MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS (MINDER Study)
MINDER
1 other identifier
observational
4,320
1 country
6
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2019
CompletedFirst Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 25, 2022
February 1, 2022
3.1 years
October 7, 2020
February 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
18 months
Secondary Outcomes (2)
Variation in fasting glycemia during hospitalization between the phase 1 and phase 3
18 months
Description of characteristics of patients with T2DM hospitalized in Internal Medicine
18 months
Study Arms (2)
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.
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.
Interventions
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
Eligibility Criteria
Patients hospitalized in Internal Medicine and with known diagnosis of diabetes.
You may qualify if:
- Age ≥18 years
- Known diagnosis of type-2 diabetes
- Informed Consent
You may not qualify if:
- Current treatment with insulin
- Patients treated with rapid acting insulin during the hospitalization
- Patients hospitalized for less than 5 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Azienda Toscana Nord Ovest, Cecina
Cecina, Italy
Po Nord "S. Maria Goretti"
Latina, Italy
ASST Sette Laghi, Ospedale Confalonieri di Luino
Luino, Italy
Ospedale Fatebenefratelli
Napoli, Italy
Usl Toscana Sud Est, Petruccioli
Pitigliano, Italy
Presidio di Passirana ASST RHODENSE
Rho, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ANDREA FONTANELLA
FADOI FOUNDATION
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 19, 2020
Study Start
September 19, 2019
Primary Completion
November 1, 2022
Study Completion
December 31, 2022
Last Updated
February 25, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share