Clinical trial NCT00287807: Effect of Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Not Using Insulin
Official title: Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Who Are Not Using Insulin. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus, type 2
Blood Glucose Self-Monitoring
life style
Lead sponsor: Medical Research Foundation, The Netherlands
Sponsor class: OTHER
Collaborators: name: Langerhans Foundation, the Netherlands
First posted: 2006-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic control; HbA1c at baseline, 3 months, 6 months, 9 months and 1 year (endpoint)
timeFrame: baseline, 3 months, 6 months, 9 months and 1 year (endpoint)
Secondary outcomes:
measure: Quality of life; score on scale at baseline, 6 months and endpoint
timeFrame: baseline, 6 months and endpoint
measure: Diabetes related complaints; score at baseline, 6 months and endpoint
timeFrame: baseline, 6 months and endpoint
measure: Treatment satisfaction; score on scale at baseline, 6 months and endpoint
timeFrame: baseline, 6 months and endpoint
measure: Incidence of (necessity to start) insulin therapy; at endpoint
timeFrame: anywhere during the study
measure: dosage of oral blood glucose lowering drugs; at baseline, 6 months and endpoint
timeFrame: baseline, 6 months and endpoint
measure: bodyweight; Bodymass index at baseline and endpoint
timeFrame: baseline and endpoint
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Clinics
Study officials:
affiliation: Isala Clinics, medical research foundation
name: Henk J Bilo, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: