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临床试验/NCT07019025
NCT07019025尚未招募不适用

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

Hospitales Universitarios Virgen del Rocío1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
Control glucémico

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •will consist of cognitive impairment, having acute or worsening chronic diseases at the time of recruitment and lack of temporal and geographical availability.

研究组 & 干预措施

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.

干预措施: Therapeutic patient education on the use of a insulin bolus calculator app (Other)

结局指标

主要结局

Control glucémico

时间窗: March 2025

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)

次要结局

未报告次要终点

研究者

发起方
Hospitales Universitarios Virgen del Rocío
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pilar Santa Cruz Álvarez

MSc, Advanced Diabetes Nurse

Hospitales Universitarios Virgen del Rocío

研究点 (1)

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