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

NCT00287807 | Completed Phase 3

• 1 other identifier: IC-06-02-SL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus, type 2; Blood Glucose Self-Monitoring; life style

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Research Foundation, The Netherlands: lead
• Langerhans Foundation, the Netherlands: collaborator

Study Sites (1)

Isala Clinics

Zwolle, 8000 GM, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Henk J Bilo, MD; PhD

  Isala Clinics, medical research foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 30, 2006
• First Posted: February 7, 2006
• Study Start: February 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 26, 2011

Record last verified: 2011-09

Locations

NL (1)