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| Sponsors and Collaborators: |
Medical Research Foundation, The Netherlands Netherlands: Ministry of Health, Welfare and Sports Langerhans Foundation, the Netherlands |
|---|---|
| Information provided by: | Medical Research Foundation, The Netherlands |
| ClinicalTrials.gov Identifier: | NCT00394875 |
Purpose
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 | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Procedure: Treated and educated by nurses specialized in diabetes. |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| 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. |
| Estimated Enrollment: | 81 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | January 2005 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| Isala Clinics | |
| Zwolle, Netherlands, 8025 AB | |
| 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 |
More Information
| Study ID Numbers: | IC-06-03-SL |
| Study First Received: | October 31, 2006 |
| Last Updated: | October 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00394875 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Randomized controlled trial Delegation, Professional Nurses |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Neoplasm Metastasis |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |
