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

NCT07019025 | Not Yet Recruiting

• 1 other identifier: MPSA-CB-2024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

diabetes; nurses

Outcome Measures

Primary Outcomes (1)

• Control glucémico

  The main outcome will be glycemic control through the values collected in the ambulatory glucose profile (AGP) report (time in range, time below range, time above range, coefficient of variability, average glucose, management indicator of glucose)

  March 2025

Study Arms (1)

Bolus calculation

EXPERIMENTAL

The intervention will consist of a structured therapeutic education program led and taught by nurses based on the use of mobile applications to manage glycemic control, reinforce self-efficacy and improve knowledge of the disease. It will be carried out over 3 face-to-face group sessions of a maximum of 5 consecutive people in the CDT, another with the same characteristics after 90 days and an individual telematic session after 6 months. The hospitalization or internalization of the person was established as criteria to interrupt or modify the intervention. To improve compliance with the protocol and intervention, periodic meetings will be agreed upon with the nurses in charge of education.

Other: Therapeutic patient education on the use of a insulin bolus calculator app

Interventions

Therapeutic patient education on the use of a insulin bolus calculator app OTHER

Therapeutic patient education on the use of a insulin bolus calculator app

Bolus calculation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Advanced Diabetes Nurse

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: June 13, 2025
• Study Start: June 30, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

ES (1)