Diabetes Mellitus, Type 2MINDERNCT04589533
MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS (MINDER Study)
An observational study of Diabetes Mellitus, Type 2, run by Fadoi Foundation, Italy at 6 sites in Italy.
Trial summary
This is a national multicenter study that involves 54 Internal Medicine Units throughout Italy. It is designed as a replicate of two cross-sectional surveys interspersed with an educational program. The study is composed by three steps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- educational program
- How many people
- 4,320 participants
- Where
- 6 sitesItaly
- Study dates
- 19 Sep 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in Internal Medicine and with known diagnosis of diabetes.
Who may be able to join
- Age ≥18 years
- Known diagnosis of type-2 diabetes
- Informed Consent
Who cannot join
- Current treatment with insulin
- Patients treated with rapid acting insulin during the hospitalization
- Patients hospitalized for less than 5 days.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
Azienda Toscana Nord Ovest, Cecina
Cecina
MARTINA LOMBARDI
MARTINA LOMBARDI
- Recruiting
Po Nord "S. Maria Goretti"
Latina
GIUSEPPE CAMPAGNA
GIUSEPPE CAMPAGNA
- Recruiting
ASST Sette Laghi, Ospedale Confalonieri di Luino
Luino
TIZIANA ATTARDO
FRANCESCO DENTALI
- Recruiting
Ospedale Fatebenefratelli
Naples
ANDREA FONTANELLA
ANDREA FONTANELLA
- Recruiting
Usl Toscana Sud Est, Petruccioli
Pitigliano
ANDREA MONTAGNANI
ANDREA MONTAGNANI
- Recruiting
Presidio di Passirana ASST RHODENSE
Rho
PAOLA NOVATI
PAOLA NOVATI
About this study
Official title: MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS: A Multicenter Study Before & After Educational Program, With Cluster Randomization (MINDER Study)
This is a national multicenter study that involves 54 Internal Medicine Units throughout Italy. It is designed as a replicate of two cross-sectional surveys interspersed with an educational program. The study is composed by three steps. Phase 1 concerns a retrospective data collection pertaining to patients with known diagnosis of T2DM. In phase 2 an educational training (focused on current Diabetes Guidelines recommendations and based on possible deviations from the best clinical practice observed during phase1) will be conducted in 36 randomized centres out of the 54 ones enrolled (cluster randomization). The ratio 2:1 has been selected in order to offer to the majority of Centres the opportunity to undergo a program of training and maximize the potential positive effect of the educational program on patient management. Randomization will be performed at the beginning of the study. Centres will be selected according to their ability to prescribe all classes of antidiabetic drugs. Phase 3 will occur around 6 months after the training and concerns a new data collection mirroring the previous one. In the phase 1, as well as in the phase 3, the data collection will be based on the review of the medical records of the last 40 consecutive patients with T2DM hospitalized in each Centre of Internal Medicine (in total, 80 patients for each Centre). After a period of 6 months from the hospitalization, a phone call follow up will be performed to know the clinical status of the patient enrolled, if he/she has been re-hospitalized after the index admission and current diabetes treatment.
Read the detailed description
During phase 1 and phase 3, each Center will review the medical records of the last 40 patients (for each phase) with known T2DM and hospitalized for any cause. Therefore, being the data collection retrospective, patients will be managed according to routine clinical practice. During phase 2, 36 randomized centers, out of the 54 ones enrolled, will receive an educational intervention based on outreach visit (EOV), a 3-h face-to-face meeting between a trained diabetes specialist from outside the Center and the staff of the Center itself. This method was selected being considered as one of the most effective to modify professional practice and improve health care outcomes. In addition, at least 50% of the physicians who are part of the staff of the Center will receive distance learning (FAD). The contents of the educational program will be defined by the study Steering Committee, on the basis of guidelines, and possible deviations from the best medical practice detected during phase 1. In order to minimize the "awareness bias" (i.e. the possibility that participation to the project significantly influence clinical attitudes in phase 3), only one physician of the Centers of the "Control" group (not receiving EOV) will be made aware of the study design and procedures, and he/she will be eventually supported in the study data collection by nurses, or physicians who do not have the possibility of prescribing, in particular regarding the new categories of antidiabetic drugs.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- educational program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational programOther
The educational program will be based on: a outreach visit (a 3-h face-to-face meeting between a trained diabetes specialist from outside the Center and the staff of the Center itself) and a distance learning (FAD).The educational programme will be focused on current Diabetes Guidelines recommendations and based on possible deviations from the best clinical practice observed during phase1
| Study group | Role | What they receive |
|---|---|---|
| EDUCATIONAL PROGRAM GROUP | This group will receive an educational program based . This group, as the other group, during phase 1 and phase 3, will review the medical records of the last 40 patients (for each phase) with known T2DM and hospitalized for any cause. Receives: Other: educational program | |
| CONTROL GROUP | Control group will not receive educational program. This group, as the other group, during phase 1 and phase 3, will review the medical records of the last 40 patients (for each phase) with known T2DM and hospitalized for any cause. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in fasting glycemia between the two groups of Centres during phase 3 of the study
The primary measure will be the variation in fasting glycemia (i.e. calculated by the difference between the fasting glicemia measured ad the admission and the fasting glicemia measured at the hospital discharge) during hospitalization between the two groups of Centres (those receiving and not receiving the educational program) during phase 3 of the study
Measured: 18 months
Secondary outcomes (2)
Variation in fasting glycemia during hospitalization between the phase 1 and phase 3
To evaluate the variation in fasting glycemia (i.e. calculated by the difference between the fasting glicemia measured ad the admission and the fasting glicemia measured at the hospital discharge) during hospitalization between the phase 1 and phase 3 in the two groups of Centres (those receiving and not receiving the educational program)
Measured: 18 months
Description of characteristics of patients with T2DM hospitalized in Internal Medicine
To describe the characteristics of patients with T2DM hospitalized in Internal Medicine and their treatment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start19 Sep 2019
- Primary completion1 Nov 2022 (estimated)
- Study completion31 Dec 2022 (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 Mellitus, Type 2Studies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANDREA FONTANELLA, Study director, FADOI FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589533
- Sponsor's protocol ID
- FADOI.01.2020
- Acronym
- MINDER
- Status last verified
- Feb 2022
- First submitted
- 7 Oct 2020
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceriello A, Fontanella A, Attardo TM, Beltramello G, Fierro A, Prattichizzo F, Pellegrini V, Fiore MS, De Menis E, Maffettone A, Magnani L, Pastorelli R, Ventrella F, Rondana M, Maurantonio M, Scanferlato M, Finizola F, Salvia MA, Nevola R, Prampolini G, Laccetti M, Mastroianni F, Cartabellotta F, Zagarri E, Dentali F, Manfellotto D; FADOI-MINDER Study Group. Management of subjects with type 2 diabetes hospitalized in internal medicine units: a cluster-randomized, multicenter study before and after an educational program. Intern Emerg Med. 2026 Apr;21(3):895-905. doi: 10.1007/s11739-025-04238-1. Epub 2026 Mar 13.
PubMed 41824238
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS: A Multicenter Study Before & After Educational Program, With Cluster Randomization (MINDER Study)
- ClinicalTrials.gov ID
- NCT04589533
- Acronym / sponsor ID
- MINDER / FADOI.01.2020
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,320 participants (estimated)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Oct 2020 (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 is a national multicenter study that involves 54 Internal Medicine Units throughout Italy. It is designed as a replicate of two cross-sectional surveys interspersed with an educational program. The study is composed by three steps. Phase 1 concerns a retrospective data collection pertaining to patients with known diagnosis of T2DM. In phase 2 an educational training (focused on current Diabetes Guidelines recommendations and based on possible deviations from the best clinical practice observed during phase1) will be conducted in 36 randomized centres out of the 54 ones enrolled (cluster randomization). The ratio 2:1 has been selected in order to offer to the majority of Centres the opportunity to undergo a program of training and maximize the potential positive effect of the educational program on patient management. Randomization will be performed at the beginning of the study. Centres will be selected according to their ability to prescribe all classes of antidiabetic drugs. Phase 3 will occur around 6 months after the training and concerns a new data collection mirroring the previous one. In the phase 1, as well as in the phase 3, the data collection will be based on the review of the medical records of the last 40 consecutive patients with T2DM hospitalized in each Centre of Internal Medicine (in total, 80 patients for each Centre). After a period of 6 months from the hospitalization, a phone call follow up will be performed to know the clinical status of the patient enrolled, if he/she has been re-hospitalized after the index admission and current diabetes treatment.
Detailed description
During phase 1 and phase 3, each Center will review the medical records of the last 40 patients (for each phase) with known T2DM and hospitalized for any cause. Therefore, being the data collection retrospective, patients will be managed according to routine clinical practice. During phase 2, 36 randomized centers, out of the 54 ones enrolled, will receive an educational intervention based on outreach visit (EOV), a 3-h face-to-face meeting between a trained diabetes specialist from outside the Center and the staff of the Center itself. This method was selected being considered as one of the most effective to modify professional practice and improve health care outcomes. In addition, at least 50% of the physicians who are part of the staff of the Center will receive distance learning (FAD). The contents of the educational program will be defined by the study Steering Committee, on the basis of guidelines, and possible deviations from the best medical practice detected during phase 1. In order to minimize the "awareness bias" (i.e. the possibility that participation to the project significantly influence clinical attitudes in phase 3), only one physician of the Centers of the "Control" group (not receiving EOV) will be made aware of the study design and procedures, and he/she will be eventually supported in the study data collection by nurses, or physicians who do not have the possibility of prescribing, in particular regarding the new categories of antidiabetic drugs.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDUCATIONAL PROGRAM GROUP | – | Other: educational programThis group will receive an educational program based . This group, as the other group, during phase 1 and phase 3, will review the medical records of the last 40 patients (for each phase) with known T2DM and hospitalized for any cause. |
| CONTROL GROUP | – | –Control group will not receive educational program. This group, as the other group, during phase 1 and phase 3, will review the medical records of the last 40 patients (for each phase) with known T2DM and hospitalized for any cause. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Internal Medicine and with known diagnosis of diabetes.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Known diagnosis of type-2 diabetes
- Informed Consent
Key exclusion criteria (3 listed)
- Current treatment with insulin
- Patients treated with rapid acting insulin during the hospitalization
- Patients hospitalized for less than 5 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational programThe educational program will be based on: a outreach visit (a 3-h face-to-face meeting between a trained diabetes specialist from outside the Center and the staff of the Center itself) and a distance learning (FAD).The educational programme will be focused on current Diabetes Guidelines recommendations and based on possible deviations from the best clinical practice observed during phase1 | Other | EDUCATIONAL PROGRAM GROUP |
Primary outcome
Variation in fasting glycemia between the two groups of Centres during phase 3 of the study
Time frame: 18 months
The primary measure will be the variation in fasting glycemia (i.e. calculated by the difference between the fasting glicemia measured ad the admission and the fasting glicemia measured at the hospital discharge) during hospitalization between the two groups of Centres (those receiving and not receiving the educational program) during phase 3 of the study
2 secondary outcomes
Variation in fasting glycemia during hospitalization between the phase 1 and phase 3
Time frame: 18 months
Description of characteristics of patients with T2DM hospitalized in Internal Medicine
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Derived from this study: PubMed 41824238Ceriello A, Fontanella A, Attardo TM, Beltramello G, Fierro A, Prattichizzo F, Pellegrini V, Fiore MS, De Menis E, Maffettone A, Magnani L, Pastorelli R, Ventrella F, Rondana M, Maurantonio M, Scanferlato M, Finizola F, Salvia MA, Nevola R, Prampolini G, Laccetti M, Mastroianni F, Cartabellotta F, Zagarri E, Dentali F, Manfellotto D; FADOI-MINDER Study Group. Management of subjects with type 2 diabetes hospitalized in internal medicine units: a cluster-randomized, multicenter study before and after an educational program. Intern Emerg Med. 2026 Apr;21(3):895-905. doi: 10.1007/s11739-025-04238-1. Epub 2026 Mar 13.
- 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.
ANDREA FONTANELLA study director
FADOI FOUNDATION
6 sites 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, Type 2, run by Fadoi Foundation, Italy at 6 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ELISA ZAGARRI' (+393387063726, elisa.zagarri@fadoi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in fasting glycemia between the two groups of Centres during phase 3 of the study (time frame: 18 months). 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 NCT04589533, 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 25 Feb 2022.