This Will Be an Observational, Exploratory Study Targeting a Population of Subjects with Diabetes from 4 Different Geographical Areas of Emilia- Romagna.

NCT06639100 · tracked via the Priya Life Science Italy tracker

Sponsor

AUSL Romagna Rimini

Phase

Observational

Started

2022-04-27

Last updated

2024-10-15

Condition(s) studied

Diabetes Mellitus

Study summary

This will be an observational, exploratory study targeting a population of subjects with diabetes from 4 different geographical areas of Emilia- Romagna.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Eligible patients will be all those recorded in 4 operational units with an "active status", defined as those who attended a visit during the last three years or booked one in the course of the study. Participants will have T1D for at least 1 year and be aged ≥18 to \<40 years. Patients with type 2 diabetes will have diabetes for at least 1 year. PROMs will be measured among subjects aged ≥40 to \<70 years only. Exclusion Criteria: * Patients who deceased or migrated during the last three years prior to the start of the study. Furthermore, we will exclude pregnant women, patients with known and recorded cognitive deficiency (eg, Down's syndrome, Alzheimer), severe somatic comorbidity (eg, end-stage renal disease, severe heart failure, severe cancer), and/or a major psychiatric diagnosis (eg, severe depression or bipolar disorder, schizophrenia) as diabetes distress is often neither ethical nor possible to discuss with these groups of patients.

Primary outcome measure(s)

PROMs — 12 mouth
The primary outcome measure will be pre-post change in the 3 PROMs that will be measured in the study population. All items will be condensed for the whole population into observations at baseline (time 0) and, 6 months and one year. Patient reported outcomes (PROMs) will be collected at baseline and after 6 12 months. All data will be linked to the administrative records to build an all-embracing file, which, after anonymization of the data, will be used for statistical analysis. A specific study questionnaire including all questions for the validated PROMs will be filled at the clinical site, with the direct support of a specialised care providers. The questionnaire will be administered twice, at baseline and follow-up visit (after 6 12 months).

Trial sites (1)

Facility	City	Region	Status
Ausl della Romagna Direttore UO di Diabetologia	Ravenna	RA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06639100 on ClinicalTrials.gov ↗ ← All trials in Italy