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Completed

NCT Number: NCT00287807

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Isala Clinics

Zwolle, 8000 GM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-monitoring of blood glucose (SMBG)

Behavioral

2 times a week (one in weekend and one during week) self measurement of blood glucose: fasting and three times post prandial

Primary outcomes

  1. Glycemic control; HbA1c at baseline, 3 months, 6 months, 9 months and 1 year (endpoint)

    Time frame: baseline, 3 months, 6 months, 9 months and 1 year (endpoint)

Secondary outcomes

  1. Quality of life; score on scale at baseline, 6 months and endpoint

    Time frame: baseline, 6 months and endpoint

  2. Diabetes related complaints; score at baseline, 6 months and endpoint

    Time frame: baseline, 6 months and endpoint

  3. Treatment satisfaction; score on scale at baseline, 6 months and endpoint

    Time frame: baseline, 6 months and endpoint

  4. Incidence of (necessity to start) insulin therapy; at endpoint

    Time frame: anywhere during the study

  5. dosage of oral blood glucose lowering drugs; at baseline, 6 months and endpoint

    Time frame: baseline, 6 months and endpoint

  6. bodyweight; Bodymass index at baseline and endpoint

    Time frame: baseline and endpoint

Sponsors and collaborators

Lead sponsor

Medical Research Foundation, The Netherlands

Other

Collaborators

  • Langerhans Foundation, the Netherlands

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 7, 2006
Registry last updated
Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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