AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT00287807

Effect of Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Not Using Insulin

A Phase 3 study testing Self-monitoring of blood glucose (SMBG) in people with Diabetes Mellitus, Type 2, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Self-monitoring of blood glucose (SMBG) is one of the important instruments in diabetes management. Most patients with type 1 diabetes and patients with type 2 using insulin, frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate the insulin treatment and get information about… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Self-monitoring of blood glucose (SMBG)
How many people
60 participants
Where
1 siteNetherlands
Study dates
Feb 2006to Oct 2008
Phase
Phase 3
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes
  • HbA1c 7 - 8,5% at previous and present annual check-up
  • Use of 1 or 2 different oral blood glucose lowering drugs
  • In case of two oral blood glucose lowering drugs, they should not both have a maximum dosage
  • Sufficient knowledge of the Dutch language to understand the requirements for the study

Who cannot join

  • Change in oral blood glucose lowering drugs in the past three months
  • Use of insulin
  • Use of device for self-monitoring of blood glucose at the start of the study, or in the preceding 6 months

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Isala Clinics

    Zwolle, 8000 GM

Other trials in Netherlands

About this study

Official title: Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Who Are Not Using Insulin. A Randomized Controlled Trial

Self-monitoring of blood glucose (SMBG) is one of the important instruments in diabetes management. Most patients with type 1 diabetes and patients with type 2 using insulin, frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate the insulin treatment and get information about how to change the insulin regimen, if necessary. Without SMBG it is almost impossible to achieve this goal.

The purpose of this study is to determine if self-monitoring in patients with type 2 diabetes not using insulin results in better glycemic control.

Read the detailed description

Study Objectives:

Primary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on Glycemic control (as measured with glycosylated hemoglobin (HbA1c)?

Secondary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on the following parameters:

  • Health status
  • Diabetes related complaints
  • Patient satisfaction
  • Cumulative incidence of (necessity to start) insulin therapy / maximum dosage of oral blood glucose lowering drugs
  • Dosage of oral blood glucose lowering drugs
  • Bodyweight (BMI)

Two treatment protocols are proposed. Treatment A consists of self-monitoring of blood glucose and treatment B consists of usual care. Patients in the A-group are instructed to measure their blood glucose values 4 times a day (1 fasting plasma glucose concentration and 3 post-meal glucose concentrations), two times a week, on one week day, and one weekend day (no more, no less). Patients should record these glucose values in a diary. Patient will get one page with information in Dutch. No further education than for handling the device and interpreting the values is given, so that besides this intervention, there will be no differences compared with the control group like other forms of education.

The duration fo the trial will be 12 months.

Being tested
Self-monitoring of blood glucose (SMBG)
Keywords
Diabetes mellitus, type 2, Blood Glucose Self-Monitoring, life style
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.

  • Self-monitoring of blood glucose (SMBG)Behavioural

    2 times a week (one in weekend and one during week) self measurement of blood glucose: fasting and three times post prandial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic control; HbA1c at baseline, 3 months, 6 months, 9 months and 1 year (endpoint)

    Measured: baseline, 3 months, 6 months, 9 months and 1 year (endpoint)

Secondary outcomes (6)

  1. Quality of life; score on scale at baseline, 6 months and endpoint

    Measured: baseline, 6 months and endpoint

  2. Diabetes related complaints; score at baseline, 6 months and endpoint

    Measured: baseline, 6 months and endpoint

  3. Treatment satisfaction; score on scale at baseline, 6 months and endpoint

    Measured: baseline, 6 months and endpoint

  4. Incidence of (necessity to start) insulin therapy; at endpoint

    Measured: anywhere during the study

  5. dosage of oral blood glucose lowering drugs; at baseline, 6 months and endpoint

    Measured: baseline, 6 months and endpoint

  6. bodyweight; Bodymass index at baseline and endpoint

    Measured: baseline and endpoint

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00287807
Sponsor's protocol ID
IC-06-02-SL
Status last verified
Sep 2011
First submitted
30 Jan 2006
Last updated
26 Sep 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Self-monitoring of blood glucose (SMBG) 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 5 inclusion and 3 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 26 Sep 2011. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Glycemic control; HbA1c at baseline, 3 months, 6 months, 9 months and 1 year (endpoint) (time frame: baseline, 3 months, 6 months, 9 months and 1 year (endpoint)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00287807.

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 26 Sep 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in