Effect of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes.

OBJECTIVE: to assess the effects of self monitoring of blood glucose (SMBG) and urine glucose (SMUG) relative to usual care without self monitoring on diabetes related distress and on glycaemic control in patients with type 2 diabetes who are not using insulin.
STUDY DESIGN AND POPULATION: The study design is a randomized intervention study among 600 patients with type 2 diabetes with a glycated haemoglobin (HbA1c) concentration ¡Ý 7,0% who are not using insulin. Before randomization the patients will be stratified according to treatment (i.e. patients on sulphonylurea therapy or not). All patients are participants of the Diabetes Care System West-Friesland. INTERVENTION: The SMBG and SMUG will be an integral part of a wider educational strategy. The intervention groups and the control group will receive a standardised education program to change their diet and lifestyle. During 1 year, the intervention groups will perform SMBG or SMUG according to standard testing frequency instructions . The test results are used to modify diet, exercise and/or medications in consultation with the diabetes nurse who will give tailored made advice. PRIMARY OUTCOME MEASURES are distress (quality of life): problem areas in diabetes scale (PAID), Glycaemic control measured by HbA1c concentration, and cost effectiveness.

By applying self monitoring of glucose, patients with diabetes type 2 may cope more independently with their disease. Self monitoring can aid in diabetes control by giving the patient the ability to make appropriate day-to-day treatment choices in diet and physical activity as well as in medication. Furthermore, it will improve a patient's recognition of hypoglycaemia or severe hyperglycaemia, and enhance patient empowerment regarding the effects of lifestyle and medication on glycaemic control and thereby provide a better perceived quality of life.

A stratified, randomized 6-arm clinical trial among DM2 patients with a Hb1Ac of 7.0% or above who are not using insulin. Eligible and consenting subjects will be randomly assigned to the intervention groups self monitoring of blood glucose (SMBG) or self monitoring of urine glucose (SMUG), or to the control group. Before randomization the patients will be stratified according to treatment (i.e. using sulphonylureas (SU) or not (Non-SU)). The SMBG and SMUG will be an integral part of a wider educational strategy; the intervention groups and the control group will receive a standardised treatment program to change their diet and lifestyle. In addition, patients in the SMBG group will be educated to use the SMBG-device and patients in the SMUG-group will be educated to use the urine tests. They will learn to know and understand the ranges of test results and what steps to take in response to a high or low, or positive or negative reading. The intervention groups will perform self-monitoring according to standard testing frequency instructions during 1 year.