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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: glucose meter; Device: BGStar

• Registration Number: NCT02082028
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2012-06-27
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-07
• Primary Completion: 2015-07-30
• Study Completion: 2015-07-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B (traditional approach)	glucose meter	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.
A (BGStar)	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.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c levels from baseline	baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
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
Percentage of participants with HbA1c ≤7.0%	at 12 months and 24 months
Quality of life: SF12 (Health Survey) questionnaire	at 12 months and 24 months
PDM (Patient involvement in the Decision Making process) questionnaire	at 12 months and 24 months
ADDQOL (Audit of Diabetes-Dependent Quality of Life)	at 12 months and 24 months
DTSQ (Diabetes Treatment Satisfaction Questionnaire)	at 12 months and 24 months
ABIM-14 (American Board of Internal Medicine satisfaction questionnaire)	at 12 months and 24 months
PHCO (Patient Health Care Orientation) questionnaire	at 12 months and 24 months
Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)	at 12 months and 24 months

Trial Locations

Locations (20)

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 004; 🇮🇹 Mariano Comense, Italy

Investigational Site Number 015; 🇮🇹 Lucca, Italy

Investigational Site Number 017; 🇮🇹 Messina, Italy

Investigational Site Number 008; 🇮🇹 Milano, Italy

Investigational Site Number 021; 🇮🇹 Potenza, Italy

Investigational Site Number 020; 🇮🇹 Ragusa, Italy

Investigational Site Number 018; 🇮🇹 Napoli, Italy

Investigational Site Number 019; 🇮🇹 Terlizzi (BA), Italy

Investigational Site Number 003; 🇮🇹 Udine, Italy

Investigational Site Number 014; 🇮🇹 Ravenna, Italy

Investigational Site Number 007; 🇮🇹 Torino, Italy

Investigational Site Number 009; 🇮🇹 Roma, Italy

Investigational Site Number 012; 🇮🇹 Rimini, Italy