Clinical Trial

Development and Implementation of a Structured Therapeutic Education Program on the Use of Mobile Applications for People With Diabetes Mellitus.

Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated June 13, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
Introduction: Diabetes mellitus (DM) is a group of disorders characterized by chronic hyperglycemia due to issues with insulin production or function. Globally, the incidence is about 15 cases per 100,000 people, with a prevalence of 9.5%. In Spain, the highest prevalence rates are in the Canary Islands, Murcia, and Castilla y León. DM management includes a balanced diet, exercise, medication, and therapeutic education. Nurse-led programs improve patient outcomes, and mobile apps like Social Diabetes and MySugar help calculate insulin dosages based on diet and other factors. Methodology: The study will take place at the Hospital Universitario Virgen del Rocío in Seville, Spain. Participants will be selected based on eligibility criteria, including being over 18, having diabetes under basal-bolus treatment, and being able to use a mobile phone. Exclusion criteria include cognitive impairment and severe illnesses. The intervention includes a structured education program led by nurses using mobile apps, with 3 group sessions and one individual session at 6 months. The primary outcome is glycemic control, and secondary outcomes include self-efficacy and knowledge levels. The study requires 52 participants, with data collected by nurse educators and analyzed using SPSS. Ethics approval and informed consent will be obtained. The authors declare no conflicts of interest.
Trial Details
NCT Number NCT07019025
Lead Sponsor Hospitales Universitarios Virgen del Rocío
Conditions Diabetes Mellitus
Enrollment 52 participants
Start Date 2025-06-30
Primary Completion 2025-09 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-06-13