An interventional study of Therapeutic patient education on the use of a insulin bolus calculator app in Diabetes Mellitus, sponsored by Hospitales Universitarios Virgen del Rocío. Not yet recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Hospitales Universitarios Virgen del Rocío · Not applicable, Interventional, and Other
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.
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 52 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hospitales Universitarios Virgen del Rocío is the lead sponsor of 33 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
Therapeutic patient education on the use of a insulin bolus calculator app
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)
Time frame: March 2025
Start is estimated for Jun 2025; primary completion for Sep 2025, 3 months later.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 3 months is below that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Hospitales Universitarios Virgen del Rocío