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.
Sponsor:
Collaborator:
LifeScan
Information provided by:
Consorzio Mario Negri Sud
ClinicalTrials.gov Identifier:
NCT01176149
First received: August 4, 2010
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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
Endpoint Classification: Efficacy Study
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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
  • Percentage of patients needing therapy modifications [ Designated as safety issue: No ]
  • Percentage of patients reaching target HbA1c (i.e. <7.0%) [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01176149

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on August 19, 2014