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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Procedure: Treated and educated by nurses specialized in diabetes.


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Treated and educated by nurses specialized in diabetes.|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health related quality of life (HRQOL) |  |  | 
| diabetes related symptoms |  |  | 
| patients' satisfaction |  |  | 
| health care consumption and costs |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Delegation, Professional, Nurses