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临床试验/NCT05143411
NCT05143411已完成不适用

Evaluation of a Mobile Application to Optimize Decision-making in Self-management and Reduction of Complications in Persons With Type 1 Diabetes

Universidad Iberoamericana2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Change in glucose levels

研究概览

简要总结

Adolescents with type 1 diabetes mellitus (T1 DM) tend to have poor metabolic control. There are no mobile applications in our language in our environment, and patients are accessible in addition to the difficulties involved in these manual calculations. One way to bridge the knowledge gaps in T1 DM self-management is by using technology to optimize metabolic control and reduce the risks of associated comorbidities, with a mobile application that helps optimize decision-making in self-management. This research aims to help people with type 1 diabetes to change the glycemic blood levels and to be able to calculate the food together with the amount of insulin with food from the region. To evaluate the acceptability and effectiveness of the application, the investigators will carry out a pilot evaluation test. The participants in this pilot test will be 20 people between 14 and 18 years old with T1DM, users of the pediatric diabetology service of the National Institute of Diabetes, Endocrinology, and Nutrition (INDEN).

详细描述

Metabolic lack of control in patients with type 1 diabetes Mellitus (T1DM) leads to kidney failure, non-traumatic amputations, blindness, and reduced life expectancy. In addition, determining the content of macronutrients in food is not the domain of many patients, particularly adolescents, or some physicians, making insulin adjustment difficult, one of the main failures of optimal metabolic control. One way to bridge the knowledge gaps in T1D self-management is by using technology to optimize metabolic control and reduce the risks of associated comorbidities, with a mobile application that helps optimize decision-making in self-management. And a reduction of complications in adolescents (14-18 years) with T1DM. This project aims to develop this application that contributes to decision-making and the reduction of comorbidities of adolescents with T1DM, following the policies of the Dominican state through Digital systems, together with its educational mission, technological access, and national competitiveness.

There are no mobile applications in use in the Dominican Republic for the self-management of chronic diseases. Therefore, the investigators have designed a mobile application with a postprandial insulin bolus calculator. In addition, the developers has added a list of foods from the region where users can select their foods and adjust them with the amount of insulin to metabolize them. The methodology includes a mixed approach (qualitative and quantitative) before starting the study and after three months of using the application.

To evaluate the acceptability and effectiveness of the application, we will carry out a pilot evaluation test. The participants in this pilot test will be 20 people between 14 and 18 years old with T1DM, users of INDEN. This experimental study has a systematized probabilistic sample from the center's master list. They were randomized, not controlled. Therefore, the participants are users of the pediatric diabetology service, and included prior explanation and approval of informed consent. These 20 participants will be recruited, ensuring the equitable distribution between gender and sociodemographic data of the mentioned group while maintaining the intention to treat.

Inclusion criteria:

-Patients between 14-18 years old with diabetes type 1.

研究设计

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

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Persons with diabetes type 1

排除标准

  • Persons with oral diabetes treatment.
  • Glomerular filtration rate less than 60 mL/min

结局指标

主要结局

Change in glucose levels

时间窗: Day 01, Month 01

We expect to find changes in glucose levels before each main meal

次要结局

  • Change in glycemic variability(Day 01, month 3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenny Lujan Cepeda Marte

Doctor

Universidad Iberoamericana

研究点 (2)

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