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

NCT07461805 | Recruiting

• 1 other identifier: IIBSP-GIA-2024-115
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial intelligence; glucometry; Clusters; Type 1 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Type 1 diabetes clusters

  Differentiated groups of people with type 1 diabetes defined through the analysis of clinical, analytical, and glucometric variables.

  Subgroups defined based on data from the year 2024.

Secondary Outcomes (32)

• 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: CV (coefficient of variation)

  2024-2027

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of individuals with type 1 diabetes (T1D) cared for at the Endocrinology and Nutrition Department of Hospital de la Santa Creu i Sant Pau.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Sociedad Española de Diabetes: collaborator
• Associació Catalana de Diabetis: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau, Barcelona, Barcelona 08041

Barcelona, Barcelona, 08025, Spain

RECRUITING

Related Publications (13)

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• Kovatchev B, Lobo B. Clinically Similar Clusters of Daily Continuous Glucose Monitoring Profiles: Tracking the Progression of Glycemic Control Over Time. Diabetes Technol Ther. 2023 Aug;25(8):519-528. doi: 10.1089/dia.2023.0117.

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  PMID: 37794253 BACKGROUND

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rosa M Corcoy

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Safont, MD

CONTACT

+34686203964; esafont@santpau.cat

Rosa M Corcoy, MD, PhD

CONTACT

+34686203964; rcorcoy@santpau.cat

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: March 10, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2025-11

Locations

ES (1)