Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287807
Status:
COMPLETED
Last Update Posted:
2011-09-26
First Post:
2006-01-30
Brief Title:
Effect of Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Not Using Insulin
Sponsor:
Medical Research Foundation The Netherlands
Organization:
Medical Research Foundation The Netherlands
Study Overview
Official Title:
Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Who Are Not Using Insulin A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None