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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 in a Secondary Care Setting: a Randomized Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00394875
Enrollment
81
Registered
2006-11-02
Start date
2002-03-31
Completion date
2005-01-31
Last updated
2006-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Randomized controlled trial, Delegation, Professional, Nurses

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.

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.

Interventions

PROCEDURETreated and educated by nurses specialized in diabetes.

Sponsors

Netherlands: Ministry of Health, Welfare and Sports
CollaboratorOTHER_GOV
Langerhans Foundation, the Netherlands
CollaboratorOTHER
Medical Research Foundation, The Netherlands
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026