This Will Be an Observational, Exploratory Study Targeting a Population of Subjects with Diabetes… (NCT06639100) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
This Will Be an Observational, Exploratory Study Targeting a Population of Subjects with Diabetes from 4 Different Geographical Areas of Emilia- Romagna.
Italy63,500 participantsStarted 2022-04-27
Plain-language summary
This will be an observational, exploratory study targeting a population of subjects with diabetes from 4 different geographical areas of Emilia- Romagna.
Who can participate
Age range40 Years
SexALL
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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.