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Trial record 1 of 2 for:    17683100 [PUBMED-IDS]
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Governance of Diabetes Management in Non-specialistic Hospital Settings

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ClinicalTrials.gov Identifier: NCT02640768
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Ivana Zavaroni, Azienda Ospedaliero-Universitaria di Parma

Brief Summary:
The prevalence of diabetes among inpatients in medical wards, surgery and intensive care units in Italy is approximatively 12-25%. The management of in hospital diabetes and hyperglycemia is complex and requires a specific training for physicians and nurses in non-specialist settings. The overall project aims at the implementation of a "best practice" model of care for hospitalized diabetic patients in non-specialist settings.

Condition or disease Intervention/treatment Phase
Diabetes Other: educational training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Governance of Diabetes Management in Non-specialistic Hospital Settings
Study Start Date : January 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: educational training
educational training
Other: educational training
implementation of a structured educational program for physicians and nurses

No Intervention: no educational training
no educational training wards



Primary Outcome Measures :
  1. Composite performance score computed as the sum of the performance scores of all 5 domains of appropriateness and efficacy in both the intervention and the control wards [ Time Frame: 11 months ]
    Efficacy of educational training will be evaluated as absolute change of the performance scores after the intervention compared to baseline in the two groups


Secondary Outcome Measures :
  1. hypoglycemic events in the intervention and control wards [ Time Frame: 11 months ]
    rate difference of hypoglycemia events (blood glucose ≤ 70 mg/dl) in the intervention and control wards

  2. severe hypoglycemic events in the intervention and control wards [ Time Frame: 11 months ]
    rate difference of severe hypoglycemia events (blood glucose ≤ 40 mg/dL with or without clouding of consciousness) in the intervention and control wards

  3. difference between plasma glycemia at admission and mean plasma glucose during the last-48-hours before discharge [ Time Frame: 11 months ]
    difference between plasma glycemia at admission and mean plasma glucose during the last-48-hours before discharge

  4. achievement of glycemic goals in the intervention and control wards [ Time Frame: 11 months ]
    number of patients that achieve glycemic goals: 4 consecutive blood glucose levels ≤ 130 mg/dl (preprandial) or ≤ 180 mg/dl (postprandial), or 4 consecutive blood glucose levels between 140 and 180 mg/dl in critically ill patients

  5. survival rate during hospitalization in the intervention and control wards [ Time Frame: 11 months ]
    survival rate during hospitalization (score 1 for survival, score 0 for death)

  6. discharge condition in the intervention and control wards [ Time Frame: 11 months ]
    a score of 0 will be assigned in case of death or transfer to a higher intensity ward and score 1 in all other cases, i.e. home discharge or transferral to a lower intensity ward.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with type 2 or type 1 diabetes or stress hyperglycemia

Exclusion Criteria:

  • age <18,
  • patients hospitalized for diabetic complications: ketoacidosis, hyperosmolar syndrome, hypoglycemic coma, pregnant diabetics or gestational diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640768


Locations
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Italy
AUSL Ospedale Maggiore
Bologna, Italy
Azienda Ospedaliero-Universitaria
Ferrara, Italy, 44121
AUSL Carpi
Modena, Italy
Azienda Ospedaliero-Universitaria Parma
Parma, Italy, 43126
AUSL Piacenza
Piacenza, Italy, 29121
AUSL Montecchio
Reggio Emilia, Italy, 42027
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Investigators
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Principal Investigator: Ivana Zavaroni, MD Azienda Ospedaliero-Universitaria Parma

Publications of Results:
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Responsible Party: Ivana Zavaroni, Associate Professor, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT02640768     History of Changes
Other Study ID Numbers: AOParma
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Keywords provided by Ivana Zavaroni, Azienda Ospedaliero-Universitaria di Parma:
in-hospital diabetes
clinical and management model
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases