Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:58 AM
Study NCT ID:
NCT07461805
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Type 1 Diabetes Subgroup: An Artificial Intelligence Analysis of Clinical and Glucometric Features
Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Organization:
Study Overview
Official Title:
Caracterización de Subgrupos de Personas Con Diabetes Tipo 1: análisis de características clínicas y glucométricas Utilizando Una aproximación de Inteligencia Artificial
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T1DC
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: