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Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial

This study has been completed.
Sponsor:
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00277732
First received: January 13, 2006
Last updated: December 19, 2007
Last verified: December 2007
History of Changes
  Purpose

The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical care at baseline and follow-up visits over 6 months).


Condition Intervention
Diabetes Mellitus
 Procedure: Pharmaceutical care at baseline and follow-up visits over 6 months

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • The difference between the study groups in the change of blood glucose and HbA1c [ Time Frame: baseline and after 6 months ]

Secondary Outcome Measures:
  • Knowledge about diabetes and treatment [ Time Frame: after 6 months ]
  • Therapy adherence
  • Body Mass Index [ Time Frame: after 6 months ]
  • Periods of severe hypoglycemia
  • GP visits, emergency room visits and hospitalisations
  • Work days lost
  • Frequency of eye and foot examination

Enrollment: 288
Study Start Date: January 2006
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 45-75 years
  • Body Mass Index >= 25
  • Diabetes treatment for at least 12 months
  • Regular visitors of the participating community pharmacy

Exclusion Criteria:

  • Patients taking only insulin (no oral antidiabetic drugs)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277732

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Mimi Giri, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website University Ghent  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00277732     History of Changes
Other Study ID Numbers: 2005/340
Study First Received: January 13, 2006
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013