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

Medical Research Foundation, The Netherlands

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: Self-monitoring of blood glucose (SMBG)

Study type

Interventional

Funder types

Other

Identifiers

NCT00287807

IC-06-02-SL

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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