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Clinical Trials in Spain / NCT07019025
Starting soon Not applicable

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

NCT07019025 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospitales Universitarios Virgen del Rocío
Phase
Not applicable
Started
2025-06-30
Last updated
2025-06-13

Condition(s) studied

Diabetes Mellitus

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
The inclusion criteria will be to be over 18 years old with Diabetes Mellitus in bolus/basal treatment, to have and know how to use one's own mobile phone. The exclusion criteria will consist of cognitive impairment, having acute or worsening chronic diseases at the time of recruitment and lack of temporal and geographical availability.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario Virgen del Rocío Seville Sevilla

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07019025 on ClinicalTrials.gov ↗ ← All trials in Spain