Characterization of Type 1 Diabetes Subgroup: An Artificial Intelligence Analysis of Clinical and Glucometric Features

Caracterización de Subgrupos de Personas Con Diabetes Tipo 1: análisis de características clínicas y glucométricas Utilizando Una aproximación de Inteligencia Artificial

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.

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.

Methodology This ambispective observational study will use information extracted from participants' electronic medical records and glucometric data obtained from the corresponding monitoring platforms. The data will be analyzed using artificial intelligence techniques to identify patterns and potential subgroups within the type 1 diabetes population.

Study Population and Sample Size The study population includes individuals with type 1 diabetes (T1D) who are being followed at the Endocrinology and Nutrition Department of Hospital de la Santa Creu i Sant Pau. As this is an exploratory study, no formal sample size calculation is required. Approximately 800 patients are expected to be included.

Inclusion Criteria:

• 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 2024.
• Willingness and ability to provide written informed consent to participate in the study (by the patient or his/her representative).

Exclusion Criteria:

• 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.