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Efficacy of a Digital Educational Intervention in Patients With Type 2 Diabetes Mellitus

NCT06850129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-02-27

No results posted yet for this study

Summary

The goal of this interventional study is to evaluate the change in the HbA1c value, changes in body composition and evaluation of response using validated questionnaires of satisfaction with healthcare professionals during 6 months follow-up.

The primary purpose of the study is to observe whether patients with a poor control of Diabetes type 2, in the digital intervention group through social networks can improve the control of their disease with quantifiable analytical values, as well as enhance their knowledge of the disease and its treatment, achieve greater satisfaction with healthcare professional and improve adherence to treatment.

The primary hyphotesis is that people with Type 2 Diabetes who participate in an educational intervention through digitalized systems and social networks achieve better metabolic control, including a reduction in HbA1c levels, improve their quality of life, expand their knowledge about disease management, and reduce healthcare resource utilization.

Conditions

  • Diabetes Mellitus Type 2

Interventions

BEHAVIORAL

DIGITAL INTERVENTION

All patients received specific information about DM, treatments and po-tential complications. Then, patients were randomized to the digital interven-tion group or usual care. Those patients randomized to the intervention group were educated in the use of different social networks with access to infor-mation related to healthy lifestyle habits, dietary support, optimization of physi-cal 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 re-solved.

Sponsors & Collaborators

  • HOSPITAL VITHAS SEVILLA

    lead NETWORK

Principal Investigators

  • Angel Vilches Arenas, Phd · Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2022-10-26
Completion
2023-10-26

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06850129 on ClinicalTrials.gov