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

Sponsor

Medical Research Foundation, The Netherlands (Other)

Overall Status

Completed

CT.gov ID

NCT00394875

Collaborator

Netherlands: Ministry of Health, Welfare and Sports (Other), Langerhans Foundation, the Netherlands (Other)

Enrollment

Location

34.1

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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	Phase
Diabetes Mellitus, Type 2	Procedure: Treated and educated by nurses specialized in diabetes.	N/A

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

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 :

Mar 1, 2002

Study Completion Date :

Jan 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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