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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07019025
Enrollment
52
Registered
2025-06-13
Start date
2025-06-30
Completion date
2025-09-30
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

diabetes, nurses

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.

Detailed description

Introduction: Diabetes mellitus (DM) comprises a group of metabolic disorders characterized by chronic hyperglycemia due to abnormalities in insulin production or function. Globally, the incidence is approximately 15 cases per 100,000 people, with a prevalence of 9.5%. In Spain, there is significant prevalence among adults and children, with the highest rates observed in the Canary Islands, Murcia, and Castilla y León. DM management focuses on a balanced diet, physical exercise, pharmacological treatment, and therapeutic education to reduce morbidity and mortality. Nurse-led therapeutic education programs have proven effective in improving self-control and health outcomes in DM patients. Mobile applications like Social Diabetes and MySugar have gained relevance, facilitating the calculation of necessary insulin boluses according to carbohydrate intake and other parameters. Objective: To analyze the effect of a structured therapeutic education program on glycemic control, self-efficacy, and knowledge in people with diabetes mellitus under basal-bolus treatment. A specific objective is to design and implement a structured therapeutic education program for adjusting insulin boluses relative to diet using mobile apps. The study will be conducted as a longitudinal inferential research with random assignment. Methodology: The study will be conducted at the Diagnostic and Treatment Center of Hospital Universitario Virgen del Rocío (HUVR) in Seville, Spain. Participants will be selected following nurse assessment of eligibility criteria. Inclusion criteria include being over 18 years old with diabetes mellitus under basal-bolus treatment and owning and being able to use a mobile phone. Exclusion criteria include cognitive impairment, having acute or chronic exacerbated illnesses at recruitment, and lack of temporal and geographical availability. The intervention will consist of a structured therapeutic education program led by nurses using mobile applications. It will be conducted in 3 group sessions and one individual telematic session at 6 months. The primary outcome will be glycemic control measured through the ambulatory glucose profile (AGP). Secondary outcomes will measure self-efficacy and knowledge levels. The required sample size was calculated to be 52 participants. Data collection will be carried out by nurse educators and analyzed using SPSS version 29. Approval from the Biomedical Research Ethics Committee of Andalusia will be sought, and informed consent will be obtained from participants. The authors declare no conflicts of interest.

Interventions

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

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

Sponsors

Hospitales Universitarios Virgen del Rocío
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Control glucémicoMarch 2025The 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)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026