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

NCT01176149 | Completed Phase 3

• 1 other identifier: ROSES-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Self monitoring blood glucose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reduction in prandial Blood Glucose excursions

• Percentage of patients needing therapy modifications

• Percentage of patients reaching target HbA1c (i.e. <7.0%)

Study Arms (2)

SMBG + intensive education

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Usual Care

Interventions

SMBG plus intensive education BEHAVIORAL

SMBG + intensive education

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorzio Mario Negri Sud: lead
• LifeScan: collaborator

Study Sites (1)

Consorzio Mario Negri Sud

Santa Maria Imbaro, Chieti, 66030, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Antonio Nicolucci, MD

  Consorzio Mario Negri Sud

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 5, 2010
• Study Start: March 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 6, 2010

Record last verified: 2010-08

Locations

IT (1)