Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT04589533
Status:
UNKNOWN
Last Update Posted:
2022-02-25
First Post:
2020-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS (MINDER Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation in fasting glycemia between the two groups of Centres during phase 3 of the study', 'timeFrame': '18 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Variation in fasting glycemia during hospitalization between the phase 1 and phase 3', 'timeFrame': '18 months', 'description': '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)'}, {'measure': 'Description of characteristics of patients with T2DM hospitalized in Internal Medicine', 'timeFrame': '18 months', 'description': 'To describe the characteristics of patients with T2DM hospitalized in Internal Medicine and their treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in Internal Medicine and with known diagnosis of diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years\n2. Known diagnosis of type-2 diabetes\n3. Informed Consent\n\nExclusion Criteria:\n\n1. Current treatment with insulin\n2. Patients treated with rapid acting insulin during the hospitalization\n3. Patients hospitalized for less than 5 days.'}, 'identificationModule': {'nctId': 'NCT04589533', 'acronym': 'MINDER', 'briefTitle': 'MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS (MINDER Study)', 'organization': {'class': 'OTHER', 'fullName': 'Fadoi Foundation, Italy'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'FADOI.01.2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EDUCATIONAL PROGRAM GROUP', 'description': '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.', 'interventionNames': ['Other: educational program']}, {'label': 'CONTROL GROUP', 'description': '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': [{'name': 'educational program', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['EDUCATIONAL PROGRAM GROUP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cecina', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'MARTINA LOMBARDI', 'role': 'CONTACT'}, {'name': 'MARTINA LOMBARDI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Toscana Nord Ovest, Cecina', 'geoPoint': {'lat': 43.30621, 'lon': 10.51729}}, {'city': 'Latina', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'GIUSEPPE CAMPAGNA', 'role': 'CONTACT'}, {'name': 'GIUSEPPE CAMPAGNA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Po Nord "S. Maria Goretti"', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'city': 'Luino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'TIZIANA ATTARDO', 'role': 'CONTACT'}, {'name': 'FRANCESCO DENTALI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Sette Laghi, Ospedale Confalonieri di Luino', 'geoPoint': {'lat': 46.00185, 'lon': 8.74512}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'ANDREA FONTANELLA', 'role': 'CONTACT'}, {'name': 'ANDREA FONTANELLA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Fatebenefratelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Pitigliano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'ANDREA MONTAGNANI', 'role': 'CONTACT'}, {'name': 'ANDREA MONTAGNANI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Usl Toscana Sud Est, Petruccioli', 'geoPoint': {'lat': 43.45, 'lon': 11.93333}}, {'city': 'Rho', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'PAOLA NOVATI', 'role': 'CONTACT'}, {'name': 'PAOLA NOVATI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Presidio di Passirana ASST RHODENSE', 'geoPoint': {'lat': 45.53245, 'lon': 9.0402}}], 'centralContacts': [{'name': "ELISA ZAGARRI'", 'role': 'CONTACT', 'email': 'elisa.zagarri@fadoi.org', 'phone': '+393387063726'}], 'overallOfficials': [{'name': 'ANDREA FONTANELLA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FADOI FOUNDATION'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fadoi Foundation, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}