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The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00394875
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : November 2, 2006
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
To determine whether the management of type 2 diabetes mellitus (DM2) can be transferred from an internist to a supervised nurse specialized in diabetes (NSD) with a comparable quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Procedure: Treated and educated by nurses specialized in diabetes.

Detailed Description:
Diabetes mellitus type 2 (DM2) is a chronic, progressive illness which causes considerable morbidity and premature mortality.1-2 The worldwide prevalence of DM2 is high and is increasing steadily, also in The Netherlands.3-4 The burden of DM2 on health care has also increased because of the intensified cardiovascular risk management being practiced to prevent macrovascular morbidity and mortality in these patients.5 In the treatment of DM2, tight guidelines are increasingly recommended for optimizing glycaemia, blood pressure and lipid profile.6 Therefore, the burden of treatment has increased and will further increase per patient as well as per population with DM2. In order to meet this problem, we tested, in the current study, the hypothesis that well defined routine aspects in diabetes care, previously handled only by medical doctors in secondary care setting, may be safely transferred to supervised nurses specialized in diabetes (NSD), including the prescription of medication, resulting in at least the same quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes in a Secondary Care Setting: a Randomized Controlled Trial.
Study Start Date : March 2002
Estimated Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. mean decrease in:
  2. HbA1c
  3. blood pressure
  4. total cholesterol
  5. LDL cholesterol
  6. cholesterol/HDL-ratio
  7. proportion of patients achieving ranges of:
  8. glycaemic control
  9. lipid profile

Secondary Outcome Measures :
  1. health related quality of life (HRQOL)
  2. diabetes related symptoms
  3. patients' satisfaction
  4. health care consumption and costs

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with DM2 who were referred by GPs to the diabetes outpatient clinics

Exclusion Criteria:

  • macroalbuminuria
  • serum creatinine level > 135 mol/l,
  • Cockcroft < 50 ml/min
  • alanine aminotransferase (ALT) > 120 U/l
  • pregnant woman
Contacts and Locations

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): NCT00394875


Locations
Netherlands
Isala Clinics
Zwolle, Netherlands, 8025 AB
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Netherlands: Ministry of Health, Welfare and Sports
Langerhans Foundation, the Netherlands
Investigators
Principal Investigator: Sebastiaan T Houweling, PhD 2. Department of General Practice, University of Groningen, Groningen, The Netherlands
Study Chair: Betty Meyboom-de Jong, PhD Department of General Practice, University of Groningen, Groningen, The Netherlands
Study Chair: Henk Bilo, PhD 3. Centre of Excellence, Isala Clinics, Zwolle, The Netherlands
More Information

ClinicalTrials.gov Identifier: NCT00394875     History of Changes
Other Study ID Numbers: IC-06-03-SL
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: November 2, 2006
Last Verified: October 2006

Keywords provided by Medical Research Foundation, The Netherlands:
Randomized controlled trial
Delegation, Professional
Nurses

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