Diabetes Mellitus, Type 2NCT00394875
The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes
A study testing Treated and educated by nurses specialized in diabetes. in people with Diabetes Mellitus, Type 2, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Treated and educated by nurses specialized in diabetes.
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2002to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with DM2 who were referred by GPs to the diabetes outpatient clinics
Who cannot join
- macroalbuminuria
- serum creatinine level > 135 mol/l,
- Cockcroft < 50 ml/min
- alanine aminotransferase (ALT) > 120 U/l
- pregnant woman
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Treated and educated by nurses specialized in diabetes.
- Keywords
- Randomized controlled trial, Delegation, Professional, Nurses
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treated and educated by nurses specialized in diabetes.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startMar 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants
Sponsor and investigators
- Lead sponsor
- Medical Research Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports, Langerhans Foundation, the Netherlands
- Investigators
- Sebastiaan T Houweling, PhD, Principal investigator, 2. Department of General Practice, University of Groningen, Groningen, The NetherlandsBetty Meyboom-de Jong, PhD, Study chair, Department of General Practice, University of Groningen, Groningen, The NetherlandsHenk Bilo, PhD, Study chair, 3. Centre of Excellence, Isala Clinics, Zwolle, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394875
- Sponsor's protocol ID
- IC-06-03-SL
- Status last verified
- Oct 2006
- First submitted
- 31 Oct 2006
- Last updated
- 2 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00394875
- Acronym / sponsor ID
- IC-06-03-SL
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Randomized controlled trial, Delegation, Professional, Nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants
- Lead sponsor
- Medical Research Foundation, The NetherlandsUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports, Langerhans Foundation, the Netherlands
- Study start
- Mar 2002
- Study completion
- Jan 2005
- First posted
- 2 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with DM2 who were referred by GPs to the diabetes outpatient clinics
Key exclusion criteria (5 listed)
- macroalbuminuria
- serum creatinine level > 135 mol/l,
- Cockcroft < 50 ml/min
- alanine aminotransferase (ALT) > 120 U/l
- pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treated and educated by nurses specialized in diabetes. | Procedure or surgery | – |
Primary outcome
mean decrease in:
HbA1c
blood pressure
total cholesterol
LDL cholesterol
cholesterol/HDL-ratio
proportion of patients achieving ranges of:
glycaemic control
lipid profile
4 secondary outcomes
health related quality of life (HRQOL)
diabetes related symptoms
patients' satisfaction
health care consumption and costs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastiaan T Houweling, PhD principal investigator
2. Department of General Practice, University of Groningen, Groningen, The Netherlands
Betty Meyboom-de Jong, PhD study chair
Department of General Practice, University of Groningen, Groningen, The Netherlands
Henk Bilo, PhD study chair
3. Centre of Excellence, Isala Clinics, Zwolle, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treated and educated by nurses specialized in diabetes. in people with Diabetes Mellitus, Type 2, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean decrease in:. The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2006.