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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Keywords

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Randomized controlled trial Delegation, Professional Nurses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Treated and educated by nurses specialized in diabetes.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Sebastiaan T Houweling, PhD

Role: PRINCIPAL_INVESTIGATOR

2. Department of General Practice, University of Groningen, Groningen, The Netherlands

Betty Meyboom-de Jong, PhD

Role: STUDY_CHAIR

Department of General Practice, University of Groningen, Groningen, The Netherlands

Henk Bilo, PhD

Role: STUDY_CHAIR

3. Centre of Excellence, Isala Clinics, Zwolle, The Netherlands

Locations

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Isala Clinics

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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IC-06-03-SL

Identifier Type: -

Identifier Source: org_study_id