The Diabetes Specialist Nurse as Delegated Main Care Pr...

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

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

This study has been completed.
Sponsors and Collaborators: Medical Research Foundation, The Netherlands
Netherlands: Ministry of Health, Welfare and Sports
Langerhans Foundation, the Netherlands

Information provided by: Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT00394875

Purpose
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 Intervention
Diabetes Mellitus, Type 2
Procedure: Treated and educated by nurses specialized in diabetes.

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
mean decrease in:

HbA1c

blood pressure

total cholesterol

LDL cholesterol

cholesterol/HDL-ratio

proportion of patients achieving ranges of:

glycaemic control

lipid profile

Secondary Outcome Measures:
health related quality of life (HRQOL)

diabetes related symptoms

patients' satisfaction

health care consumption and costs

Estimated Enrollment:81
Study Start Date:March 2002
Estimated Study Completion Date:January 2005

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.

Eligibility
Genders Eligible for Study:Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:IC-06-03-SL
First Received:October 31, 2006
Last Updated:October 31, 2006
ClinicalTrials.gov Identifier:NCT00394875 [history]
Health Authority:Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Neoplasm Metastasis
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders