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

NCT02082028 | Completed

• 1 other identifier: BGSTA_L_05978
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 20

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c levels from baseline

  baseline to 12 months

Secondary Outcomes (12)

• Percentage of participants with HbA1c ≤7.0%

  at 12 months and 24 months

• Variation in body weight from baseline

  at 12 months and 24 months

• Variation in waist circumference from baseline

  at 12 months and 24 months

• Variation in blood pressure from baseline

  at 12 months and 24 months

• Variation in lipid profile from baseline

  at 12 months and 24 months

Study Arms (2)

A (BGStar)

EXPERIMENTAL

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.

Device: BGStar

B (traditional approach)

ACTIVE COMPARATOR

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.

Device: glucose meter

Interventions

BGStar DEVICE

A (BGStar)

glucose meter DEVICE

B (traditional approach)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sanofi: lead

Study Sites (20)

Investigational Site Number 016

Andria (BA), Italy

Location

Investigational Site Number 011

Avezzano, Italy

Location

Investigational Site Number 006

Bergamo, 24128, Italy

Location

Investigational Site Number 002

Brescia, Italy

Location

Investigational Site Number 022

Catania, 95122, Italy

Location

Investigational Site Number 001

Cusano Milanino, Italy

Location

Investigational Site Number 013

Livorno, Italy

Location

Investigational Site Number 015

Lucca, Italy

Location

Investigational Site Number 004

Mariano Comense, Italy

Location

Investigational Site Number 017

Messina, Italy

Location

Investigational Site Number 008

Milan, Italy

Location

Investigational Site Number 018

Napoli, Italy

Location

Investigational Site Number 021

Potenza, Italy

Location

Investigational Site Number 020

Ragusa, Italy

Location

Investigational Site Number 014

Ravenna, Italy

Location

Investigational Site Number 012

Rimini, 47900, Italy

Location

Investigational Site Number 009

Roma, Italy

Location

Investigational Site Number 019

Terlizzi (BA), Italy

Location

Investigational Site Number 007

Torino, Italy

Location

Investigational Site Number 003

Udine, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Science & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 7, 2014
• Study Start: June 27, 2012
• Primary Completion: July 30, 2015
• Study Completion: July 30, 2015
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

IT (20)