NCT06290544

Brief Summary

This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Nov 2021Jul 2026

Study Start

First participant enrolled

November 29, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 4, 2024

Status Verified

October 1, 2023

Enrollment Period

4.6 years

First QC Date

March 30, 2023

Last Update Submit

February 26, 2024

Conditions

Diabetes Mellitus, Type 1Cardiovascular Diseases

Keywords

DiabetesDiabetes Mellitus, Type 1Cardiovascular riskCardiovascular Diseases

Outcome Measures

Primary Outcomes (3)

  • Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines.

    Evaluation of cardiovascular risk class for type 1 diabetic patients using ESC/EASD stratification according to disease duration

    5 years

  • Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE).

    Evaluation of cardiovascular risk class for type 1 diabetic patients using The Steno Type 1 Risk Engine algorithm

    5 years

  • Prevalence of cardiovascular disease in type 1 diabetes patients

    Prevalence of cardiovascular disease in T1DM cohort defined as one of the following: * acute mycardial infarction * ischemic stroke * peripheral artery disease * coronary, carotid or peripheral artery revascularization * presence of clinically significant stenosis in coronary CT and/or in carotid ultrasound assessment.

    5 years

Secondary Outcomes (11)

  • Prevalence of diabetic retinopathy

    5 years

  • Prevalence of diabetic nephropathy

    5 years

  • Prevalence of diabetic neuropathy

    5 years

  • CT-derived calcium score

    5 years

  • Carotid intima-media thickness

    5 years

  • +6 more secondary outcomes

Study Arms (1)

Single arm study

OTHER

Subjects with type 1 diabetes mellitus who meet all the inclusion and none exclusion criteria

Other: Standard of care plus additional examinations

Interventions

Standard of care plus additional examinationsOTHER

The patient will undergo good clinical practice examinations according to guidelines plus The patient will undergo to the evaluation of endothelial dysfunction with ENDOPAT 2000 and whole blood sampling for future omics studies

Single arm study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 1 diabetes mellitus.
  • Age ≥ 18 years.
  • Signed Informed consent

You may not qualify if:

  • Age \< 18 years.
  • Pregnancy in progress.
  • Type 2 diabetes mellitus.
  • Secondary diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS Centro Cardiologico Monzino

Milan, 20138, Italy

RECRUITING

Policlinico di Monza

Monza, 20900, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Cardiovascular DiseasesDiabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Stefano Genovese, MD

    IRCCS Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Genovese, MD

CONTACT

+390258002327stefano.genovese@cardiologicomonzino.it

Maurizio Rondinelli, MD

CONTACT

+390258002040maurizio.rondinelli@cardiologicomonzino.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

March 4, 2024

Study Start

November 29, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 4, 2024

Record last verified: 2023-10

Locations

IT(2)