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Sponsors and Collaborators: |
Medical Research Foundation, The Netherlands Langerhans Foundation, the Netherlands |
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Information provided by: | Medical Research Foundation, The Netherlands |
ClinicalTrials.gov Identifier: | NCT00287807 |
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 | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Behavioral: Self-monitoring of blood glucose (SMBG) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Self-Monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Who Are Not Using Insulin. A Randomized Controlled Trial |
Estimated Enrollment: | 60 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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:
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Netherlands | |
Isala Clinics | |
Zwolle, Netherlands, 8000 GM |
Principal Investigator: | Henk J Bilo, MD; PhD | Isala Clinics, medical research foundation |
Responsible Party: | Diabetes Centre ( Prof. dr. H.J.G. Bilo ) |
Study ID Numbers: | IC-06-02-SL |
Study First Received: | January 30, 2006 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00287807 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Diabetes mellitus, type 2 Blood Glucose Self-Monitoring life style |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |