Effect of Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Not Using Insulin
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|ClinicalTrials.gov Identifier: NCT00287807|
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : September 26, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Self-monitoring of blood glucose (SMBG)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Who Are Not Using Insulin. A Randomized Controlled Trial|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
- 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
- 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) ]
- Quality of life; score on scale at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ]
- Diabetes related complaints; score at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ]
- Treatment satisfaction; score on scale at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ]
- Incidence of (necessity to start) insulin therapy; at endpoint [ Time Frame: anywhere during the study ]
- dosage of oral blood glucose lowering drugs; at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ]
- bodyweight; Bodymass index at baseline and endpoint [ Time Frame: baseline and endpoint ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287807
|Zwolle, Netherlands, 8000 GM|
|Principal Investigator:||Henk J Bilo, MD; PhD||Isala Clinics, medical research foundation|