NCT00394875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2002

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
Last Updated

November 2, 2006

Status Verified

October 1, 2006

First QC Date

October 31, 2006

Last Update Submit

October 31, 2006

Conditions

Diabetes Mellitus, Type 2

Keywords

Randomized controlled trialDelegation, ProfessionalNurses

Outcome Measures

Primary Outcomes (9)

  • mean decrease in:

  • HbA1c

  • blood pressure

  • total cholesterol

  • LDL cholesterol

  • cholesterol/HDL-ratio

  • proportion of patients achieving ranges of:

  • glycaemic control

  • lipid profile

Secondary Outcomes (4)

  • health related quality of life (HRQOL)

  • diabetes related symptoms

  • patients' satisfaction

  • health care consumption and costs

Interventions

Treated and educated by nurses specialized in diabetes.PROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with DM2 who were referred by GPs to the diabetes outpatient clinics

You may not qualify if:

  • macroalbuminuria
  • serum creatinine level \> 135 mol/l,
  • Cockcroft \< 50 ml/min
  • alanine aminotransferase (ALT) \> 120 U/l
  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Clinics

Zwolle, 8025 AB, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sebastiaan T Houweling, PhD

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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 2, 2006

Study Start

March 1, 2002

Study Completion

January 1, 2005

Last Updated

November 2, 2006

Record last verified: 2006-10

Locations

NL(1)