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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Self-monitoring of blood glucose (SMBG)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control; HbA1c at baseline, 3 months, 6 months, 9 months and 1 year (endpoint) |  | baseline, 3 months, 6 months, 9 months and 1 year (endpoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life; score on scale at baseline, 6 months and endpoint |  | baseline, 6 months and endpoint | 
| Diabetes related complaints; score at baseline, 6 months and endpoint |  | baseline, 6 months and endpoint | 
| Treatment satisfaction; score on scale at baseline, 6 months and endpoint |  | baseline, 6 months and endpoint | 
| Incidence of (necessity to start) insulin therapy; at endpoint |  | anywhere during the study | 
| dosage of oral blood glucose lowering drugs; at baseline, 6 months and endpoint |  | baseline, 6 months and endpoint | 
| bodyweight; Bodymass index at baseline and endpoint |  | baseline and endpoint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, type 2, Blood Glucose Self-Monitoring, life style