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

NCT ID: NCT01176149

Last Updated: 2010-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SMBG plus intensive education

Intervention Type: BEHAVIORAL

Usual Care

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SMBG plus intensive education

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LifeScan

INDUSTRY

Sponsor Role: collaborator

Consorzio Mario Negri Sud

OTHER

Sponsor Role: lead

Responsible Party

Consorzio Mario Negri Sud

Principal Investigators

Antonio Nicolucci, MD

Role: STUDY_DIRECTOR

Consorzio Mario Negri Sud

Locations

Consorzio Mario Negri Sud

Santa Maria Imbaro, Chieti, Italy

Countries

Italy

Other Identifiers

ROSES-01

Identifier Type: -

Identifier Source: org_study_id