status, physical examination, treatment for diabetes (total insulin dose), and analytical data within the 12 weeks before inclusion were collected. Data was obtained from each electronic clinical history and glucose levels from the Libreview system. During the intermediate visit (3 months±15 days from base-line), physical examination, number of scans, adherence, verification that the patient adequately understood the material delivered and made use of social networks, changes of treatment, regular diabetes education, and adverse events since last visit were recorded. As this was a routine visit, the education activities by the staff (nursing and endocrine specialist) were homogeneous in both groups. At study end (6 months±15 days from baseline), physical examination, number of scans, adherence, verification that the patient adequately understood the material delivered and made use of social networks, changes of treatment, regular diabetes education and adverse events since last visit were recorded. For changes of treatment, the total dose of insulin was considered, rather than maximum or minimum doses of insulin. Changes in body composition along the study were also analyzed, including body fat mass, visceral fat area, fat-free mass and skeletal muscle mass, through segmental analysis of multi-frequency bioelectrical impedance (SMF-BIA; Inbody 770, In-body Co,Ltd, Korea).

Additionally, at baseline and at study end, different validated questionnaires were fulfilled by the patients.