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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00287807
• Lead Sponsor: Medical Research Foundation, The Netherlands

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.

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.

Study Timeline

• Study First Submitted: 2006-01-30
• Study Start: 2006-02
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-23
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Isala Clinics; 🇳🇱 Zwolle, Netherlands