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

October 31, 2006 updated by: Medical Research Foundation, The Netherlands

The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes in a Secondary Care Setting: a Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zwolle, Netherlands, 8025 AB
        • Isala Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c
blood pressure
LDL cholesterol
total cholesterol
lipid profile
mean decrease in:
cholesterol/HDL-ratio
proportion of patients achieving ranges of:
glycaemic control

Secondary Outcome Measures

Outcome Measure
health related quality of life (HRQOL)
diabetes related symptoms
patients' satisfaction
health care consumption and costs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Foundation, The Netherlands

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion

January 1, 2005

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 2, 2006

Study Record Updates

Last Update Posted (Estimate)

November 2, 2006

Last Update Submitted That Met QC Criteria

October 31, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC-06-03-SL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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