Caracterización de Subgrupos de Personas Con Diabetes Tipo 1: análisis de características clínicas y glucométricas Utilizando Una aproximación de Inteligencia Artificial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Type 1 diabetes clusters
研究概览
简要总结
The goal of this observational study is to characterize different subgroups among patients with type 1 diabetes. The main research question is:
Are there distinct subtypes among people with type 1 diabetes?
Participants will be invited to take part in the study by allowing access to their health data. They will not be required to undergo any additional examinations, tests, visits, or interventions.
详细描述
Study Description
Main Objective The primary objective of this study is to characterize subgroups of individuals with type 1 diabetes (T1D) based on clinical and glucometric features using an artificial intelligence (AI) approach.
Secondary objectives Evaluate cluster stability over time (1, 2, and 3 years); assess cluster utility for predicting complications; analyze the contribution of different clinical variables to cluster characterization and its evolution over time; and model endpoints such as diabetes-related complications.
Study Design This is an ambispective observational study.
Disease Under Study Type 1 Diabetes Mellitus.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with type 1 diabetes (T1D) aged 18 years or older.
- •T1D individuals expected to have regular follow-up at the Endocrinology and Nutrition Department of Hospital de la Santa Creu i Sant Pau.
- •Users of continuous glucose monitoring (CGM) systems for at least the last 6 months of
- •Willingness and ability to provide written informed consent to participate in the study (by the patient or his/her representative).
排除标准
- •Presence of severe comorbidities or medical conditions that, in the investigator's judgment, could interfere with participation in the study or the interpretation of results. This circumstance is expected to be exceptional, as the study aims to be as inclusive as possible.
研究组 & 干预措施
People with type 1 diabetes mellitus
Individuals with type 1 diabetes mellitus (T1D) cared for at the Endocrinology and Nutrition Department of Hospital de la Santa Creu i Sant Pau.
结局指标
主要结局
Type 1 diabetes clusters
时间窗: Subgroups defined based on data from the year 2024.
Differentiated groups of people with type 1 diabetes defined through the analysis of clinical, analytical, and glucometric variables.
次要结局
- Glycemic control: CV (coefficient of variation)(2024-2027)
- Cluster stability over time(2024 - 2027)
- Acute and chronic diabetes complications(2024-2027)
- Glycemic control: mean glucose(2024-2027)
- Glycemic control: GMI (glucose management indicator)(2024-2027)
- Glycemic control: time in range(2024-2027)
- HbA1c(2024-2027)
- Lipid profile(2024-2027)
- Creatinine(2024-2027)
- Estimated glomerular filtration rate(2024-2027)
- Albuminuria(2024-2027)
- Antihypertensive treatment(2024-2027)
- Hypolipemiant treatment: use(2024-2027)
- Hypolipemiant treatment amongst clusters(2024-2027)
- Insulin treatment: type(2024-2027)
- Insulin treatment: association with the clusters(2024-2027)
- Anthropometric variables: weight(2024-2027)
- Anthropometric variables: height(2024-2027)
- Anthropometric variables: waist circumference(2024-2027)
- Substance use: tobacco(2024-2027)
- Substance use: alcohol(2024-2027)
- Age at diagnosis(2024-2027)
- Disease duration(2024-2027)
- Pregnancy(2024-2027)
- Parity status in women(2024-2027)
- Menstrual cycle phase(2024-2027)
- Reproductive stage in women(2024-2027)
- Patient-reported variables(2024-2027)
- Patient-reported variables and its association with the clusters(2024-2027)
- Sociodemographic variables(2024-2027)