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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

800 Participants
are grouped into 1 trial group
Group A: People with type 1 diabetes mellitus

Trial outcomes

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.

Time frame
Subgroups defined based on data from the year 2024.

Secondary outcomes

1

Cluster stability over time

Cluster stability over time determined using the Jaccard index as a reliability criterion: persistence of clusters over 1, 2, and 3 years. The Jaccard index (JI) measures the degree of similarity between two sets, regardless of the type of elements. It takes values between 0 and 1, with the latter corresponding to complete equality between both sets

Time frame
2024 - 2027
2

Acute and chronic diabetes complications

Presence of acute complications (such as severe hypoglycemia) and chronic complications (such as retinopathy, nephropathy, and neuropathy) across the different clusters.

Time frame
2024-2027
3

Glycemic control: mean glucose

Mean glucose reported in mg/dL

Time frame
2024-2027
4

Glycemic control: GMI (glucose management indicator)

GMI (glucose management indicator) reported in percentage (%)

Time frame
2024-2027

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Sociedad Española de Diabetes

Collaborator

Associació Catalana de Diabetis

Collaborator