NCT02640768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,449

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable diabetes

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

3.2 years

First QC Date

November 19, 2015

Last Update Submit

December 22, 2015

Conditions

Diabetes

Keywords

in-hospital diabetesclinical and management model

Outcome Measures

Primary Outcomes (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

    Efficacy of educational training will be evaluated as absolute change of the performance scores after the intervention compared to baseline in the two groups

    11 months

Secondary Outcomes (6)

  • hypoglycemic events in the intervention and control wards

    11 months

  • severe hypoglycemic events in the intervention and control wards

    11 months

  • difference between plasma glycemia at admission and mean plasma glucose during the last-48-hours before discharge

    11 months

  • achievement of glycemic goals in the intervention and control wards

    11 months

  • survival rate during hospitalization in the intervention and control wards

    11 months

  • +1 more secondary outcomes

Study Arms (2)

educational training

EXPERIMENTAL

educational training

Other: educational training

no educational training

NO INTERVENTION

no educational training wards

Interventions

educational trainingOTHER

implementation of a structured educational program for physicians and nurses

educational training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AUSL Ospedale Maggiore

Bologna, Italy

Location

Azienda Ospedaliero-Universitaria

Ferrara, 44121, Italy

Location

AUSL Carpi

Modena, Italy

Location

Azienda Ospedaliero-Universitaria Parma

Parma, 43126, Italy

Location

AUSL Piacenza

Piacenza, 29121, Italy

Location

AUSL Montecchio

Reggio Emilia, 42027, Italy

Location

Related Publications (4)

  • Cook CB, Castro JC, Schmidt RE, Gauthier SM, Whitaker MD, Roust LR, Argueta R, Hull BP, Zimmerman RS. Diabetes care in hospitalized noncritically ill patients: More evidence for clinical inertia and negative therapeutic momentum. J Hosp Med. 2007 Jul;2(4):203-11. doi: 10.1002/jhm.188.

    PMID: 17683100RESULT

  • Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006 Feb 2;354(5):449-61. doi: 10.1056/NEJMoa052521.

    PMID: 16452557RESULT

  • American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.

    PMID: 18165335RESULT

  • Rossi MC, Lucisano G, Comaschi M, Coscelli C, Cucinotta D, Di Blasi P, Bader G, Pellegrini F, Valentini U, Vespasiani G, Nicolucci A; AMD-QUASAR Study Group. Quality of diabetes care predicts the development of cardiovascular events: results of the AMD-QUASAR study. Diabetes Care. 2011 Feb;34(2):347-52. doi: 10.2337/dc10-1709.

    PMID: 21270192RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Training Support

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Financial SupportEconomicsHealth Care Economics and Organizations

Study Officials

  • Ivana Zavaroni, MD

    Azienda Ospedaliero-Universitaria Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 19, 2015

First Posted

December 29, 2015

Study Start

January 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

IT(6)