MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS (MINDER Study) (MINDER)

February 9, 2022 updated by: Fadoi Foundation, Italy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Cecina, Italy
        • Recruiting
        • Azienda Toscana Nord Ovest, Cecina
        • Contact:
          • MARTINA LOMBARDI
        • Principal Investigator:
          • MARTINA LOMBARDI
      • Latina, Italy
        • Recruiting
        • Po Nord "S. Maria Goretti"
        • Contact:
          • GIUSEPPE CAMPAGNA
        • Principal Investigator:
          • GIUSEPPE CAMPAGNA
      • Luino, Italy
        • Recruiting
        • ASST Sette Laghi, Ospedale Confalonieri di Luino
        • Principal Investigator:
          • Francesco Dentali
        • Contact:
          • TIZIANA ATTARDO
      • Napoli, Italy
        • Recruiting
        • Ospedale Fatebenefratelli
        • Contact:
          • ANDREA FONTANELLA
        • Principal Investigator:
          • ANDREA FONTANELLA
      • Pitigliano, Italy
        • Recruiting
        • Usl Toscana Sud Est, Petruccioli
        • Contact:
          • ANDREA MONTAGNANI
        • Principal Investigator:
          • ANDREA MONTAGNANI
      • Rho, Italy
        • Recruiting
        • Presidio di Passirana ASST RHODENSE
        • Contact:
          • PAOLA NOVATI
        • Principal Investigator:
          • PAOLA NOVATI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in Internal Medicine and with known diagnosis of diabetes.

Description

Inclusion Criteria:

  1. Age ≥18 years
  2. Known diagnosis of type-2 diabetes
  3. Informed Consent

Exclusion Criteria:

  1. Current treatment with insulin
  2. Patients treated with rapid acting insulin during the hospitalization
  3. Patients hospitalized for less than 5 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: educational program
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
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Variation in fasting glycemia during hospitalization between the phase 1 and phase 3
Time Frame: 18 months
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)
18 months
Description of characteristics of patients with T2DM hospitalized in Internal Medicine
Time Frame: 18 months
To describe the characteristics of patients with T2DM hospitalized in Internal Medicine and their treatment
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fadoi Foundation, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FADOI.01.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on educational program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings