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 volunteersQualifiers
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
Case-only
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Type 1 diabetes clusters
Differentiated groups of people with type 1 diabetes defined through the analysis of clinical, analytical, and glucometric variables.
Secondary outcomes
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
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.
Glycemic control: mean glucose
Mean glucose reported in mg/dL
Glycemic control: GMI (glucose management indicator)
GMI (glucose management indicator) reported in percentage (%)
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