Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin (ROSES)

August 5, 2010 updated by: Consorzio Mario Negri Sud

Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin: a Pilot Study

The aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely changes in therapy, when needed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Chieti
      • Santa Maria Imbaro, Chieti, Italy, 66030
        • Consorzio Mario Negri Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
  • Patients on treatment with OHA monotherapy (i.e. metformin alone or sulphonylureas alone or TZDs alone);
  • No need for insulin treatment;
  • Male and female patients, aged between 45-75 years;
  • Hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
  • No experience of self monitoring of blood glucose in the previous 12 months (SMBG performed with a frequency of < 1 times/week)
  • Ability and willingness to comply with all study requirements
  • Signature of consent form

Exclusion Criteria:

  • Patients incapable to perform SMBG
  • Patients needing insulin or multiple OHA association therapy
  • Patients needing a regular use of SMBG (e.g. frequent hypoglycemic episodes)
  • Diabetes care not exclusively managed by diabetic clinics
  • Patients with serious underlying medical or psychiatric condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: SMBG + intensive education
Patients will receive specific educational interventions to teach them how to perform Self monitoring Blood Glucose (SMBG), how to modify diet and level of physical activity according to blood glucose levels, and the actions to be undertaken in case of abnormal values (hypoglycemia, particularly elevated glucose levels). Patients will be instructed to modify their lifestyle habits (diet, physical activity) in order to reach specific goals (weight reduction, reduction in fat consumption intake, reduction in saturated fat intake, increase in fiber intake, regular physical activity.
Behavioral: SMBG plus intensive education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Improvement of metabolic control
Aim of this study is to evaluate the efficacy of Self Monitoring Blood Glucose and Intensive Education in terms of improvement of metabolic control expressed as HbA1c levels after 6 months.

Secondary Outcome Measures

Outcome Measure
Reduction in prandial Blood Glucose excursions
Percentage of patients needing therapy modifications
Percentage of patients reaching target HbA1c (i.e. <7.0%)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorzio Mario Negri Sud

Collaborators

LifeScan

Investigators

  • Study Director: Antonio Nicolucci, MD, Consorzio Mario Negri Sud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (Estimate)

August 5, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2010

Last Update Submitted That Met QC Criteria

August 5, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROSES-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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