Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin (ROSES)
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 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|
- 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.
- 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 ]
|Study Start Date:||March 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176149
|Consorzio Mario Negri Sud|
|Santa Maria Imbaro, Chieti, Italy, 66030|
|Study Director:||Antonio Nicolucci, MD||Consorzio Mario Negri Sud|