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

This study has been completed.
Information provided by:
Consorzio Mario Negri Sud Identifier:
First received: August 4, 2010
Last updated: August 5, 2010
Last verified: August 2010
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.

Condition Intervention Phase
Type 2 Diabetes
Behavioral: SMBG plus intensive education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin: a Pilot Study

Resource links provided by NLM:

Further study details as provided by Consorzio Mario Negri Sud:

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

Enrollment: 62
Study Start Date: March 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: Usual Care
Usual Care


Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01176149

Consorzio Mario Negri Sud
Santa Maria Imbaro, Chieti, Italy, 66030
Sponsors and Collaborators
Consorzio Mario Negri Sud
Study Director: Antonio Nicolucci, MD Consorzio Mario Negri Sud
  More Information

Responsible Party: Antonio Nicolucci / Scientific responsible, Consorzio Mario Negri Sud Identifier: NCT01176149     History of Changes
Other Study ID Numbers: ROSES-01
Study First Received: August 4, 2010
Last Updated: August 5, 2010

Keywords provided by Consorzio Mario Negri Sud:
Self monitoring blood glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 25, 2017