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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Self-monitoring of blood glucose (SMBG)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Nanne Kleefstra

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henk J Bilo, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

Isala Clinics, medical research foundation

Locations

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Isala Clinics

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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IC-06-02-SL

Identifier Type: -

Identifier Source: org_study_id