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

This study has been completed.
Sponsor:
Collaborator:
Langerhans Foundation, the Netherlands
Information provided by (Responsible Party):
Nanne Kleefstra, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT00287807
First received: January 30, 2006
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Behavioral: Self-monitoring of blood glucose (SMBG)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Who Are Not Using Insulin. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life; score on scale at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ] [ Designated as safety issue: No ]
  • Diabetes related complaints; score at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ] [ Designated as safety issue: Yes ]
  • Treatment satisfaction; score on scale at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ] [ Designated as safety issue: No ]
  • Incidence of (necessity to start) insulin therapy; at endpoint [ Time Frame: anywhere during the study ] [ Designated as safety issue: No ]
  • dosage of oral blood glucose lowering drugs; at baseline, 6 months and endpoint [ Time Frame: baseline, 6 months and endpoint ] [ Designated as safety issue: No ]
  • bodyweight; Bodymass index at baseline and endpoint [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287807

Locations
Netherlands
Isala Clinics
Zwolle, Netherlands, 8000 GM
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Langerhans Foundation, the Netherlands
Investigators
Principal Investigator: Henk J Bilo, MD; PhD Isala Clinics, medical research foundation
  More Information

No publications provided

Responsible Party: Nanne Kleefstra, MD PhD, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT00287807     History of Changes
Other Study ID Numbers: IC-06-02-SL
Study First Received: January 30, 2006
Last Updated: September 23, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:
Diabetes mellitus, type 2
Blood Glucose Self-Monitoring
life style

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014