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

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394875
• Other study ID #: IC-06-03-SL
• Status: Completed
• Phase: N/A
• First received: October 31, 2006
• Last updated: October 31, 2006
• Start date: March 2002
• Est. completion date: January 2005

Study information

• Verified date: October 2006
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Procedure:
• Treated and educated by nurses specialized in diabetes.

Locations

Country	Name	City	State
Netherlands	Isala Clinics	Zwolle

Sponsors (3)

Lead Sponsor	Collaborator
Medical Research Foundation, The Netherlands	Langerhans Foundation, the Netherlands, Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean decrease in:
Primary	HbA1c
Primary	blood pressure
Primary	total cholesterol
Primary	LDL cholesterol
Primary	cholesterol/HDL-ratio
Primary	proportion of patients achieving ranges of:
Primary	glycaemic control
Primary	lipid profile
Secondary	health related quality of life (HRQOL)
Secondary	diabetes related symptoms
Secondary	patients' satisfaction
Secondary	health care consumption and costs