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Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes

NCT01460459 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2011-10-26

No results posted yet for this study

Summary

Primary Objective:

The objective of the study is to investigate the effect of a specific frequency of Self-monitoring of blood glucose (SMBG) on glycemic control and quality of life in patients with type 2 diabetes and who are in stable good glycemic control and using 1 insulin injection daily.

The research question is:

Does a less intensive frequency of SMBG in insulin-treated patients with type 2 diabetes, who are in stable good glycemic control, using 1 insulin injection daily, lead to a clinically relevant increase of HbA1c (an increase of 0.5%) and what is the effect on quality of life?

Secondary objectives:

The secondary objectives is to investigate the effect of a specific frequency of SMBG on the number of hypo and hyper glycaemia, number of extra diabetes-related contacts with the health care provider, and the diabetes medication.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

a specific frequency of SMBG

Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime: high frequency: one day weekly middle frequency:one day per two weeks low frequency:one day monthly

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Medical Research Foundation, The Netherlands

    lead OTHER

Principal Investigators

  • Henk JG Bilo, MD PhD FCRP · Isala

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-12-31
Completion
2012-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01460459 on ClinicalTrials.gov