Diabetes MellitusREWINDERNCT06639100
This Will Be an Observational, Exploratory Study Targeting a Population of Subjects with Diabetes from 4 Different Geographical Areas of Emilia- Romagna.
An observational study of Diabetes Mellitus, run by AUSL Romagna Rimini at 1 site in Italy.
Trial summary
This will be an observational, exploratory study targeting a population of subjects with diabetes from 4 different geographical areas of Emilia- Romagna. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 63,500 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2022to 26 Oct 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total population of 63,500 people with diabetes in 4 geographical areas of Emilia-Romagna.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Data and Patient Reported Outcomes in Diabetes: a Standard Set for Person-Centred Care in Emilia-Romagna During and After Covid-19
This will be an observational, exploratory study targeting a population of subjects with diabetes from 4 different geographical areas of Emilia- Romagna.
Read the 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).
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMs
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).
Measured: 12 mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start27 Apr 2022
- Primary completion27 Apr 2023
- Study completion26 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63,500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639100
- Sponsor's protocol ID
- REWINDER
- Acronym
- REWINDER
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carinci F, Messina R, Michelini M, Bici A, Berardo A, Dei Cas A, Iezzi E, Di Iorio CT, Gualdi S, Aldigeri R, Fantini MP, Bonadonna RC, Massi Benedetti M, Di Bartolo P. Real-world data and patient-reported outcomes in diabetes in Emilia-Romagna (REWINDER): protocol of a federated cohort study for the regional evaluation of quality of care during and after COVID-19. BMJ Open. 2025 Oct 23;15(10):e102401. doi: 10.1136/bmjopen-2025-102401.
PubMed 41130696
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Data and Patient Reported Outcomes in Diabetes: a Standard Set for Person-Centred Care in Emilia-Romagna During and After Covid-19
- ClinicalTrials.gov ID
- NCT06639100
- Acronym / sponsor ID
- REWINDER / REWINDER
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 63,500 participants (estimated)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 26 Oct 2024 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total population of 63,500 people with diabetes in 4 geographical areas of Emilia-Romagna.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PROMs
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 41130696Carinci F, Messina R, Michelini M, Bici A, Berardo A, Dei Cas A, Iezzi E, Di Iorio CT, Gualdi S, Aldigeri R, Fantini MP, Bonadonna RC, Massi Benedetti M, Di Bartolo P. Real-world data and patient-reported outcomes in diabetes in Emilia-Romagna (REWINDER): protocol of a federated cohort study for the regional evaluation of quality of care during and after COVID-19. BMJ Open. 2025 Oct 23;15(10):e102401. doi: 10.1136/bmjopen-2025-102401.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by AUSL Romagna Rimini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMs (time frame: 12 mouth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06639100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.