Efficacy of a Chronic Care Model Supported by Self Monitoring of Blood Glucose With BGStar Over Usual Care in Improving Glycemic Control in Patients With Type 2 Diabetes Not Treated With Insulin

NCT ID: NCT02082028

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-27
• Study Completion Date: 2015-07-30

Brief Summary

To demonstrate the superiority of a chronic care model (SINERGIA model) supported by the Self Monitoring of Blood Glucose with BGStar over usual care in improving glycemic control at 12 months in patients with type 2 diabetes not treated with insulin.

Detailed Description

The planned study duration is 36 months (9 quarters). The estimated duration of screening/enrollment will be 12 months, followed by the 12-month experimental phase, plus the 12-month follow-up in the observational phase.

Conditions

Diabetes Mellitus

Study Design

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

Study Groups

A (BGStar)

Patients will be educated within the context of the SINERGIA educational program to understand how to manage their own diabetes on the basis of their Self Monitoring of Blood Glucose values obtained with BGStar. Patients will be requested two 6-points profiles monthly.

Group Type: EXPERIMENTAL

BGStar

Intervention Type: DEVICE

B (traditional approach)

Usual approach for the disease management. Patients in Group B will receive usual education and, at any time during the study duration, if needed, will be instructed on Self Monitoring of Blood Glucose, performed with any glucose meter.

Group Type: ACTIVE_COMPARATOR

glucose meter

Intervention Type: DEVICE

Interventions

BGStar

Intervention Type: DEVICE

glucose meter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Males and females
• Age ≥ 45 years
• Type 2 diabetes
• First access at the diabetes clinic
• Any diabetes duration
• HbA1c >7.0 and ≤ 9.0%
• Already treated with any oral antidiabetic agent (OAD) or requiring the initiation of therapy with OAD
• Patients not using SMBG or using SMBG with a frequency ≤1 test/week
• Written informed consent

Exclusion Criteria

Treatment with insulin or need to start insulin regimens or continuous sub-cutaneous insulin infusion at the first access; Refusal or inability to give informed consent to participate in the study;

Conditions / situations such as:

• Patients with short life expectancy;
• Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment;
• Requirement for concomitant treatment that could bias primary evaluation (i.e. corticosteroid treatment);
• Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study;
• Current addition/abuse of alcohol or drugs;
• Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study;
• Pregnant or breast-feeding women;
• Patients living too far from investigational center or other conditions reducing the adherence to the protocol; Subjects unlikely or unable to comply with the Protocol requirements (e.g. illiterate, uncooperative, unable to return for follow-up visit, unable to use BGStar unlikely to complete the study)

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

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Science & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 016

Andria (BA), , Italy

Investigational Site Number 011

Avezzano, , Italy

Investigational Site Number 006

Bergamo, , Italy

Investigational Site Number 002

Brescia, , Italy

Investigational Site Number 022

Catania, , Italy

Investigational Site Number 001

Cusano Milanino, , Italy

Investigational Site Number 013

Livorno, , Italy

Investigational Site Number 015

Lucca, , Italy

Investigational Site Number 004

Mariano Comense, , Italy

Investigational Site Number 017

Messina, , Italy

Investigational Site Number 008

Milan, , Italy

Investigational Site Number 018

Napoli, , Italy

Investigational Site Number 021

Potenza, , Italy

Investigational Site Number 020

Ragusa, , Italy

Investigational Site Number 014

Ravenna, , Italy

Investigational Site Number 012

Rimini, , Italy

Investigational Site Number 009

Roma, , Italy

Investigational Site Number 019

Terlizzi (BA), , Italy

Investigational Site Number 007

Torino, , Italy

Investigational Site Number 003

Udine, , Italy

Countries

Italy

Other Identifiers

BGSTA_L_05978

Identifier Type: -

Identifier Source: org_study_id