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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Who Are Not Using Insulin. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287807
• Other study ID #: IC-06-02-SL
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2006
• Last updated: September 23, 2011
• Start date: February 2006
• Est. completion date: October 2008

Study information

• Verified date: September 2011
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Type 2 diabetes

• HbA1c 7 - 8,5% at previous and present annual check-up

• Use of 1 or 2 different oral blood glucose lowering drugs

• In case of two oral blood glucose lowering drugs, they should not both have a maximum dosage

• Sufficient knowledge of the Dutch language to understand the requirements for the study

Exclusion criteria:

• Change in oral blood glucose lowering drugs in the past three months

• Use of insulin

• Use of device for self-monitoring of blood glucose at the start of the study, or in the preceding 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Netherlands	Isala Clinics	Zwolle

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Foundation, The Netherlands	Langerhans Foundation, the Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Quality of life; score on scale at baseline, 6 months and endpoint		baseline, 6 months and endpoint	No
Secondary	Diabetes related complaints; score at baseline, 6 months and endpoint		baseline, 6 months and endpoint	Yes
Secondary	Treatment satisfaction; score on scale at baseline, 6 months and endpoint		baseline, 6 months and endpoint	No
Secondary	Incidence of (necessity to start) insulin therapy; at endpoint		anywhere during the study	No
Secondary	dosage of oral blood glucose lowering drugs; at baseline, 6 months and endpoint		baseline, 6 months and endpoint	No
Secondary	bodyweight; Bodymass index at baseline and endpoint		baseline and endpoint	No