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

Active, not recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT06639100
• Lead Sponsor: AUSL Romagna Rimini

Brief Summary

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

Detailed Description

Diabetes is a pivot condition involving a range of complications and interventions from multiple care providers over a long period of time. For this reason, it represents a critical field of chronic care where person-centred models can be better implemented using real world data on a continuous basis to support research and clinical practice. These activities are extremely challenging to carry out at national level, due to the lack of standardised definitions and clear guidelines on privacy and data protection, data exchange and statistical processing. We propose to implement a Regional Surveillance System for person-centred care in Diabetes that will be sustainable, standardised, actionable, introducing a value-based approach, privacy enhanced, statistically fair (internationally comparable), and clinically transparent, whose performance outputs will be made publicly available. This will be an observational, exploratory study targeting a population of subjects with diabetes from 4 different geographical areas of Emilia- Romagna. The study population will be followed up by 4 participating centres for 612 months, which already collect demographics, anthropometric data and clinical records at the Diabetes Outpatient Clinics using the same electronic format and data management software (Smart Digital Clinic from Meteda). Measurements for the target population will be available on a rolling basis, as they will be recorded as a part of routine care during ordinary visits. Further information will be acquired using other administrative sources, through data linkage of available databases: hospital discharge records, pharmaceutical prescriptions in and out of hospital, specialist visits, payment exemption and the primary master index (mortality records).The project will enroll all patients from 4 operational units (Romagna, Ferrara, Reggio Emilia and Parma). The UO "Diabetology" at "Azienda USL della Romagna" has a capacity of a total patient pool of 28,000 consecutive patients per year. The UO "Diabetology" at Azienda USL Reggio Emilia has a capacity of a total patient pool of 40,000 consecutive patients per year. The UO "Endocrinologia e Malattie del Metabolismo" at Azienda Ospedaliero- Universitaria Parma has a capacity of a total patient pool of 2,500 consecutive patients per year. The UO "Diabetology" at Azienda USL Ferrara has a capacity of a total patient pool of 5,000 consecutive patients per year. All centres collect personal data, anthropometric and clinical records of the Diabetes Outpatient Clinic using the same electronic format and data management software (Smart Digital Clinic from Meteda). Therefore, measurements for the target population will be available on a continuous basis, as they will be recorded as a part of routine care during ordinary visits.

This basis will be used to select 1,600 consecutive patients that will be followed up expanding the range of items available through a specific activity of data collection in the areas of PROMs and Covid-19. Each operating unit will recruit 400 patients (\~100 with type 1 diabetes and \~300 with type 2 diabetes).

Study Timeline

• Study Start: 2022-04-27
• Primary Completion: 2023-04-27
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Study Completion: 2024-10-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Ausl della Romagna Direttore UO di Diabetologia; 🇮🇹 Ravenna, RA, Italy